Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A placebo-controlled study to enroll male and female tobacco smokers menthol (n=35) and non-menthol (n=35) who will participate in five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec).

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

Details

• Lead Sponsor: Yale University
• Treatments: Menthol; Nicotine

Criteria

Inclusion criteria:

• Female and male smokers, aged 18 to 35 years, who have been smoking tobacco cigarettes for at least a year

• Smoke ≥ 5 and less than 20 cigarettes per day;

• Urine cotinine levels > 100 ng/mL consistent with nicotine intake of an active smoker (23)

• Not seeking treatment at the time of the study for nicotine dependence;

• In good health as verified by medical history, screening examination, and screening laboratory tests

• For women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion criteria:

• History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study

• Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)

• Current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine

• Use of e-cigarettes more than 10 days in the past 30 days

• Urine drug screening indicating recent illicit drugs use (with the exception of marijuana).