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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Marijuana Dependence

Treatments: Drug: Escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT00598052

TASMC-7.1.08-CTIL

Sponsored by IADA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

Escitalopram + cognitive-behavior treatment

Treatment:

Drug: Escitalopram

B

Placebo Comparator group

Description:

Placebo + cognitive-behavior therapy

Treatment:

Drug: Escitalopram