Dronabinol Treatment for Marijuana Addiction
Condition: Marijuana Abuse
MeSH terms: Marijuana Abuse
Intervention: Dronabinol; Placebo
Intervention description: Dronabinol; placebo
Intervention MeSH terms: Dronabinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cannabis dependence; dronabinol; treatment

Summary:

      The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana
      addiction and withdrawal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  men and women between the ages of 18-60

          -  Meets DSM-IV criteria for current marijuana dependence and reports marijuana as
             primary drug of abuse

          -  Individuals must report using marijuana at least 5 days a week and have a marijuana
             positive urine drug screen on the day of study entry

          -  Individuals must be capable of giving informed consent and capable of complying with
             study procedures.

          -  Women of child-bearing age will be included in the study provided that they are not
             pregnant, based on the results of a blood pregnancy test drawn at the time of
             screening. They must also agree to use a method of contraception with proven efficacy
             and agree not to become pregnant during the study. To confirm this, blood pregnancy
             tests will be repeated monthly. Women will be provided a full explanation of the
             potential dangers of pregnancy while on the study medication. If a woman becomes
             pregnant, the study medication will be discontinued.

        Exclusion Criteria:

          -  Meets criteria for current psychiatric disorder requiring psychiatric intervention.
             Disorders that are stable on psychotherapy or pharmacotherapy will not be
             exclusionary. Individuals will be permitted to take prescribed zolpidem and zaleplon
             if there is no evidence of dependence on these substances.

          -  History of seizures

          -  Known sensitivity to dronabinol

          -  Unstable medical conditions

          -  Physical dependence on any other drugs (excluding nicotine) that would require medical
             detoxification

          -  Currently taking psychotropic medication with benefit for any other illness than
             treatment of insomnia

          -  Pregnant or breast-feeding

          -  Individuals who have exhibited suicidal or homicidal behavior within the past two
             years or who have current active suicidal ideation.

          -  Individuals with coronary vascular disease as indicated by history of abnormal ECG or
             history of cardiac symptoms.

          -  Unstable physical disorder which might make participation hazardous such as
             uncontrolled hypertension (SBP > 150, DBP> 90, or HR > 100 when sitting quietly),
             acute hepatitis (patients with chronic mildly elevated transaminases < 2-3X upper
             limit of normal are acceptable), or medically unstable diabetes.

          -  Subjects in professions in which even mild intoxication would be hazardous (e.g.,
             police officer, bus driver, firefighter).

          -  Individuals who are court-mandated to treatment.