Trial Outcomes & Findings for The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users (NCT NCT02102100)

Last Updated: 2020-03-19

Results Overview

The Drug Effects Questionnaire (DEQ) is used in studies of acute subjective response (SR) to a variety of substances. The DEQ consists of 11 questions: cooling effect, dislike the sensation, any sensations, feel a drug effect, high, feel stimulated, feel a head rush, like drug effect, dislike any effects, craving a cigarette, and like more of the drug. To calculate the DEQ- 'Good Drug Effects', peak values from post-infusion time points were calculated for the change in the intensity of positive subjective effects as measured with 2 DEQ questions - DEQ question #6 'like drug effect' and DEQ question #11 'would like more of the drug'. Each question was measured on a scale with a minimum score of 0 and a maximum score of 100.The peak values for "like" and " I want more" were averaged to obtain a summary score to represent the feel 'Good Drug Effects' composite factor. DEQ measures were skewed and square root transformations were used. Higher scores indicate more positive effects.

Recruitment status

COMPLETED

Study phase

Target enrollment

57 participants

Primary outcome timeframe

up to 55 minutes post-infusion

Results posted on

2020-03-19

Participant Flow

Male and female smokers between the ages of 18 and 30 yrs, with a history of smoking for the past 12 months, at least one cigarette per day.

Participant milestones

Participant milestones
Measure	Menthol-Preferring Smokers Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25mg and 0.5mg/70kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.	Non-Methol Preferring Smokers Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25mg and 0.5mg/70kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.
Overall Study STARTED	32	25
Overall Study COMPLETED	23	18
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Menthol-Preferring Smokers n=32 Participants Menthol smokers randomized to a test session order and received control menthol (0.0% + tobacco flavor), low menthol (0.5% + tobacco flavor), and high menthol (3.2% + tobacco flavor) by standardized inhalation from an e-cigarette just prior to each nicotine infusion (a single menthol condition for each test session). Within each test session, all three IV nicotine conditions were tested, 1 hour apart, by delivering saline, nicotine at 0.25 mg nicotine/70 kg and nicotine at 0.5 mg nicotine/70 kg, in a random order, just after last inhalation. For each participant, the randomized nicotine infusion sequence was fixed across the three test sessions, each performed at least 24 hours apart.	Non-Menthol-Preferring Smokers n=25 Participants Non-menthol smokers randomized to a test session order and received control menthol (0.0% + tobacco flavor), low menthol (0.5% + tobacco flavor), and high menthol (3.2% + tobacco flavor) by standardized inhalation from an e-cigarette just prior to each nicotine infusion (a single menthol condition for each test session). Within each test session, all three IV nicotine conditions were tested, 1 hour apart, by delivering saline, nicotine at 0.25 mg nicotine/70 kg and nicotine at 0.5 mg nicotine/70 kg, in a random order, just after last inhalation. For each participant, the randomized nicotine infusion sequence was fixed across the three test sessions, each performed at least 24 hours apart.	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	25 Participants n=7 Participants	57 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24.2 years STANDARD_DEVIATION 3.6 • n=5 Participants	24.0 years STANDARD_DEVIATION 3.6 • n=7 Participants	24.1 years STANDARD_DEVIATION 3.6 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	25 participants n=7 Participants	57 participants n=5 Participants
Nicotine Metabolite Ratio	0.29 ratio STANDARD_DEVIATION 0.19 • n=5 Participants	0.55 ratio STANDARD_DEVIATION 0.35 • n=7 Participants	0.40 ratio STANDARD_DEVIATION .30 • n=5 Participants

PRIMARY outcome

Timeframe: up to 55 minutes post-infusion

Outcome measures

Outcome measures
Measure	Menthol-Preferring Smokers n=32 Participants Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session. nicotine: In each of 3 test sessions, subjects in each arm will receive a randomized sequence of three intravenous infusions (30 sec each), one hour apart. The infusions will consist of saline, nicotine (.25 mg / 70kg) and nicotine (0.5 mg / 70 kg). The randomized sequence will remain the same between test sessions for a given subject. menthol: In each of 3 test sessions, subjects will take 6 inhalations from the study e-cigarette, one inhalation every 15 seconds, of the randomized menthol condition for that test session ust prior to each intravenous infusion. The menthol conditions are: 3.2% menthol, 0	Non-Menthol Preferring Smokers n=25 Participants Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session. nicotine: In each of 3 test sessions, subjects in each arm will receive a randomized sequence of three intravenous infusions (30 sec each), one hour apart. The infusions will consist of saline, nicotine (.25 mg / 70kg) and nicotine (0.5 mg / 70 kg). The randomized sequence will remain the same between test sessions for a given subject. menthol: In each of 3 test sessions, subjects will take 6 inhalations from the study e-cigarette, one inhalation every 15 seconds, of the randomized menthol condition for that test session ust prior to each intravenous infusion. The menthol conditions are: 3.2% menthol, 0
Drug Effects Questionnaire (DEQ)- 'Good Drug Effects' Across Conditions (main effect)	5.1979 scores on a scale Standard Error 0.3803	6.8384 scores on a scale Standard Error 0.4292
Drug Effects Questionnaire (DEQ)- 'Good Drug Effects' High Menthol w High Nicotine	5.6235 scores on a scale Standard Error 0.4731	7.6285 scores on a scale Standard Error 0.5287
Drug Effects Questionnaire (DEQ)- 'Good Drug Effects' High Menthol w Low Nicotine	5.226 scores on a scale Standard Error 0.4766	7.4351 scores on a scale Standard Error 0.5302
Drug Effects Questionnaire (DEQ)- 'Good Drug Effects' High Menthol w Saline	5.0699 scores on a scale Standard Error 0.4768	7.6285 scores on a scale Standard Error 0.5287
Drug Effects Questionnaire (DEQ)- 'Good Drug Effects' Low Menthol w High Nicotine	5.8971 scores on a scale Standard Error 0.4736	7.5808 scores on a scale Standard Error 0.5346
Drug Effects Questionnaire (DEQ)- 'Good Drug Effects' Low Menthol w Low Nicotine	5.5481 scores on a scale Standard Error 0.4809	6.7656 scores on a scale Standard Error 0.5363
Drug Effects Questionnaire (DEQ)- 'Good Drug Effects' Low Menthol w Saline	4.4655 scores on a scale Standard Error 0.4741	6.3960 scores on a scale Standard Error 0.5307

Adverse Events

Menthol-Preferring Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Menthol Preferring Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mehmet Sofuoglu, M.D.,Ph.D.

Yale University

Phone: 203-932-5711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place