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New treatment option for Tobacco Use Disorder
Official title Cannabis-Tobacco Co-Use Treatment Study
ClinicalTrials.gov ID: NCT06883162
What this study is testing
What is Varenicline?
Varenicline is an investigational medicine, given as an once-weekly, being studied as a potential treatment for tobacco use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Ages 18 and over (no upper age limit)
- Must smoke at least 5 tobacco cigarettes per day on at least 20 out of the past 30 days for the past 3 months
- Must express interest in quitting tobacco
- Must express interest in cannabis reduction and/or cessation
- Must submit a positive instant-read test for cotinine and cannabis prior to enrollment
You likely can't join if
- Any significant or acutely unstable medical, psychiatric, or substance use problem (including clinically significant disorders) that would...
- Pregnant or trying to become pregnant
- Use of medications with smoking cessation how well it works
- Regular use of e-cigarettes or other tobacco products (\<10 days in the past month)
See the full eligibility criteria
- Ages 18 and over (no upper age limit)
- Must smoke at least 5 tobacco cigarettes per day on at least 20 out of the past 30 days for the past 3 months
- Must express interest in quitting tobacco
- Must express interest in cannabis reduction and/or cessation
- Must submit a positive instant-read test for cotinine and cannabis prior to enrollment
- Must self-report cannabis use (THC-dominant products) on at 3 days per week out of the past 30 days
- Must be willing to take varenicline or placebo for 12 weeks
- Must reside in South Carolina
- 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...
- Pregnant or trying to become pregnant
- Use of medications with smoking cessation how well it works
- Regular use of e-cigarettes or other tobacco products (\<10 days in the past month)
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.