Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Intervention: Dronabinol; BRENDA therapy; Placebo
Intervention description: 10mg capsules taken 4 times daily for 2 weeks and then tapered over 1 week; weekly therapy sessions for 6 weeks; 4 capsules daily for 2 weeks followed by a 1 week taper
Intervention MeSH terms: Dronabinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Marijuana; Addiction; Substance Withdrawal Syndrome; Clinical Trial; Dronabinol; Behavioral Therapy; Adults; Neuroimaging; Neuropsychological Testing; Neurocognitive Testing; Behavioral Probes

Summary:

      This treatment study is targeted specifically for those who want to stop using marijuana. We
      want to find out if patients who are dependent on marijuana and want to stop using are helped
      by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA).
      Dronabinol is a pill form of the active ingredient in marijuana (THC). Currently, dronabinol
      is approved for the treatment of nausea in people receiving cancer chemotherapy and as an
      appetite stimulant in people with AIDS.

      In some studies, dronabinol reduced the amount of psychological and physical discomfort
      experienced when people stopped using marijuana. One purpose of our study is to see if people
      who are on dronabinol have fewer problems with psychological and physical discomfort than
      those who are on a placebo.

      In addition to treatment, this research trial will also be measuring the reactions of
      subjects to drug-related cues, and also to computer-presented tasks unrelated to drug use. We
      may examine whether the response to these cues/tasks either predicts treatment outcome, or is
      affected by your treatment. This information may also help us to understand the ways in which
      chronic drug use causes changes in our subjects' mental functioning and how those changes
      respond to treatment.

      In addition to participation in the treatment research trial, some subjects may be asked to
      undergo a brain scan in an MRI. The purpose of the brain scan research project is to measure
      brain reactions with a non-invasive, non-radioactive imaging technique known as fMRI
      (functional magnetic resonance imaging) in marijuana subjects before and after treatment with
      the medication dronabinol or with an inactive substance (placebo).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females, 18-55 years old

          2. Meets DSM-IV criteria for Cannabis Dependence

          3. History of chronic cannabis use of moderate intensity defined by 10 or more years of
             use with an average frequency of 2 or more joints/day on 5 or more days/week

          4. Live within a commutable distance of the Treatment Research Center

          5. Understand and sign the informed consent

          6. Voluntarily seeking treatment for cannabis dependence

        Exclusion Criteria:

          1. Current DSM-IV diagnosis of any psychoactive substance dependence other than
             marijuana, or nicotine dependence

          2. Concomitant treatment with sedative hypnotics, opioid analgesics or other known CNS
             depressants at a dose and frequency that is unacceptable to the principal investigator

          3. Mandated to treatment based upon a legal decision or as a condition of employment

          4. Current severe psychiatric symptoms, e.g. psychosis, dementia, acute suicidal or
             homicidal ideation, mania or depression requiring antidepressant therapy, or which
             could make it unsafe for the patient to participate in the opinion of the primary
             investigators

          5. History of significant, unstable heart disease, including myocardial infarction,
             unstable angina, cardiac failure, second or third degree heart block, uncontrolled
             hypertension, syncope

          6. Known hypersensitivity to cannabinoids or sesame oil

          7. Any serious medical illness, which may require hospitalization during the study (i.e.
             sickle cell anemia, rheumatoid arthritis)

          8. Has any disease of the gastrointestinal system, liver or kidneys which could result in
             altered metabolism or excretion of the study medication (history of major
             gastrointestinal tract surgery, gastrectomy, gastrotomy, bowel resection, etc.) or
             history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis,
             or gastrointestinal bleeding)

          9. Female subjects who are pregnant or lactating, or female subjects of child bearing
             potential who are not using acceptable methods of birth control. Acceptable methods of
             birth control include:

             Barrier (diaphragm or condom) with spermicide, Intrauterine device, Levonorgestrel
             implant, Medroxyprogesterone acetate contraceptive injection, Oral contraceptives.

         10. Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits
             that are clinically unacceptable to the principal investigators. On EKG, 1st degree
             heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave
             changes are allowed. Liver function tests (LFT's) <5 times ULN without symptoms of
             liver disease are acceptable after thorough medical review.

        Additional Neuroimaging Exclusion Criteria:

        Subjects who are selected for the clinical trial based on above inclusion and exclusion
        criteria will be screened further with the following exclusion criteria for possible
        participation in the fMRI imaging session:

          1. Participation in a clinical trial and receipt of investigational drug(s) other than
             this clinical trial during previous 60 days.

          2. History of serious head trauma or injury causing loss of consciousness that lasted
             more than 3 minutes.

          3. Presence of magnetically active prosthetics, plates, pins, broken needles, permanent
             retainer, bullets, etc. in subject's body (unless a radiologist confirms that its
             presence is unproblematic). An X-ray may be obtained to determine eligibility.

          4. Claustrophobia or other medical condition disabling subject from laying in the MRI for
             approximately 60 minutes