Trial Outcomes & Findings for Switching to Potential Reduced Exposure Products in Adult Smokers (NCT NCT04250727)
NCT ID: NCT04250727
Last Updated: 2024-05-01
Results Overview
The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
up to week 4
Results posted on
2024-05-01
Participant Flow
Participant milestones
| Measure |
3mg Nicotine Concentration
15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
6mg Nicotine Concentration
15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Switching to Potential Reduced Exposure Products in Adult Smokers
Baseline characteristics by cohort
| Measure |
3mg Nicotine Concentration
n=15 Participants
15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
6mg Nicotine Concentration
n=15 Participants
15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.20 years
STANDARD_DEVIATION 9.70 • n=99 Participants
|
55.47 years
STANDARD_DEVIATION 13.40 • n=107 Participants
|
56.83 years
STANDARD_DEVIATION 11.60 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race Customized · Black/African American
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race Customized · White/Caucasian
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race Customized · Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Smoke within 30 minutes of waking
Yes
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Smoke within 30 minutes of waking
No
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to week 4The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.
Outcome measures
| Measure |
3mg Nicotine Concentration
n=15 Participants
15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
6mg Nicotine Concentration
n=15 Participants
15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day (Log-transformed)
|
2.0 number of cigarettes smoked
Standard Deviation 0.1
|
1.8 number of cigarettes smoked
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: This will be evaluated at week 4.To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations
Outcome measures
| Measure |
3mg Nicotine Concentration
n=15 Participants
15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
6mg Nicotine Concentration
n=15 Participants
15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
|---|---|---|
|
Number of Participants Who Switched From Cigarettes to the ZYN Pouches.
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to week 4The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations
Outcome measures
| Measure |
3mg Nicotine Concentration
n=15 Participants
15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
6mg Nicotine Concentration
n=15 Participants
15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
|---|---|---|
|
Percentage of Smoke Free Days.
|
8.57 percentage of smoke free days
Standard Deviation 22.42
|
11.22 percentage of smoke free days
Standard Deviation 24.58
|
SECONDARY outcome
Timeframe: baseline and week 4Participants will provide repeated lab samples for biomarker assessments. Urine samples obtained will be compared at baseline and week 4 for differences by group and by time.
Outcome measures
| Measure |
3mg Nicotine Concentration
n=15 Participants
15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
6mg Nicotine Concentration
n=15 Participants
15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
|---|---|---|
|
Level of Biomarker (NNAL) Among Smokers
Week 4
|
18.55 pg/mL
Standard Error 1.94
|
16.04 pg/mL
Standard Error 1.91
|
|
Level of Biomarker (NNAL) Among Smokers
Baseline
|
17.26 pg/mL
Standard Error 1.89
|
15.98 pg/mL
Standard Error 1.89
|
SECONDARY outcome
Timeframe: week 4Population: This measure was not used in the study and therefore data were not collected.
To evaluate the acceptability of switching, participants will also be asked how likely it is that they will continue to use ZYN oral nicotine patches for cigarette substitution compared to cigarettes on a question designed for this trial.
Outcome measures
Outcome data not reported
Adverse Events
3mg Nicotine Concentration
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
6mg Nicotine Concentration
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3mg Nicotine Concentration
n=15 participants at risk
15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
6mg Nicotine Concentration
n=15 participants at risk
15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.
ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
|
|---|---|---|
|
Cardiac disorders
chest pain
|
6.7%
1/15 • Up to 4 weeks
|
6.7%
1/15 • Up to 4 weeks
|
|
Cardiac disorders
rapid heartbeat
|
6.7%
1/15 • Up to 4 weeks
|
20.0%
3/15 • Up to 4 weeks
|
|
Eye disorders
vision problems
|
6.7%
1/15 • Up to 4 weeks
|
6.7%
1/15 • Up to 4 weeks
|
|
Gastrointestinal disorders
abdominal pain
|
26.7%
4/15 • Up to 4 weeks
|
6.7%
1/15 • Up to 4 weeks
|
|
Gastrointestinal disorders
appetite changes
|
20.0%
3/15 • Up to 4 weeks
|
26.7%
4/15 • Up to 4 weeks
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/15 • Up to 4 weeks
|
6.7%
1/15 • Up to 4 weeks
|
|
Gastrointestinal disorders
nausea
|
26.7%
4/15 • Up to 4 weeks
|
40.0%
6/15 • Up to 4 weeks
|
|
Gastrointestinal disorders
vomiting
|
6.7%
1/15 • Up to 4 weeks
|
6.7%
1/15 • Up to 4 weeks
|
|
General disorders
fatigue
|
20.0%
3/15 • Up to 4 weeks
|
40.0%
6/15 • Up to 4 weeks
|
|
General disorders
fever
|
6.7%
1/15 • Up to 4 weeks
|
6.7%
1/15 • Up to 4 weeks
|
|
General disorders
other
|
40.0%
6/15 • Up to 4 weeks
|
53.3%
8/15 • Up to 4 weeks
|
|
Infections and infestations
sore throat
|
33.3%
5/15 • Up to 4 weeks
|
13.3%
2/15 • Up to 4 weeks
|
|
Investigations
weight loss
|
6.7%
1/15 • Up to 4 weeks
|
6.7%
1/15 • Up to 4 weeks
|
|
Nervous system disorders
dizziness
|
0.00%
0/15 • Up to 4 weeks
|
13.3%
2/15 • Up to 4 weeks
|
|
Nervous system disorders
fainting
|
0.00%
0/15 • Up to 4 weeks
|
0.00%
0/15 • Up to 4 weeks
|
|
Nervous system disorders
headache
|
46.7%
7/15 • Up to 4 weeks
|
40.0%
6/15 • Up to 4 weeks
|
|
Psychiatric disorders
vivid dreams
|
13.3%
2/15 • Up to 4 weeks
|
20.0%
3/15 • Up to 4 weeks
|
|
Psychiatric disorders
difficulty sleeping
|
26.7%
4/15 • Up to 4 weeks
|
20.0%
3/15 • Up to 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
33.3%
5/15 • Up to 4 weeks
|
20.0%
3/15 • Up to 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
coughing
|
33.3%
5/15 • Up to 4 weeks
|
33.3%
5/15 • Up to 4 weeks
|
|
Skin and subcutaneous tissue disorders
itching or rash
|
6.7%
1/15 • Up to 4 weeks
|
0.00%
0/15 • Up to 4 weeks
|
|
Skin and subcutaneous tissue disorders
sweating
|
6.7%
1/15 • Up to 4 weeks
|
26.7%
4/15 • Up to 4 weeks
|
Additional Information
Lisa Fucito, PhD: Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry
Yale School of Medicine
Phone: (203) 688-1878
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place