Trial Outcomes & Findings for Nicotine's Potential Abuse With Menthol (NCT NCT04535362)
NCT ID: NCT04535362
Last Updated: 2024-08-26
Results Overview
Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on the subscales range from 0 - 100 where 0 is the measure of least impactful 'effect'.
COMPLETED
EARLY_PHASE1
16 participants
Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes
2024-08-26
Participant Flow
Participant milestones
| Measure |
Menthol FIRST, Non-Menthol SECOND
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
Non-Menthol FIRST, Menthol SECOND
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
Entered Phase 1
|
8
|
8
|
|
Overall Study
Completed Phase 1
|
8
|
8
|
|
Overall Study
Entered Phase 2
|
8
|
8
|
|
Overall Study
Completed Phase 2
|
5
|
7
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Menthol FIRST, Non-Menthol SECOND
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
Non-Menthol FIRST, Menthol SECOND
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Nicotine's Potential Abuse With Menthol
Baseline characteristics by cohort
| Measure |
Study Participants
n=16 Participants
All participants in the study prior to randomization to crossover order. Eligible participants were individuals who reported smoking at least 5 cigarettes a day for the past year and had urine cotinine levels exceeding 100 ng/mL, an indicator of daily smoking. Participants were not interested in quitting smoking and were free of major medical and psychiatric disorders, including substance use disorders (except tobacco use), as confirmed by medical and psychiatric assessment.
|
|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
|
Average number of cigarettes consumed daily
|
10.5 cigarettes per day
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence (FTND)
|
4.2 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutesPopulation: Participants assessed an any or both points in the crossover design.
Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on the subscales range from 0 - 100 where 0 is the measure of least impactful 'effect'.
Outcome measures
| Measure |
Menthol
n=16 Participants
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
Non-Menthol
n=13 Participants
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
|---|---|---|
|
Drug Effect Questionnaire - Stimulatory Effects
2.5 Minutes
|
39.37 units on a scale
Standard Deviation 24.41
|
33.48 units on a scale
Standard Deviation 19.73
|
|
Drug Effect Questionnaire - Stimulatory Effects
5 minutes
|
32.35 units on a scale
Standard Deviation 27.93
|
33.23 units on a scale
Standard Deviation 28.79
|
|
Drug Effect Questionnaire - Stimulatory Effects
10 minutes
|
13.19 units on a scale
Standard Deviation 16.15
|
19.43 units on a scale
Standard Deviation 21.41
|
PRIMARY outcome
Timeframe: Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutesPopulation: Participants assessed an any or both points in the crossover design.
Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting: 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on the subscales range from 0 - 100 where 0 is the measure of least impactful 'effect'.
Outcome measures
| Measure |
Menthol
n=16 Participants
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
Non-Menthol
n=13 Participants
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
|---|---|---|
|
Drug Effect Questionnaire - Pleasure Effect
2.5 minutes
|
37.51 units on a scale
Standard Deviation 28.35
|
27.25 units on a scale
Standard Deviation 17.62
|
|
Drug Effect Questionnaire - Pleasure Effect
5 minutes
|
36.49 units on a scale
Standard Deviation 31.55
|
29.28 units on a scale
Standard Deviation 25.42
|
|
Drug Effect Questionnaire - Pleasure Effect
10 minutes
|
23.42 units on a scale
Standard Deviation 20.80
|
24.71 units on a scale
Standard Deviation 18.37
|
PRIMARY outcome
Timeframe: Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutesPopulation: Participants assessed an any or both points in the crossover design.
Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting: 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on the subscales range from 0 - 100 where 0 is the measure of least impactful 'effect'.
Outcome measures
| Measure |
Menthol
n=16 Participants
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
Non-Menthol
n=13 Participants
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
|---|---|---|
|
Drug Effect Questionnaire - Aversive Effect
2.5 minutes
|
11.33 units on a scale
Standard Deviation 11.78
|
14.76 units on a scale
Standard Deviation 15.56
|
|
Drug Effect Questionnaire - Aversive Effect
5 minutes
|
8.73 units on a scale
Standard Deviation 11.12
|
11.23 units on a scale
Standard Deviation 13.78
|
|
Drug Effect Questionnaire - Aversive Effect
10 minutes
|
6.33 units on a scale
Standard Deviation 8.50
|
6.92 units on a scale
Standard Deviation 8.79
|
PRIMARY outcome
Timeframe: Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutesPopulation: Participants assessed an any or both points in the crossover design.
Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting: 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on all subscales, including Head Rush scale, range from 0 - 100 where lower scores indicate less head rush.
Outcome measures
| Measure |
Menthol
n=16 Participants
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
Non-Menthol
n=13 Participants
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
|
|---|---|---|
|
Drug Effect Questionnaire - Head Rush
2.5 minutes
|
31.73 units on a scale
Standard Deviation 32.55
|
14.76 units on a scale
Standard Deviation 15.56
|
|
Drug Effect Questionnaire - Head Rush
5 minutes
|
19.20 units on a scale
Standard Deviation 25.48
|
11.23 units on a scale
Standard Deviation 13.78
|
|
Drug Effect Questionnaire - Head Rush
10 minutes
|
8.93 units on a scale
Standard Deviation 13.93
|
6.92 units on a scale
Standard Deviation 8.79
|
SECONDARY outcome
Timeframe: up to one yearPopulation: these data were not collected
The SAFTEE is a technique for the systematic assessment of side effects in clinical trials developed by National Institute of Mental Health. It is a questionnaire that rates the current severity of a wide range of somatic, behavioral and affective symptoms in general and specific inquiry formats. It is designed to report adverse health events, regardless of whether or not they are suspected to be drug related, in order to reduce the under-reporting of unanticipated events compared with "known or expected" events.
Outcome measures
Outcome data not reported
Adverse Events
Menthol
Non-Menthol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mehmet Sofuoglu, MD, PhD: Professor of Psychiatry; Director of VA New England Mental Illness Researc
Yale School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place