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

Marijuana Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00598052
• Other study ID #: TASMC-7.1.08-CTIL
• Secondary ID: Sponsored by IAD
• Status: Recruiting
• Phase: N/A
• First received: January 9, 2008
• Last updated: March 30, 2008
• Start date: December 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Aviv M Weinstein, Ph.D
• Phone: 97236973685
• Email: avivmw[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Dependence
• Substance Withdrawal Syndrome

Intervention

Drug:
• Escitalopram
10mg/day

Locations

Country	Name	City	State
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clean urine THC samples		Every 2 weeks	No
Secondary	Questionnaire ratings of anxiety and depression and withdrawal symptoms		Every week of treatment	No