Status:
WITHDRAWN
Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans
Lead Sponsor:
VA Office of Research and Development
Conditions:
Tobacco Use Disorder
Cannabis Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 week...
Detailed Description
Screening and Eligibility Assessment. Individuals will be screened by the research study intake coordinator. An initial pre-screen focused on inclusion/exclusion psychiatric diagnoses, medical status,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05294263
Start Date
April 17 2023
End Date
July 17 2024
Last Update
August 27 2024
Active Locations (1)
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1
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5703