Official Title: “Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy- a Double-Blind Placebo-Controlled Study”

Recent studies have established the reliability, validity and time course of the cannabis withdrawal syndrome. This study will investigate the effects of combined treatment of Escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana withdrawal syndrome in regular chronic users of marijuana. We predict that combined pharmacological treatment and cognitive-behavior therapy will help patients to abstain from using using marijuana and it will alleviate their marijuana withdrawal symptoms.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2008

Recent studies have established the reliability, validity and time course of the cannabis withdrawal syndrome characterized by symptoms of anxiety, irritability, negative mood, physical symptoms and decreased appetite. This study will investigate the effects of combined treatment of Escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana withdrawal syndrome in regular chronic users of marijuana. 40 patients will be blindly randomized to either active or placebo escitalopram 10mg/day, for 12 weeks followed bt 12 weeks of follow-up.

Inclusion criteria include: - Men and women age 20-45 - DSM-IV diagnosis of THC dependence.

Exclusion criteria include: - Dependence on other drugs or alcohol - Bipolar Disorder or Schizophrenia, Major depression, suicidal ideation psychotic symptoms or violent thoughts - Current treatment with anti-depressant medication - Neurological disease - Physical illness (hypothyroidism, severe anemia, renal failure) - Past severe effects of SSRIs.

Outcome measures include: - urine THC analysis every two weeks - questionnaires assessing addiction severity index - depression and anxiety.

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • 10mg/day

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Escitalopram + cognitive-behavior treatment
• Placebo Comparator: B
  • Placebo + cognitive-behavior therapy

Primary Measures

• Clean urine THC samples
  • Time Frame: Every 2 weeks
    Safety Issue?: No

Secondary Measures

• Questionnaire ratings of anxiety and depression and withdrawal symptoms
  • Time Frame: Every week of treatment
    Safety Issue?: No

Inclusion Criteria:

• Men and women aged 20-45
• DSM IV criteria of marijuana dependence.

Exclusion Criteria:

• Other drug or alcohol dependence
• Bipolar disorder, schizophrenia, major depression, suicidal ideation, psychotic symptoms or violent thoughts
• Physical illness including hypothyroidism, neurological disease, severe anemia, and renal failure
• Past severe side effects of SSRIs.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Tel-Aviv Sourasky Medical Center

Overall Clinical Trial Officials and Contacts

Miki Bloch, M.D Principal Investigator Sourasky Medical center, Tel Aviv  

Overall Contact: Aviv M Weinstein, Ph.D 97236973685 avivmw@tasmc.health.gov.il

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00598052

Study ID Number: TASMC-7.1.08-CTIL

ClinicalTrials.gov Identifier: NCT00598052

Health Authority: Israel: Ministry of Health