NCT02870218

Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Rose Research Center, LLC · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Three hundred-twenty (320) adult smokers of menthol or non-menthol combustible cigarettes will be recruited and randomly assigned to one of five groups (n=64/group), who will be asked to switch for 12 weeks to ad libitum use of combustible cigarettes (matched to subjects' menthol preference) containing either 0.4, 1.4, 2.5, 5.6 or 16.9 mg nicotine (standardized nicotine yields ranging from 0.02-0.80 mg/cigarette), respectively. Each group will include 32 heavy (≥ 20 cigarettes/day), and 32 light smokers (≤10 cigarettes/day), who are hypothesized to be more sensitive to nicotine's reinforcing effects. Participants will also have free access to nicotine-containing e-cigarettes (JUUL) throughout the 12-week period. Abuse liability of combustible cigarettes will be assessed by behavioral (cigarettes/day, time to first cigarettes), self-report (rewarding effects, withdrawal symptoms) and biochemical indices (expired air carbon monoxide, cotinine blood sampling). In laboratory sessions, we will measure nicotine thresholds for detecting and recognizing the addictive, rewarding effects of smoking. This study is designed to help the FDA identify a target nicotine threshold that will not attract young people to smoking or induce relapse in former smokers. Additionally, we will determine the level of cigarette nicotine reduction that will be tolerated without inducing dissatisfaction in smokers, information that is relevant to the FDA for designing a stepwise nicotine reduction policy that can be implemented without widespread objections. The knowledge gained from this project will greatly increase our knowledge of nicotine addiction and will help frame an FDA policy relating to the regulation of the nicotine content of tobacco. Ultimately, a well-designed nicotine reduction policy has the potential to greatly reduce the enormous toll of death and disease caused by cigarette smoking.

Conditions

• Nicotine Addiction
• Cigarette Smoking

Interventions

Type	Name	Description
DRUG	Smoking research cigarettes with e-cigarette	Smoking research cigarettes with varying levels of nicotine with unlimited access to 15 mg/ml nicotine-containing e-cigarettes.
DRUG	Nicotine discrimination thresholds	Measure of nicotine thresholds for detecting and recognizing the addictive, rewarding effects of smoking.

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-07-28
• Completion: 2021-07-28
• First posted: 2016-08-17
• Last updated: 2022-01-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study