Trial Outcomes & Findings for Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue) (NCT NCT02538042)
NCT ID: NCT02538042
Last Updated: 2018-11-14
Results Overview
Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence. The score of the questionnaire ranges in value from 0 (not at all dependent) to 10 (highly dependent).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
baseline - week 6
Results posted on
2018-11-14
Participant Flow
This study enrolled adult daily smokers from the Raleigh-Durham region in North Carolina who reported interest in quitting smoking
Eighty-seven participants were enrolled and assessed for eligibility. Thirty-eight of those did not meet inclusion criteria (n=29), or withdrew (n=7) or were lost to contact (n=2) prior to baseline. Forty-nine participants completed the baseline cue-reactivity session and 34 returned for their randomization visit.
Participant milestones
| Measure |
MCE+
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
|
MCE- (Control)
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
Completed All MCE Sessions
|
15
|
15
|
|
Overall Study
Attended Post-Quit Visit
|
15
|
14
|
|
Overall Study
Completed All Post-Quit Visits
|
12
|
12
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)
Baseline characteristics by cohort
| Measure |
MCE+
n=17 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
|
MCE- (Control)
n=17 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
48.4 years
STANDARD_DEVIATION 9.1 • n=107 Participants
|
46.2 years
STANDARD_DEVIATION 11.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Cigarettes per day
|
16.94 cigarettes per day
STANDARD_DEVIATION 7.94 • n=99 Participants
|
21.88 cigarettes per day
STANDARD_DEVIATION 10.21 • n=107 Participants
|
19.41 cigarettes per day
STANDARD_DEVIATION 9.35 • n=206 Participants
|
|
Fagerstrom Test for Nicotine Dependence (FTND) score
|
4.47 units on a scale
STANDARD_DEVIATION 2.27 • n=99 Participants
|
5.47 units on a scale
STANDARD_DEVIATION 2.12 • n=107 Participants
|
4.97 units on a scale
STANDARD_DEVIATION 2.22 • n=206 Participants
|
PRIMARY outcome
Timeframe: baseline - week 6Population: Number analyzed represents all participants who completed treatment.
Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence. The score of the questionnaire ranges in value from 0 (not at all dependent) to 10 (highly dependent).
Outcome measures
| Measure |
MCE+
n=15 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prio
|
MCE- (Control)
n=15 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei
|
|---|---|---|
|
Change in Fagerstrom Test of Nicotine Dependence Score
|
.67 score on a scale
Standard Deviation 2.61
|
1.33 score on a scale
Standard Deviation 1.35
|
PRIMARY outcome
Timeframe: week 16Population: All participants randomized to treatment, and completing at least one treatment session
Effects of MCE+ (vs. MCE-) on smoking cessation outcomes. Relapse is defined as 7 consecutive days of smoking. Outcome reported as number of participants who met relapse definition.
Outcome measures
| Measure |
MCE+
n=17 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prio
|
MCE- (Control)
n=17 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei
|
|---|---|---|
|
Number of Participants Who Met Relapse Criteria
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: week 1, week 6Population: Number in each group represents the number of participants who completed the pretreatment phase.
Compliance with smoking VLNCs. Reduction in usual brand (UB) cigarette use over the treatment period will be calculated for each group. Average usual brand cigarettes per day was calculated using the average number for the first 5 days of treatment (week 1) and the average number for the last 5 days of treatment (week 6). Values were calculated as number smoked at W1 minus the number smoked at W6.
Outcome measures
| Measure |
MCE+
n=15 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prio
|
MCE- (Control)
n=15 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei
|
|---|---|---|
|
Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement)
|
0 mean difference in UB cigarettes smoked
Standard Deviation 0
|
-1.32 mean difference in UB cigarettes smoked
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: week 3, week 6Population: represents all participants who completed both week 3 and week 6 assessments
Reduction in total cigarette use over the treatment period will be calculated for each group. Average cigarettes per day was calculated using the average number for the 5 days leading up to week 3 and the average number for the 5 days leading up to week 6. Values were calculated as number smoked at W3 minus the number smoked at W6. Positive values represent a decrease in smoking behavior.
Outcome measures
| Measure |
MCE+
n=15 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prio
|
MCE- (Control)
n=15 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei
|
|---|---|---|
|
Change in Number of Cigarettes Smoked Per Day (EXT Response)
|
3.05 mean difference in cigarettes smoked
Standard Deviation 5.34
|
-.35 mean difference in cigarettes smoked
Standard Deviation 9.55
|
SECONDARY outcome
Timeframe: week 3, week 4, week 5Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving)
Outcome measures
| Measure |
MCE+
n=15 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prio
|
MCE- (Control)
n=15 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei
|
|---|---|---|
|
Change in Craving Score During MCE Task (MCE Response)
Week 4 average
|
11.88 score on a scale
Standard Deviation 19.67
|
4.29 score on a scale
Standard Deviation 10.15
|
|
Change in Craving Score During MCE Task (MCE Response)
Week 3 average
|
14.58 score on a scale
Standard Deviation 24.12
|
0.98 score on a scale
Standard Deviation 2.09
|
|
Change in Craving Score During MCE Task (MCE Response)
Week 5 average
|
8.25 score on a scale
Standard Deviation 12.25
|
1.34 score on a scale
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: baseline ,week 6Population: The number of participants analyzed represents those who completed the entire pretreatment phase in each group.
Difference in craving responses. Craving at each time point was measured on a scale from 0 (no craving) to 100 (strong craving). Value reported represents difference in baseline - week 6.
Outcome measures
| Measure |
MCE+
n=15 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prio
|
MCE- (Control)
n=14 Participants
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei
|
|---|---|---|
|
Change in Post-quit Cue-reactivity
|
23.2 units on a scale
Standard Deviation 26.3
|
15.2 units on a scale
Standard Deviation 21.0
|
Adverse Events
MCE+
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
MCE- (Control)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MCE+
n=17 participants at risk
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prio
|
MCE- (Control)
n=17 participants at risk
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei
|
|---|---|---|
|
Vascular disorders
hypertension
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
Other adverse events
| Measure |
MCE+
n=17 participants at risk
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prio
|
MCE- (Control)
n=17 participants at risk
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergies
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Musculoskeletal and connective tissue disorders
Body aches
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Musculoskeletal and connective tissue disorders
bone fracture
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Gastrointestinal disorders
constipation
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
35.3%
6/17 • Number of events 6 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
35.3%
6/17 • Number of events 6 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Psychiatric disorders
Depression
|
41.2%
7/17 • Number of events 7 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
29.4%
5/17 • Number of events 5 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
4/17 • Number of events 4 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Nervous system disorders
Dizziness
|
41.2%
7/17 • Number of events 7 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
General disorders
Fatigue
|
17.6%
3/17 • Number of events 3 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
General disorders
Fever
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Gastrointestinal disorders
GERD
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Nervous system disorders
Headache, Migraine
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Nervous system disorders
Headache, Non-migraine
|
41.2%
7/17 • Number of events 7 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
41.2%
7/17 • Number of events 7 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Psychiatric disorders
Insomnia
|
41.2%
7/17 • Number of events 7 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
General disorders
Irritability
|
52.9%
9/17 • Number of events 9 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
47.1%
8/17 • Number of events 8 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Psychiatric disorders
Mania
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Reproductive system and breast disorders
Menstrual cramps
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.6%
3/17 • Number of events 3 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
23.5%
4/17 • Number of events 4 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal sinus drainage
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Gastrointestinal disorders
Nausea
|
29.4%
5/17 • Number of events 5 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
41.2%
7/17 • Number of events 7 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Psychiatric disorders
Nightmare
|
35.3%
6/17 • Number of events 6 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Musculoskeletal and connective tissue disorders
Pain, Arthritis
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Musculoskeletal and connective tissue disorders
Pain, Musculoskeletal
|
23.5%
4/17 • Number of events 4 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
23.5%
4/17 • Number of events 4 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Musculoskeletal and connective tissue disorders
Pain, other
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
29.4%
5/17 • Number of events 5 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Cardiac disorders
tachycardia
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Gastrointestinal disorders
vomiting
|
17.6%
3/17 • Number of events 3 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Psychiatric disorders
depressed mood
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Infections and infestations
Ear Problem/Infection
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
General disorders
Edema
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Nervous system disorders
Dental, Teeth
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Gastrointestinal disorders
Pain, GI (abdominal)
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Skin and subcutaneous tissue disorders
Skin Issues, NOS
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Nervous system disorders
Numbness/Tingling
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
General disorders
Vivid Dreams
|
70.6%
12/17 • Number of events 12 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
23.5%
4/17 • Number of events 4 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsilitis
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Social circumstances
Stress
|
23.5%
4/17 • Number of events 4 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Psychiatric disorders
Restlessness
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Skin and subcutaneous tissue disorders
Patch, Itching or burning at patch site
|
52.9%
9/17 • Number of events 9 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
35.3%
6/17 • Number of events 6 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Skin and subcutaneous tissue disorders
Patch, Rash at patch site
|
52.9%
9/17 • Number of events 9 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Increase in Phlegm
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Mouth/throat irritation
|
17.6%
3/17 • Number of events 3 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
|
Renal and urinary disorders
Bacterial Infection
|
0.00%
0/17 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place