Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy
Information source: Tel-Aviv Sourasky Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
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: Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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
Ending date: October 2008
Last updated: March 30, 2008
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