Nicotine's Potential Abuse With Menthol

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Nicotine

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).