Trial Outcomes & Findings for Exenatide Once Weekly for Smoking Cessation (NCT NCT02975297)
NCT ID: NCT02975297
Last Updated: 2021-01-28
Results Overview
COMPLETED
PHASE1/PHASE2
84 participants
6 weeks
2021-01-28
Participant Flow
1 participant in the exenatide arm did not receive exenatide, and 1 participant in the placebo arm did not receive placebo.
Participant milestones
| Measure |
Exenatide Plus NRT Plus Counseling
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
|
Placebo Plus NRT Plus Counseling
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
Placebo: Normal saline.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
34
|
35
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exenatide Once Weekly for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Exenatide Plus NRT Plus Counseling
n=41 Participants
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
|
Placebo Plus NRT Plus Counseling
n=41 Participants
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
Placebo: Normal saline.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
51.2 years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
51.1 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Marital Status
Never Married
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Marital Status
Divorced/Separated
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Marital Status
Married
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Marital Status
Widowed
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Highest Level of Education
8th Grade or Less
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Highest Level of Education
High School
|
27 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Highest Level of Education
College Degree
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Highest Level of Education
Graduate Degree
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Household Income
<$19,999
|
23 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Household Income
$20,000-39,999
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Household Income
$40,000-59,999
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Household Income
$60,000-79,999
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Household Income
$80,000-99,999
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Household Income
>$100,000
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Household Income
Not reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Cigarettes Smoked per Day
|
18.5 Cigarettes Smoked per Day
STANDARD_DEVIATION 8.7 • n=99 Participants
|
18.4 Cigarettes Smoked per Day
STANDARD_DEVIATION 9.3 • n=107 Participants
|
18.4 Cigarettes Smoked per Day
STANDARD_DEVIATION 8.9 • n=206 Participants
|
|
Years of Regular Smoking
|
27.4 years
STANDARD_DEVIATION 11 • n=99 Participants
|
26.6 years
STANDARD_DEVIATION 12.7 • n=107 Participants
|
27.0 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
|
Nicotine Dependence as Assessed by the Fagerstrom Test for Nicotine Dependence (FTND)
|
6.3 score on a scale
STANDARD_DEVIATION 1.9 • n=99 Participants
|
6 score on a scale
STANDARD_DEVIATION 2.5 • n=107 Participants
|
6.2 score on a scale
STANDARD_DEVIATION 2.2 • n=206 Participants
|
|
Positive Affect as Assessed by the Positive and Negative Affect Schedule (PANAS)
|
35.9 score on a scale
STANDARD_DEVIATION 10.1 • n=99 Participants
|
32.5 score on a scale
STANDARD_DEVIATION 9.8 • n=107 Participants
|
34.2 score on a scale
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Negative Affect as Assessed by the Positive and Negative Affect Schedule (PANAS)
|
18.6 score on a scale
STANDARD_DEVIATION 7.6 • n=99 Participants
|
20.1 score on a scale
STANDARD_DEVIATION 8.0 • n=107 Participants
|
19.3 score on a scale
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-8)
|
8.3 score on a scale
STANDARD_DEVIATION 6.4 • n=99 Participants
|
8.6 score on a scale
STANDARD_DEVIATION 5.9 • n=107 Participants
|
8.5 score on a scale
STANDARD_DEVIATION 6.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
Exenatide Plus NRT Plus Counseling
n=41 Participants
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
|
Placebo Plus NRT Plus Counseling
n=41 Participants
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
Placebo: Normal saline.
|
|---|---|---|
|
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
|
19 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Data were not collected for 7 participants in the Exenatide plus NRT plus counseling arm and 6 participants in the Placebo plus NRT plus counseling arm. Overall Number of Participants Analyzed reflects participants who completed the study visit.
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Outcome measures
| Measure |
Exenatide Plus NRT Plus Counseling
n=34 Participants
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
|
Placebo Plus NRT Plus Counseling
n=35 Participants
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
Placebo: Normal saline.
|
|---|---|---|
|
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
|
17.2 score on a scale
Standard Deviation 11.0
|
16.9 score on a scale
Standard Deviation 9.75
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Data were not collected for 7 participants in the Exenatide plus NRT plus counseling arm and 6 participants in the Placebo plus NRT plus counseling arm. Overall Number of Participants Analyzed reflects participants who completed the study visit.
The Wisconsin Smoking Withdrawal Scale is a 28-item questionnaire designed to assess different aspects of the smoking withdrawal syndrome. Participants rate each item on a Likert scale from zero (strongly disagree) to four (strongly agree). Total score ranges from 0 to 112, with a higher score indicating greater withdrawal.
Outcome measures
| Measure |
Exenatide Plus NRT Plus Counseling
n=34 Participants
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
|
Placebo Plus NRT Plus Counseling
n=35 Participants
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
Placebo: Normal saline.
|
|---|---|---|
|
Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale
|
40.5 score on a scale
Standard Deviation 18.3
|
44.5 score on a scale
Standard Deviation 18.0
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Virtual reality exposure was not done due to transfer of the study to a different site; therefore, data for this outcome measure were not collected.
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 weeksPopulation: Virtual reality exposure was not done due to transfer of the study to a different site; therefore, data for this outcome measure were not collected.
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 weeks (1 week after end of treatment)Population: Data were not collected for 22 participants in the Exenatide plus NRT plus counseling arm and 30 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects the number of participants who were abstinent \[self-reported and verified by expired carbon monoxide (CO) levels (CO≤5 ppm)\] at 6 weeks (end of treatment).
Outcome measures
| Measure |
Exenatide Plus NRT Plus Counseling
n=19 Participants
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
|
Placebo Plus NRT Plus Counseling
n=11 Participants
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
Placebo: Normal saline.
|
|---|---|---|
|
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
|
15 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 10 weeks (4 weeks after end of treatment)Population: Data were not collected for 22 participants in the Exenatide plus NRT plus counseling arm and 30 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects the number of participants who were abstinent \[self-reported and verified by expired carbon monoxide (CO) levels (CO≤5 ppm)\] at 6 weeks (end of treatment).
Outcome measures
| Measure |
Exenatide Plus NRT Plus Counseling
n=19 Participants
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
|
Placebo Plus NRT Plus Counseling
n=11 Participants
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
Placebo: Normal saline.
|
|---|---|---|
|
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 7 weeks (1 week after end of treatment)Population: Data were not collected for 25 participants in the Exenatide plus NRT plus counseling arm and 32 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects those who completed the study visit.
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Outcome measures
| Measure |
Exenatide Plus NRT Plus Counseling
n=16 Participants
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
|
Placebo Plus NRT Plus Counseling
n=9 Participants
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
Placebo: Normal saline.
|
|---|---|---|
|
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
|
13.3 score on a scale
Standard Deviation 7.86
|
14.2 score on a scale
Standard Deviation 8.47
|
SECONDARY outcome
Timeframe: 10 weeks (4 weeks after end of treatment)Population: Data were not collected for 30 participants in the Exenatide plus NRT plus counseling arm and 37 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects those who completed the study visit.
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Outcome measures
| Measure |
Exenatide Plus NRT Plus Counseling
n=11 Participants
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
|
Placebo Plus NRT Plus Counseling
n=4 Participants
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
Placebo: Normal saline.
|
|---|---|---|
|
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
|
11.5 score on a scale
Standard Deviation 5.13
|
11.2 score on a scale
Standard Deviation 2.5
|
Adverse Events
Exenatide Plus NRT Plus Counseling
Placebo Plus NRT Plus Counseling
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exenatide Plus NRT Plus Counseling
n=41 participants at risk
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
|
Placebo Plus NRT Plus Counseling
n=41 participants at risk
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
Placebo: Normal saline.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection site nodule
|
9.8%
4/41 • Number of events 4 • 10 weeks
|
0.00%
0/41 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus at the site of nicotine patch application
|
0.00%
0/41 • 10 weeks
|
2.4%
1/41 • Number of events 1 • 10 weeks
|
Additional Information
Luba Yammine, PhD, APRN, FNP-C, Associate Professor
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place