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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


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
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