Tobacco Use DisorderPhase 3RECLAIMNCT06883162
Cannabis-Tobacco Co-Use Treatment Study
A Phase 3 study testing Varenicline, Counseling and Psychosocial modules in people with Tobacco Use Disorder and Tobacco Use Cessation, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Tobacco Use Cessation, Cannabis Use
- What is being tested?
- Varenicline, Counseling and Psychosocial modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2025to 1 Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Pregnant or trying to become pregnant
- Use of medications with smoking cessation efficacy
- Regular use of e-cigarettes or other tobacco products (<10 days in the past month)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina - Charleston
Charleston, South Carolina, 29403
Elizabeth Chapman, 864-898-2992, chapmanb@musc.edu
Ela Williams, williela@musc.edu
About this study
Official title: Randomized Controlled Trial of Varenicline to Treat Tobacco and Cannabis Co-Use (RECLAIM)
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.
Read the detailed description
Tobacco-cannabis co-use results in established harms, yet there are currently no recommended treatment strategies for co-use. The scientific premise of this proposal is based on work conducted by our group demonstrating that: 1) cannabis co-use adversely impacts cigarette abstinence and those co-using cannabis have nearly double the odds of tobacco treatment failure, 2) varenicline may be efficacious in treating CUD, and 3) cannabis reduction (vs. abstinence) may be a potentially more appealing treatment goal. Therefore, this project proposes to evaluate varenicline versus placebo on cigarette abstinence and cannabis use reduction or abstinence among adults who co-use. To bolster outcomes, both groups will receive an evidence-based psychosocial intervention that includes real-time and asynchronously delivered content (all delivered virtually), that leverages the co-use intervention used by Budney (Consultant) as well brief weekly counseling and check-in sessions that we have used in previous and ongoing studies. Asynchronous content (web-based modules) is standardized and through a tailored approach to counseling, the intervention will allow for participant preference for cannabis reduction or abstinence. The selection of this combination treatment for tobacco-cannabis co-use is based on rigorous prior research demonstrating: 1) efficacy of varenicline for tobacco cessation, 2) preliminary efficacy of varenicline for cannabis use, and 3) acceptable, psychosocial co-use treatment modules that have the potential to augment a robust pharmacotherapy to improve outcomes.
Investigators propose a completely remote 12-week treatment trial among adults in South Carolina (ages 18+; N=200) who co-use cigarettes and cannabis regularly. Participants will be included who smoke cigarettes daily or near daily (20+ days in the past 30) and have used cannabis at least 3 times per week in the past month. Participants will be randomized 1:1 to varenicline or placebo and all participants will receive the platform psychosocial intervention. The aims of the study are to: 1) evaluate rates of 7-day biochemically confirmed point prevalence abstinence (PPA) from cigarettes at the 12-week EOT visit comparing varenicline + psychosocial intervention to the placebo + psychosocial intervention participants (Aim 1), 2) compare cannabis use frequency and amount between varenicline and placebo groups during treatment (Weeks 1-12; Aim 2), and 3) explore differential treatment outcomes among male vs. female participants (Exploratory Aim).
- Conditions
- Tobacco Use Disorder, Tobacco Use Cessation, Cannabis Use, Cannabis Use Disorder, Marijuana Use
- Being tested
- Varenicline, Counseling, Psychosocial modules
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use Cessation, Marijuana Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Participants will be randomized 1:1 to varenicline or matched placebo. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1 mg b.i.d. starting on Day 8. Dosing of 2 mg per day will be maintained for the next 11 weeks.
CounselingBehavioural
Research staff will provide skills-based counseling at weekly visits. Weekly counseling sessions will include discussion of online intervention modules, while providing skills-based strategies focused on enlisting social support, recognizing triggers, managing craving/withdrawal/stress, etc. Staff will use motivational enhancement techniques to address tobacco cessation, cannabis reduction or abstinence, and medication adherence.
Psychosocial modulesBehavioural
Participants will have access to online modules addressing tobacco and cannabis co-use to support cessation and/or reduction. Content includes 12 virtual modules combining cognitive behavioral therapy (CBT) and motivational enhancement (MET) to address tobacco, cannabis, and their co-use.
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | Participants will be randomized 1:1 to varenicline or matched placebo. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1 mg b.i.d. starting on Day 8. Dosing of 2 mg per day will be maintained for the next 11 weeks. Receives: Drug: Varenicline; Behavioral: Counseling; Behavioral: Psychosocial modules |
| Placebo | Placebo comparator | Participants will be randomized 1:1 to varenicline or matched placebo. Receives: Behavioral: Counseling; Behavioral: Psychosocial modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette abstinence
Biochemically-confirmed 7-day point prevalence abstinence from tobacco
Measured: Final 7 days of treatment (Week 11 through Week 12)
Secondary outcomes (2)
Changes in cannabis use frequency
Assess changes in cannabis using days (frequency) during treatment
Measured: Weeks 1 through 12 of treatment
Changes in cannabis use amount
Assess changes in sessions (episodes) of cannabis use per day (amount) during treatment
Measured: Weeks 1 through 12 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start6 May 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Erin McClure, Medical University of South Carolina
- Investigators
- Erin Mcclure, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883162
- Sponsor's protocol ID
- Pro00136115
- Other IDs
- R01CA290842
- Acronym
- RECLAIM
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A final de-identified data set will be made available for retrieval and analysis of secondary outcomes, upon request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Varenicline to Treat Tobacco and Cannabis Co-Use (RECLAIM)
- ClinicalTrials.gov ID
- NCT06883162
- Acronym / sponsor ID
- RECLAIM / Pro00136115
- Conditions
- Tobacco Use Disorder, Tobacco Use Cessation, Cannabis Use, Cannabis Use Disorder, Marijuana Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tobacco-cannabis co-use results in established harms, yet there are currently no recommended treatment strategies for co-use. The scientific premise of this proposal is based on work conducted by our group demonstrating that: 1) cannabis co-use adversely impacts cigarette abstinence and those co-using cannabis have nearly double the odds of tobacco treatment failure, 2) varenicline may be efficacious in treating CUD, and 3) cannabis reduction (vs. abstinence) may be a potentially more appealing treatment goal. Therefore, this project proposes to evaluate varenicline versus placebo on cigarette abstinence and cannabis use reduction or abstinence among adults who co-use. To bolster outcomes, both groups will receive an evidence-based psychosocial intervention that includes real-time and asynchronously delivered content (all delivered virtually), that leverages the co-use intervention used by Budney (Consultant) as well brief weekly counseling and check-in sessions that we have used in previous and ongoing studies. Asynchronous content (web-based modules) is standardized and through a tailored approach to counseling, the intervention will allow for participant preference for cannabis reduction or abstinence. The selection of this combination treatment for tobacco-cannabis co-use is based on rigorous prior research demonstrating: 1) efficacy of varenicline for tobacco cessation, 2) preliminary efficacy of varenicline for cannabis use, and 3) acceptable, psychosocial co-use treatment modules that have the potential to augment a robust pharmacotherapy to improve outcomes.
Investigators propose a completely remote 12-week treatment trial among adults in South Carolina (ages 18+; N=200) who co-use cigarettes and cannabis regularly. Participants will be included who smoke cigarettes daily or near daily (20+ days in the past 30) and have used cannabis at least 3 times per week in the past month. Participants will be randomized 1:1 to varenicline or placebo and all participants will receive the platform psychosocial intervention. The aims of the study are to: 1) evaluate rates of 7-day biochemically confirmed point prevalence abstinence (PPA) from cigarettes at the 12-week EOT visit comparing varenicline + psychosocial intervention to the placebo + psychosocial intervention participants (Aim 1), 2) compare cannabis use frequency and amount between varenicline and placebo groups during treatment (Weeks 1-12; Aim 2), and 3) explore differential treatment outcomes among male vs. female participants (Exploratory Aim).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: Varenicline, Behavioral: Counseling, Behavioral: Psychosocial modulesParticipants will be randomized 1:1 to varenicline or matched placebo. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1 mg b.i.d. starting on Day 8. Dosing of 2 mg per day will be maintained for the next 11 weeks. |
| Placebo | Placebo comparator | Behavioral: Counseling, Behavioral: Psychosocial modulesParticipants will be randomized 1:1 to varenicline or matched placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- Pregnant or trying to become pregnant
- Use of medications with smoking cessation efficacy
- Regular use of e-cigarettes or other tobacco products (<10 days in the past month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineParticipants will be randomized 1:1 to varenicline or matched placebo. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1 mg b.i.d. starting on Day 8. Dosing of 2 mg per day will be maintained for the next 11 weeks. | Drug | Varenicline |
| CounselingResearch staff will provide skills-based counseling at weekly visits. Weekly counseling sessions will include discussion of online intervention modules, while providing skills-based strategies focused on enlisting social support, recognizing triggers, managing craving/withdrawal/stress, etc. Staff will use motivational enhancement techniques to address tobacco cessation, cannabis reduction or abstinence, and medication adherence. | Behavioural | Placebo, Varenicline |
| Psychosocial modulesParticipants will have access to online modules addressing tobacco and cannabis co-use to support cessation and/or reduction. Content includes 12 virtual modules combining cognitive behavioral therapy (CBT) and motivational enhancement (MET) to address tobacco, cannabis, and their co-use. | Behavioural | Placebo, Varenicline |
Primary outcome
Cigarette abstinence
Time frame: Final 7 days of treatment (Week 11 through Week 12)
Biochemically-confirmed 7-day point prevalence abstinence from tobacco
2 secondary outcomes
Changes in cannabis use frequency
Time frame: Weeks 1 through 12 of treatment
Changes in cannabis use amount
Time frame: Weeks 1 through 12 of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Yes. A final de-identified data set will be made available for retrieval and analysis of secondary outcomes, upon request to the Principal Investigator.
Related trials for Tobacco Use Disorder
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Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Mcclure principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Varenicline, Counseling and Psychosocial modules in people with Tobacco Use Disorder and Tobacco Use Cessation, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Mcclure (843-792-7192, mccluree@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarette abstinence (time frame: Final 7 days of treatment (Week 11 through Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.