Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to better understand tobacco outcomes using a well-known stop smoking medication, varenicline, and financial incentives with tobacco users. The investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive tobacco cessation treatment (varenicline) for 12 weeks. This study will recruit adult tobacco users (ages 18-40) who are motivated to quit smoking cigarettes.


Clinical Trial Description

Cannabis co-use among tobacco users is exceedingly common and rates of co-use appear to be increasing among adults in the US, which is consistent with overall increases in cannabis use rates among US adults. Given the current cannabis landscape, further increases in cannabis use are likely and may result in continued increases in the co-use of cannabis and tobacco. Despite high rates of co-use, there is little consensus regarding treatment recommendations for this population and an understanding of the impact of co-use on successful cessation. The literature on the impact of co-use on tobacco cessation outcomes specifically has been mixed and fraught with limitations, including methodological variation, lack of biochemical verification to confirm cannabis use status and severity, and variations in study samples. Currently, no prospective studies have been conducted to evaluate the impact of cannabis use on tobacco cessation outcomes. Further, no studies have collected cannabis use changes during tobacco cessation treatment to assess for concurrent reductions, abstinence, or of greater concern, compensatory (i.e., increased) use as a result of tobacco reduction/abstinence. This study is a prospective 12-week tobacco cessation trial using established methods and outcomes typical of tobacco cessation trials, but specifically recruiting co-users of cannabis. The aims of this proposed study are to; 1) examine the impact of cannabis co-use on tobacco cessation outcomes among co-users compared to tobacco only participants (Aim #1), 2) among cannabis co-users, assess changes in cannabis use during tobacco treatment (Aim #2), and 3) assess for a dose-dependent impact of cannabis co-use severity on tobacco cessation (Exploratory Aim #1). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04228965
Study type Interventional
Source Medical University of South Carolina
Contact
Status Active, not recruiting
Phase Phase 4
Start date January 28, 2020
Completion date September 26, 2024

See also
  Status Clinical Trial Phase
Withdrawn NCT02432066 - Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions Phase 2
Completed NCT03960138 - Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Completed NCT04646668 - Comparative Abuse Liability Among African American and White Smokers N/A
Completed NCT02560324 - Effect of Ramelteon on Smoking Abstinence Phase 2
Completed NCT02347605 - Medicinal Nicotine for Preventing Cue Induced Craving N/A
Completed NCT01442753 - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth N/A
Completed NCT01570595 - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV Phase 1/Phase 2
Completed NCT01625767 - Tobacco Approach Avoidance Training for Adolescent Smokers-1 Phase 2
Completed NCT01428310 - Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke Phase 1
Terminated NCT01800500 - Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers N/A
Active, not recruiting NCT01539525 - Screening to Augment Referral to Treatment- Project START Phase 2
Completed NCT00967005 - N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers Phase 2
Completed NCT01337817 - A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers Phase 1
Active, not recruiting NCT00751660 - Screening Methods in Finding Lung Cancer Early in Current or Former Smokers N/A
Completed NCT00790569 - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking N/A
Completed NCT00664261 - Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking N/A
Completed NCT01213524 - Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia Phase 2
Completed NCT00218179 - Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1 N/A
Completed NCT00158158 - Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2 Phase 2/Phase 3