Nicotine DependencePhase 4VapeCATNCT06688539
E-cigarette Cessation in Adults Who Co-use Cannabis
A Phase 4 study testing Varenicline Pill, Contingency management and Counseling in people with Nicotine Dependence and Tobacco Use Disorder, run by Medical University of South Carolina at 3 sites in United States.
Trial summary
The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Tobacco Use Disorder
- What is being tested?
- Varenicline Pill, Contingency management and Counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Feb 2025to 1 Jun 2027
- Phase
- Phase 4
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 40 years old
- Use e-cigarettes daily or near daily in the past month
- Must submit a positive instant-read urine cotinine test at screening (≥ 200 ng/ml)
- Be interested in quitting use of e-cigarettes
- Must be willing to take varenicline for the standard 12-week course of treatment
- Self-reported use of cannabis on at least 10 out of the past 30 days or must submit a positive qualitative urinary cannabinoid test at screening (> 50 ng/ml)
Who cannot join
- Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than cannabis or tobacco use disorders) in the past three months that may interfere with study performance
- Use of cigarettes on 10+ days in the past 30
- Currently pregnant or breastfeeding
- Current use of medications with smoking cessation efficacy
- Use of any medications that would interfere with varenicline
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
MUSC Charleston
Charleston, South Carolina, 29425
Ela Williams, 843-497-4092, williela@musc.edu
Erin A McClure, PhD
- Recruiting
MUSC Lancaster
Lancaster, South Carolina, 29720
Elizabeth Chapman, 864-898-2992, chapmanb@musc.edu
- Recruiting
Behavioral Health Services of Pickens County
Pickens, South Carolina, 29671
Elizabeth Chapman, LPC, 864-898-2992, chapmanb@musc.edu
About this study
Official title: A Prospective Trial of Varenicline and Incentives for E-cigarette Cessation in Adults Who Co-use Cannabis
The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. Investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both e-cigarettes and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster in Lancaster, SC.
Read the detailed 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; Specific Aim 1. Compare rates of 7-day biochemically-confirmed e-cigarette abstinence with cigarette abstinence rates from the parent R37 co-use sample (as a historical controls). Specific Aim 2. Assess changes in cannabis use during e-cigarette cessation treatment among the new sample of participants enrolled in this extension.
Specific Aim 3. Assess for a dose-dependent impact of cannabis co-use severity on e-cigarette cessation. Specific Aim 4. Characterize and compare patterns of co-use among the e-cigarette sample to those using cigarettes (parent R37).
- Conditions
- Nicotine Dependence, Tobacco Use Disorder
- Being tested
- Varenicline Pill, Contingency management, Counseling
- Keywords
- e-cigarettes, cannabis, treatment
- Medical subject headings
- Tobacco Use Disorder, Vaping, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline PillDrug
In this study, all participants will be administered active medication for a 12 week treatment period. 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 1.0 mg b.i.d. starting on Day 8. Dosing of 2.0 mg per day will be maintained for the next 11 weeks, for a total of 12 weeks of active treatment for all study participants.
Contingency managementBehavioural
Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on e-cigarette abstinence verified through urinary qualitative cotinine (starting at Week 2). A set amount of $20 per study visit will be delivered based on a negative qualitative urinary cotinine result.
CounselingBehavioural
Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Co-use group | Other | E-cigarette and cannabis co-use group Receives: Drug: Varenicline Pill; Behavioral: Contingency management; Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence tobacco abstinence at the end of treatment (Week 12)
7-day point prevalence abstinence from e-cigarettes at the end of treatment (Week 12) will be assessed via biochemical verification (urinary cotinine; ng/ml) and will be compared to cigarette abstinence rates from the parent study (as historical controls)
Measured: Final 7 days of treatment (Week 12)
Secondary outcomes (2)
Changes in cannabis use during e-cigarette cessation treatment
Cannabis use rates (based on urinary cannabinoids [ng/ml]) during the final 4 weeks of tobacco treatment (Weeks 8-12) will be assessed.
Measured: Final 4 weeks of study treatment (Weeks 8-12)
Cannabis co-use severity on e-cigarette abstinence rates
Assess for a dose-dependent impact of cannabis co-use severity on e-cigarette cessation.
Measured: Final 7 days of treatment (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start19 Feb 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 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 A McClure, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688539
- Sponsor's protocol ID
- Pro00136601
- Other IDs
- R37CA237245
- Acronym
- VapeCAT
- Status last verified
- Jun 2026
- First submitted
- 11 Nov 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available for retrieval and analysis of secondary outcomes, upon request to the Principal Investigator. Study datasets (de-i
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Varenicline and Incentives for E-cigarette Cessation in Adults Who Co-use Cannabis
- ClinicalTrials.gov ID
- NCT06688539
- Acronym / sponsor ID
- VapeCAT / Pro00136601
- Conditions
- Nicotine Dependence, Tobacco Use Disorder
- Keywords
- e-cigarettes, cannabis, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 14 Nov 2024 (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 this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. Investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both e-cigarettes and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster in Lancaster, SC.
Detailed 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; Specific Aim 1. Compare rates of 7-day biochemically-confirmed e-cigarette abstinence with cigarette abstinence rates from the parent R37 co-use sample (as a historical controls). Specific Aim 2. Assess changes in cannabis use during e-cigarette cessation treatment among the new sample of participants enrolled in this extension.
Specific Aim 3. Assess for a dose-dependent impact of cannabis co-use severity on e-cigarette cessation. Specific Aim 4. Characterize and compare patterns of co-use among the e-cigarette sample to those using cigarettes (parent R37).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Co-use group | Other | Drug: Varenicline Pill, Behavioral: Contingency management, Behavioral: CounselingE-cigarette and cannabis co-use group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between the ages of 18 and 40 years old
- Use e-cigarettes daily or near daily in the past month
- Must submit a positive instant-read urine cotinine test at screening (≥ 200 ng/ml)
- Be interested in quitting use of e-cigarettes
- Must be willing to take varenicline for the standard 12-week course of treatment
Key exclusion criteria (5 listed)
- Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than cannabis or tobacco use disorders) in the past three months that may interfere with study performance
- Use of cigarettes on 10+ days in the past 30
- Currently pregnant or breastfeeding
- Current use of medications with smoking cessation efficacy
- Use of any medications that would interfere with varenicline
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 |
|---|---|---|
| Varenicline PillIn this study, all participants will be administered active medication for a 12 week treatment period. 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 1.0 mg b.i.d. starting on Day 8. Dosing of 2.0 mg per day will be maintained for the next 11 weeks, for a total of 12 weeks of active treatment for all study participants. | Drug | Co-use group |
| Contingency managementContingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on e-cigarette abstinence verified through urinary qualitative cotinine (starting at Week 2). A set amount of $20 per study visit will be delivered based on a negative qualitative urinary cotinine result. | Behavioural | Co-use group |
| CounselingPsychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study. | Behavioural | Co-use group |
Primary outcome
7-day point prevalence tobacco abstinence at the end of treatment (Week 12)
Time frame: Final 7 days of treatment (Week 12)
7-day point prevalence abstinence from e-cigarettes at the end of treatment (Week 12) will be assessed via biochemical verification (urinary cotinine; ng/ml) and will be compared to cigarette abstinence rates from the parent study (as historical controls)
2 secondary outcomes
Changes in cannabis use during e-cigarette cessation treatment
Time frame: Final 4 weeks of study treatment (Weeks 8-12)
Cannabis co-use severity on e-cigarette abstinence rates
Time frame: Final 7 days of treatment (Week 12)
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 12 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be made available for retrieval and analysis of secondary outcomes, upon request to the Principal Investigator. Study datasets (de-i
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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 A McClure, PhD principal investigator
Medical University of South Carolina
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline Pill, Contingency management and Counseling in people with Nicotine Dependence and Tobacco Use Disorder, run by Medical University of South Carolina at 3 sites 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 6 inclusion and 5 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Elizabeth Chapman, MA, LPC, LAC, AADC (864.898.2992, chapmanb@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence tobacco abstinence at the end of treatment (Week 12) (time frame: Final 7 days of treatment (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 12 Jun 2026.