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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00598052
First received: January 9, 2008
Last updated: March 30, 2008
Last verified: January 2008
History of Changes
  Purpose

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.


Condition Intervention
Marijuana Dependence
 Drug: Escitalopram

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy- a Double-Blind Placebo-Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Clean urine THC samples [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Questionnaire ratings of anxiety and depression and withdrawal symptoms [ Time Frame: Every week of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2007
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Escitalopram + cognitive-behavior treatment
 Drug: Escitalopram
10mg/day
Other Name: Cipralex
Placebo Comparator: B
Placebo + cognitive-behavior therapy
 Drug: Escitalopram
10mg/day
Other Name: Cipralex

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.
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598052

Contacts
Contact: Aviv M Weinstein, Ph.D 97236973685 avivmw@tasmc.health.gov.il
Contact: Eti Tal, B.A 97236973685 etital10@walla.com

Locations
Israel
Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Irit Ben-Avi, Ph.D     97236973685     iritbe@gmail.com    
Contact: Eti Tal, B.A     97236973685     etital10@walla.com    
Principal Investigator: Aviv M Weinstein, Ph.D            
Principal Investigator: Miki Bloch, M.D            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Miki Bloch, M.D Sourasky Medical center, Tel Aviv
Principal Investigator: Aviv M Weinstein, Ph.D Sourasky Medical Center Tel Aviv, Israel
  More Information

No publications provided

Responsible Party: Dr. Miki Bloch, Sourasky Medical center
ClinicalTrials.gov Identifier: NCT00598052     History of Changes
Other Study ID Numbers: TASMC-7.1.08-CTIL, Sponsored by IADA
Study First Received: January 9, 2008
Last Updated: March 30, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Marijuana dependence withdrawal Escitalopram

Additional relevant MeSH terms:
Marijuana Abuse
Substance Withdrawal Syndrome
Substance-Related Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on May 19, 2013