UH3 Varenicline for Cannabis Use Disorder
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Intervention: Varenicline; Placebo
Intervention description: Active medication; Inactive medication
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: marijuana; substance use

Summary:

      Marijuana is the most commonly used illicit drug. There is high demand for effective
      interventions for cannabis use disorder, yet few specific treatments for have been developed.
      This study will evaluate the efficacy of varenicline for reducing marijuana use in people who
      use marijuana frequently.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must meet DSM-5 criteria for cannabis use disorder and use cannabis at least 3 days
             per week in the last 30 days.

          -  Express interest in receiving treatment for cannabis use disorder and reducing use.

          -  Must be at least 18 years of age.

          -  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 35kg/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 (creatinine clearance less than 30 mL per
             minute).

          -  Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic
             disorder. Stably treated MDD, Dysthymia, GAD, Social Phobia, and Specific Phobia
             diagnoses are acceptable (i.e. same dose of medication has been prescribed for at
             least 2 months prior to screening and no changes in current medication expected during
             course of the trial).

          -  Past year or current posttraumatic stress disorder.

          -  Subjects who are actively suicidal, or who report suicidal ideation (SI) with intent
             or plan in the past year.

          -  Subjects who have a SBQ R total score ≥8, or for whom the investigator judges that a
             risk assessment by a qualified medical professional is required. Subjects answering
             'yes' on questions 4 or 5 of C-SSRS will be referred to assessment by a qualified
             mental health professional.

          -  Suicidal behavior within the past 10 years or a lifetime history of serious or
             recurrent suicidal behavior.

          -  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.

          -  Current use of buproprion or nortryptiline.

          -  Moderate or severe non-cannabis substance use disorders within the past 60 days with
             the exception of tobacco use disorder.

          -  Past year or current moderate or severe alcohol use disorder.

          -  Individuals taking an investigational agent within the last 30 days before baseline
             visit.

          -  Individuals with clinically significant medical disorders or lab abnormalities.

          -  Any individual at screening with SGOT (AST) or SGPT (ALT) greater than 3 times the
             upper limit of normal and/or total bilirubin greater than two times the upper limit of
             normal.

          -  Individuals with clinically significant cardiovascular disease in the past 6 months
             (e.g., myocardial infarction, CABG, PTCA, severe or unstable angina, serious
             arrhythmia, or any clinically significant ECG conduction abnormality.

          -  Individuals with clinically significant cerebrovascular disease in the past 6 months
             such as TIA, CVA, or stroke.

          -  Hypersensitivity to varenicline.

          -  Individuals who have participated in the clinical trial of any investigative compound
             within the last 60 days

          -  Individuals who are on probation or under a mandate to obtain treatment.

          -  Individuals with plans to initiate or change frequency of attendance at self-help
             meetings (e.g. AA, NA).