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

Tracking Information

First Received Date ^ICMJE

January 9, 2008

Last Updated Date

March 30, 2008

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

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

Original Secondary Outcome Measures ^ICMJE

Same as current

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Marijuana Dependence

Intervention ^ICMJE

Drug: Escitalopram

Study Arms / Comparison Groups

Active Comparator: Escitalopram + cognitive-behavior treatment
Placebo Comparator: Placebo + cognitive-behavior therapy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

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.

Gender

Both

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00598052

Responsible Party

Dr. Miki Bloch, Sourasky Medical center

Study ID Numbers ^ICMJE

TASMC-7.1.08-CTIL, Sponsored by IADA

Study Sponsor ^ICMJE

Tel-Aviv Sourasky Medical Center

Collaborators ^ICMJE

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

Information Provided By

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