Clinical trial NCT00598052: Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy
Official title: Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy- a Double-Blind Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Marijuana Dependence
Keywords: Marijuana dependence withdrawal Escitalopram
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Clean urine THC samples
timeFrame: Every 2 weeks
Secondary outcomes:
measure: Questionnaire ratings of anxiety and depression and withdrawal symptoms
timeFrame: Every week of treatment
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Sourasky Medical center, Tel Aviv
name: Miki Bloch, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Sourasky Medical Center Tel Aviv, Israel
name: Aviv M Weinstein, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: