WithdrawnPhase 2

Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans

Stopped: Despite the numerous approaches below, we have not been successful in identifying a recruitment pathway that would ensure feasibility of study continuation. We have had multiple meetings with CSR\&D leadership to discuss our study progress

United States0Started 2023-04-17

Plain-language summary

After initial eligibility screening, Veterans who use both cannabis and tobacco will be randomly assigned to receive either varenicline (Chantix) or placebo for 12 weeks. Participants will attend weekly visits, in person or remotely, to provide breath and urine samples for testing, fill out questionnaires, and meet with study staff about medication compliance.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meet DSM-5 criteria for cannabis use disorder and use cannabis at least 3 days per week in the last 30 days. * Meet DSM-5 criteria for tobacco use disorder and smoke at least five cigarettes or report vaping 5 mg of nicotine daily. * Males and female Veterans aged 18 and over. * Be interested in quitting or reducing cannabis and tobacco use. * If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial. * Must consent to random assignment, and be willing to commit to medication ingestion. * Must be able to read and provide informed consent. * Must have body weight \>110lbs (50kg) and have BMI between 18 and 35 kg/m2 * Must function at an intellectual level and have knowledge of the English language to sufficiently allow for accurate completion of assessments. Exclusion Criteria: * Women who are pregnant, nursing, or plan to become pregnant during the course of the study. * Individuals with severe renal impairment. * Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic disorder. Stably treated MDD, Dysthymia, GAD, Social Phobia, PTSD, and Specific Phobia diagnoses are acceptable (i.e. same dose of medication/psychotherapy has been prescribed for at least 2 months prior to screening and no changes in current medication/psychotherapy expected during course of the trial). * Suicidal ideation or behavior within the past 6 months. Subjects who are believed to be…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of cannabis using day as reported on Timeline Followback

Timeframe: Weeks 6-12

Average number cigarettes smoked per day as reported on Timeline Followback

Timeframe: Weeks 6-12

Trial details

NCT IDNCT05294263

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-07-17

View on ClinicalTrials.gov More Tobacco Use Disorder trials