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Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy

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ClinicalTrials.gov Identifier: NCT00598052
Recruitment Status : Unknown
Verified January 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : January 18, 2008
Last Update Posted : April 1, 2008
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Tracking Information
First Submitted Date  ICMJE January 9, 2008
First Posted Date  ICMJE January 18, 2008
Last Update Posted Date April 1, 2008
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
Clean urine THC samples [ Time Frame: Every 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00598052 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
Questionnaire ratings of anxiety and depression and withdrawal symptoms [ Time Frame: Every week of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy
Official Title  ICMJE Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy- a Double-Blind Placebo-Controlled Study
Brief Summary 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.
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Marijuana Dependence
Intervention  ICMJE Drug: Escitalopram
10mg/day
Other Name: Cipralex
Study Arms  ICMJE
  • Active Comparator: A
    Escitalopram + cognitive-behavior treatment
    Intervention: Drug: Escitalopram
  • Placebo Comparator: B
    Placebo + cognitive-behavior therapy
    Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 17, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2008
Estimated Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00598052
Other Study ID Numbers  ICMJE TASMC-7.1.08-CTIL
Sponsored by IADA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Miki Bloch, Sourasky Medical center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Miki Bloch, M.D Sourasky Medical center, Tel Aviv
Principal Investigator: Aviv M Weinstein, Ph.D Sourasky Medical Center Tel Aviv, Israel
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP