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

Primary Purpose

Marijuana Dependence

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Dependence focused on measuring Marijuana dependence withdrawal Escitalopram

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Escitalopram + cognitive-behavior treatment

Placebo + cognitive-behavior therapy

Outcomes

Primary Outcome Measures

Clean urine THC samples

Secondary Outcome Measures

Questionnaire ratings of anxiety and depression and withdrawal symptoms

Full Information

First Posted
January 9, 2008
Last Updated
March 30, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00598052
Brief Title
Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy
Official Title
Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy- a Double-Blind Placebo-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
October 2008 (Anticipated)
Study Completion Date
October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Dependence
Keywords
Marijuana dependence withdrawal Escitalopram

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Escitalopram + cognitive-behavior treatment
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo + cognitive-behavior therapy
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Cipralex
Intervention Description
10mg/day
Primary Outcome Measure Information:
Title
Clean urine THC samples
Time Frame
Every 2 weeks
Secondary Outcome Measure Information:
Title
Questionnaire ratings of anxiety and depression and withdrawal symptoms
Time Frame
Every week of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aviv M Weinstein, Ph.D
Phone
97236973685
Email
avivmw@tasmc.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Eti Tal, B.A
Phone
97236973685
Email
etital10@walla.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miki Bloch, M.D
Organizational Affiliation
Sourasky Medical center, Tel Aviv
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aviv M Weinstein, Ph.D
Organizational Affiliation
Sourasky Medical Center Tel Aviv, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irit Ben-Avi, Ph.D
Phone
97236973685
Email
iritbe@gmail.com
First Name & Middle Initial & Last Name & Degree
Eti Tal, B.A
Phone
97236973685
Email
etital10@walla.com
First Name & Middle Initial & Last Name & Degree
Aviv M Weinstein, Ph.D
First Name & Middle Initial & Last Name & Degree
Miki Bloch, M.D

12. IPD Sharing Statement

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

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