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

Information source: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Marijuana Dependence

Intervention: Escitalopram (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Tel-Aviv Sourasky Medical Center

Official(s) and/or principal investigator(s):
Miki Bloch, M.D, Principal Investigator, Affiliation: Sourasky Medical center, Tel Aviv
Aviv M Weinstein, Ph.D, Principal Investigator, Affiliation: Sourasky Medical Center Tel Aviv, Israel

Overall contact:
Aviv M Weinstein, Ph.D, Phone: 97236973685, Email: avivmw@tasmc.health.gov.il

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.

Clinical Details

Official title: Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy- a Double-Blind Placebo-Controlled Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clean urine THC samples

Secondary outcome: Questionnaire ratings of anxiety and depression and 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.

Eligibility

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Locations and Contacts

Aviv M Weinstein, Ph.D, Phone: 97236973685, Email: avivmw@tasmc.health.gov.il

Sourasky Medical Center, Tel Aviv 64239, Israel; Recruiting
Irit Ben-Avi, Ph.D, Phone: 97236973685, Email: iritbe@gmail.com
Eti Tal, B.A, Phone: 97236973685, Email: etital10@walla.com
Aviv M Weinstein, Ph.D, Principal Investigator
Miki Bloch, M.D, Principal Investigator
Additional Information

Starting date: December 2007
Last updated: March 30, 2008

Page last updated: August 23, 2015

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