Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Intervention: Clonazepam; Placebo
Intervention description: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
Intervention MeSH terms: Clonazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Marijuana; Treatment

Summary:

      The proposed protocol is a double-blind, placebo-controlled inpatient and outpatient
      study,looking at the clinical treatment of cannabis use disorder.

      The treatment study is a total of 12 weeks. There will be two options offered to participants
      for week 1 of the treatment study. 1) Patient will go inpatient for 5 nights and after
      discharge from the inpatient phase will complete the 11-weeks of outpatient treatment or 2)
      patients who cannot complete the inpatient phase due to work or other obligations will
      complete the treatment 12-week study outpatient. 80 patients seeking treatment for cannabis
      use disorder will be enrolled into either the inpatient/outpatient or only outpatient study.
      This combined design will provide a comprehensive understanding of clonazepam's effects on
      individuals with cannabis use disorder across a range of outcome measures while also testing
      the medication's ability to prevent relapse in cannabis-abstinent patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM 5 criteria for CUD of at least moderate severity (≥ 4 symptoms) and is
             seeking treatment for cannabis use.

          -  Reports using cannabis a minimum of 5 days per week over the past 28 days and have
             positive urine test for THC on the day of study entry

          -  18-65 years of age

        Exclusion Criteria:

          -  Individuals with a lifetime DSM-5 diagnosis of schizophrenia, schizoaffective
             disorder, or bipolar disorder

          -  Individuals meeting current DSM-5 criteria for any other psychiatric disorder that
             may, according to the investigator's judgment, require either pharmacological or
             non-pharmacological intervention over the course of the study. Individuals who are
             currently stable on a psychotropic medication for at least 3 months may be included if
             in the investigator's opinion the psychotropic medication is compatible with the study
             medication (clonazepam). CNS depressants (e.g., benzodiazepines, opioids, adrenergic
             agonists) and cyp3A4 inhibitors (ketoconazole, some antipsychotics & anticonvulsants)
             will be exclusionary.

          -  Known history of allergy, intolerance or hypersensitivity to benzodiazepines

          -  Episodic or chronic use of benzodiazepines

          -  Pregnancy, lactation, or failure to use adequate contraceptive methods (condoms,
             diaphragm, birth control pill, IUD) in female patients who are currently engaging in
             sexual activity with men.

          -  Unstable medical conditions, such as poorly controlled hypertension, which might make
             participation hazardous

          -  Participants with a current DSM-5 diagnosis of an alcohol of substance use disorder
             (abuse or dependence) other than cannabis or nicotine use disorder

          -  Are legally mandated to participate in a substance use disorder treatment program

          -  Increased risk for suicide

          -  Current parole or probation

          -  Recent history of significant violent behavior

          -  History of current of past diagnosis of glaucoma

          -  History of benzodiazepine or other sedative hypnotic use disorder