Clinical Trials Logo
  1. Home
  2. Nicotine Addiction
  3. NCT02870218

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

Cigarette Smoking Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02870218
Study type Interventional
Source Rose Research Center, LLC
Contact
Status Completed
Phase Phase 2
Start date May 1, 2019
Completion date July 28, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Active, not recruiting NCT02643914 - Control Systems Approach to Predicting Individualized Dynamics of Nicotine Cravings N/A
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A
Active, not recruiting NCT02629679 - Sports, Education and Consumption of Substances in Adolescents N/A
Completed NCT02385227 - Characterization of Biomarkers of Tobacco Exposure, Urge-to-Smoke Following Exclusive and Dual Ad Lib Use of Electronic Cigarettes N/A
Completed NCT02218281 - Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation N/A
Completed NCT01199380 - Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms Phase 2
Completed NCT00756704 - The Effectiveness of Smoking Cessation Guidelines in the Emergency Department N/A
Completed NCT01081119 - Brief Voluntary Alcohol and Drug Intervention for Middle School Youth Phase 2
Completed NCT01692353 - Cardiovascular Disease Biomarkers in Smokers and Moist Snuff Consumers N/A
Completed NCT00802919 - Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors Phase 4
Completed NCT00682474 - School Nurse-Delivered Smoking Cessation Intervention Phase 2/Phase 3
Completed NCT05520775 - Semaglutide for Alcohol Use Disorder Phase 2
Completed NCT03743532 - E-Cigarettes and Financial Incentives to Promote Tobacco Harm Reduction Among Adults Accessing Shelter Services N/A
Terminated NCT03840694 - Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior N/A
Completed NCT06032793 - Effects of Deep Breathing Exercise on Pulmonary Function, Perceived Stress and Physical Fitness. N/A
Terminated NCT03326128 - High Dose Bupropion for Smoking Cessation - Pilot Study Phase 2
Recruiting NCT03218670 - Your Health in On Click N/A
Completed NCT02538042 - Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue) N/A