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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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 to provide breath and urine samples for testing, fill out questionnaires, and meet with study staff about medication compliance.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Varenicline

Criteria

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 per day.

• 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 at suicidal (answers 'yes' on questions 4 or 5 of C-SSRS) or homicidal risk will be referred to assessment by a mental health professional.

• Concomitant use of psychotropic medications, with the exception of stable doses (defined as no dosing adjustments in the past two months) of non-MAO-I antidepressants, non-benzodiazepine anxiolytics, and ADHD medications.

• Current use of medications prescribed for mania or psychosis (these medications may be allowed if used for other indications)

• Current use of bupropion, amitriptyline or nortryptiline or other medication known to have drug interactions with varenicline

• Moderate or severe non-cannabis substance use disorders within the past 60 days with the exception of tobacco use disorder.

• Individuals taking an investigational agent within the last 30 days before baseline visit.

• Individuals with clinically significant medical disorders or lab abnormalities.

• Individuals with clinically significant cardiovascular disease in the past 6 months (e.g., myocardial infarction, CABG, PTCA, or severe or unstable angina).

• Individuals with clinically significant cerebrovascular disease in the past 6 months such as TIA, CVA, or stroke

• Hypersensitivity to varenicline.