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

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

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.

Study Overview

• Status: Unknown
• Conditions: Marijuana Dependence
• Intervention / Treatment: Drug: Escitalopram

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aviv M Weinstein, Ph.D; Phone Number: 97236973685; Email: avivmw@tasmc.health.gov.il
• Study Contact Backup: Name: Eti Tal, B.A; Phone Number: 97236973685; Email: etital10@walla.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Escitalopram + cognitive-behavior treatment	Drug: Escitalopram; 10mg/day; Other Names: Cipralex
Placebo Comparator: B; Placebo + cognitive-behavior therapy	Drug: Escitalopram; 10mg/day; Other Names: Cipralex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clean urine THC samples	Every 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Questionnaire ratings of anxiety and depression and withdrawal symptoms	Every week of treatment

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Anticipated): October 1, 2008
• Study Completion (Anticipated): October 1, 2008

Study Registration Dates

• First Submitted: January 9, 2008
• First Submitted That Met QC Criteria: January 17, 2008
• First Posted (Estimate): January 18, 2008

Study Record Updates

• Last Update Posted (Estimate): April 1, 2008
• Last Update Submitted That Met QC Criteria: March 30, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Marijuana dependence withdrawal Escitalopram
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse; Substance Withdrawal Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: TASMC-7.1.08-CTIL; Sponsored by IADA