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

NCT ID: NCT00598052

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Marijuana Dependence

Keywords

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Marijuana dependence withdrawal Escitalopram

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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A

Escitalopram + cognitive-behavior treatment

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

10mg/day

B

Placebo + cognitive-behavior therapy

Group Type PLACEBO_COMPARATOR

Escitalopram

Intervention Type DRUG

10mg/day

Interventions

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Escitalopram

10mg/day

Intervention Type DRUG

Other Intervention Names

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Cipralex

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sourasky Medical center

Principal Investigators

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Miki Bloch, M.D

Role: PRINCIPAL_INVESTIGATOR

Sourasky Medical center, Tel Aviv

Aviv M Weinstein, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sourasky Medical Center Tel Aviv, Israel

Locations

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Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Aviv M Weinstein, Ph.D

Role: CONTACT

Phone: 97236973685

Email: [email protected]

Eti Tal, B.A

Role: CONTACT

Phone: 97236973685

Email: [email protected]

Facility Contacts

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Irit Ben-Avi, Ph.D

Role: primary

Eti Tal, B.A

Role: backup

Other Identifiers

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Sponsored by IADA

Identifier Type: -

Identifier Source: secondary_id

TASMC-7.1.08-CTIL

Identifier Type: -

Identifier Source: org_study_id