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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Marijuana Dependence

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Escitalopram + cognitive-behavior treatment | Drug: Escitalopram<br>* 10mg/day<br>* Other names: Cipralex;|
| Placebo Comparator: B<br>Placebo + cognitive-behavior therapy | Drug: Escitalopram<br>* 10mg/day<br>* Other names: Cipralex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clean urine THC samples |  | Every 2 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Marijuana dependence withdrawal Escitalopram