Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Nicotine Dependence
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Single blind, placebo-controlled, mixed-design with nicotine delivery as a within-subjects factor.Masking: Single (Participant)Masking Description: Participant will not know nicotine dose or rate of infusion.Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 35 years
Gender
Both males and females

Description

A placebo-controlled study that will enroll male and female tobacco smokers menthol (n=35) and non-menthol (n=35) to participate in five experimental sessions. During the experimental session, subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion...

A placebo-controlled study that will enroll male and female tobacco smokers menthol (n=35) and non-menthol (n=35) to participate in five experimental sessions. During the experimental session, 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). The infusion conditions for each experimental session will be determined in random order. Aim 1 is to establish a dose-effect curve for positive subjective effects (drug liking and good drug effects) and alleviation of smoking urges, as a function of nicotine delivery rate in menthol and non-menthol cigarette preferring smokers Aim 2 is to establish a dose-effect curve positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate. Aim 3 is to establish a dose-effect curve for nicotine's effect to alleviate symptoms of nicotine withdrawal in abstinent smokers as a function of nicotine delivery rate. Aim 4 is to establish a dose-effect curve for nicotine's acute cardiovascular health effects. Data from this project will help to establish benchmark values for nicotine's threshold effects that will guide policies on the nicotine yield of tobacco products.

Tracking Information

NCT #
NCT03580525
Collaborators
Not Provided
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D.,Ph.D. Professor of Psychiatry