Early Phase 1 N=16 Randomized Single-blind Health Services Research

Nicotine's Potential Abuse With Menthol

Nicotine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT04535362 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Drug Effect Questionnaire - Stimulatory Effects — 39.37; 33.48; 32.35; 33.23 units on a scale — p=0.93

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Nicotine (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Drug Effect Questionnaire - Stimulatory Effects	39.37; 33.48; 32.35; 33.23; 13.19; 19.43	0.93
PRIMARY Drug Effect Questionnaire - Pleasure Effect	37.51; 27.25; 36.49; 29.28; 23.42; 24.71	0.68
PRIMARY Drug Effect Questionnaire - Aversive Effect	11.33; 14.76; 8.73; 11.23; 6.33; 6.92	0.37
PRIMARY Drug Effect Questionnaire - Head Rush	31.73; 14.76; 19.20; 11.23; 8.93; 6.92	0.20
SECONDARY SAFTEE	—	—

Summary

To examine if switching from menthol to non-menthol cigarettes will change the dose-effect curves for positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate in smokers.

Eligibility Criteria

Inclusion Criteria

1) Female and male smokers, aged 21 to 35 years, who have been smoking tobacco cigarettes for at least a year;
2) smoke ≥ 5 and less than 20 cigarettes per day;
3) urine cotinine levels > 100 ng/mL consistent with nicotine intake of an active smoker
4) not seeking treatment at the time of the study for nicotine dependence;
5) in good health as verified by medical history, screening examination, and screening laboratory tests;
6) for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria

1) history of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study;
2) regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics);
3) current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine;
4) use of e-cigarettes more than 10 days in the past 30 days;
5) urine drug screening indicating recent illicit drugs use (with the exception of marijuana).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04535362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.