Facilitating the Behavioral Treatment of Cannabis Use Disorder
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Intervention: CI-581a
Intervention description: CI-581a will be administered in wk2 and potentially in wk 3 or 4.
Intervention MeSH terms: Ketamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Participant)
Masking description: Open label single-blind trial, with participants given the impression they may get any of several medications.
Enrollment: 8.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: cannabis; mindfulness based relapse prevention; motivational enhancement therapy

Summary:

      Cannabis use disorders remain a significant public health problem. The pharmacological
      facilitation of behavioral treatment represents a promising strategy for addressing
      disordered cannabis use. Cannabis use disorders are recognized to be associated with various
      vulnerabilities that complicate the course of treatment and that may be amenable to glutamate
      modulators. The purpose of this single blind open-label trial is to test the feasibility of
      administering glutamate modulators in conjunction with motivational enhancement therapy (MET)
      and mindfulness based relapse prevention (MBRP) for cannabis use disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for cannabis dependence, with at least 5 days of use per week
             over the past 30 days and displaying at least one positive utox during screening

          -  Physically healthy

          -  No adverse reactions to study medications

          -  21-60 years of age

          -  Capacity to consent and comply with study procedures

          -  Seeking treatment

        Exclusion Criteria:

          -  Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia,
             any psychotic illness, including substance-induced psychosis, and current
             substance-induced mood disorder.

          -  Physiological dependence on another substance requiring medical management, such as
             alcohol, opioids, or benzodiazepines, excluding caffeine, and nicotine.

          -  Pregnant, interested in becoming pregnant, or lactating

          -  Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders

          -  Current suicide risk or a history of suicide attempt within the past 2 years

          -  On psychotropic or other medication whose effect could be disrupted by participation
             in the study

          -  Recent history of significant violence (past 2 years).

          -  Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.

          -  Unstable physical disorders which might make participation hazardous such as end-stage
             AIDS, hypertension (>140/90), anemia, pulmonary disease, active hepatitis or other
             liver disease (transaminase levels < 2-3 X the upper limit of normal will be
             considered acceptable), or untreated diabetes

          -  Previous history of misuse of study medications

          -  BMI > 35, or a history of undocumented obstructive sleep apnea

          -  First degree relative with a psychotic disorder (bipolar disorder with psychotic
             features, schizophrenia, schizoaffective disorder, or psychosis NOS)