RECRUITING

Cannabis-Tobacco Co-Use Treatment Study

Description

The purpose of the RECLAIM study is to evaluate the effectiveness of varenicline (sometimes known as Chantix) compared to placebo (an inactive substance) for the treatment of cigarettes and cannabis (marijuana). Varenicline is not FDA approved for the combination treatment of cigarette abstinence and cannabis reduction or abstinence. All participants will also receive counseling and access to online treatment modules during a quit attempt for cigarettes and a reduction attempt for cannabis. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed. To qualify, participants must be 18 or older, live in South Carolina, use cigarettes and cannabis, and are interested in quitting cigarettes and reducing cannabis.

Conditions

Tobacco Use DisorderTobacco Use CessationCannabis UseCannabis Use DisorderMarijuana Use
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Related Conditions:

Tobacco Use DisorderTobacco Use CessationCannabis UseCannabis Use DisorderMarijuana Use

Study Overview

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Study Details

Study overview

The purpose of the RECLAIM study is to evaluate the effectiveness of varenicline (sometimes known as Chantix) compared to placebo (an inactive substance) for the treatment of cigarettes and cannabis (marijuana). Varenicline is not FDA approved for the combination treatment of cigarette abstinence and cannabis reduction or abstinence. All participants will also receive counseling and access to online treatment modules during a quit attempt for cigarettes and a reduction attempt for cannabis. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed. To qualify, participants must be 18 or older, live in South Carolina, use cigarettes and cannabis, and are interested in quitting cigarettes and reducing cannabis.

Randomized Controlled Trial of Varenicline to Treat Tobacco and Cannabis Co-Use (RECLAIM)

Cannabis-Tobacco Co-Use Treatment Study

Condition
Tobacco Use Disorder
Intervention / Treatment

-

Contacts and Locations

Charleston

Medical University of South Carolina - Charleston, Charleston, South Carolina, United States, 29403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Ages 18 and over (no upper age limit)
  • 2. Must smoke at least 5 tobacco cigarettes per day on at least 20 out of the past 30 days for the past 3 months
  • 3. Must express interest in quitting tobacco
  • 4. Must express interest in cannabis reduction and/or cessation
  • 5. Must submit a positive instant-read test for cotinine and cannabis prior to enrollment
  • 6. Must self-report cannabis use (THC-dominant products) on at 3 days per week out of the past 30 days
  • 7. Must be willing to take varenicline or placebo for 12 weeks
  • 8. Must reside in South Carolina
  • 1. Any significant or acutely unstable medical, psychiatric, or substance use problem (including clinically significant disorders) that would contraindicate research, interfere with safety, compromise data integrity, or preclude consistent study participation
  • 2. Pregnant or trying to become pregnant
  • 3. Use of medications with smoking cessation efficacy
  • 4. Regular use of e-cigarettes or other tobacco products (\<10 days in the past month)
  • 5. Self-reported use of cannabis exclusively for medical purposes

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Medical University of South Carolina,

Erin Mcclure, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

2029-01-01