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

Sponsor:	Tel-Aviv Sourasky Medical Center
Information provided by:	Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT00598052

Purpose

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.

Condition	Intervention
Marijuana Dependence	Drug: Escitalopram

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy- a Double-Blind Placebo-Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Marijuana

Drug Information available for: Benzetimide Dexetimide GW-1000 Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate Cannabis

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

Clean urine THC samples [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Questionnaire ratings of anxiety and depression and withdrawal symptoms [ Time Frame: Every week of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2007
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Escitalopram + cognitive-behavior treatment	Drug: Escitalopram 10mg/day
B: Placebo Comparator Placebo + cognitive-behavior therapy	Drug: Escitalopram 10mg/day

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

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598052

Contacts

Contact: Aviv M Weinstein, Ph.D	97236973685	avivmw@tasmc.health.gov.il
Contact: Eti Tal, B.A	97236973685	etital10@walla.com

Locations

Israel
Sourasky Medical Center	Recruiting
Tel Aviv, Israel, 64239
Contact: Irit Ben-Avi, Ph.D 97236973685 iritbe@gmail.com
Contact: Eti Tal, B.A 97236973685 etital10@walla.com
Principal Investigator: Aviv M Weinstein, Ph.D
Principal Investigator: Miki Bloch, M.D

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator:	Miki Bloch, M.D	Sourasky Medical center, Tel Aviv
Principal Investigator:	Aviv M Weinstein, Ph.D	Sourasky Medical Center Tel Aviv, Israel

More Information

No publications provided

Responsible Party:	Sourasky Medical center ( Dr. Miki Bloch )
Study ID Numbers:	TASMC-7.1.08-CTIL, Sponsored by IADA
Study First Received:	January 9, 2008
Last Updated:	March 30, 2008
ClinicalTrials.gov Identifier:	NCT00598052 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:

Marijuana dependence withdrawal Escitalopram

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Substance Withdrawal Syndrome
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Disorders of Environmental Origin
Cholinergic Agents
Mental Disorders
Therapeutic Uses

Substance-Related Disorders
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Citalopram
Marijuana Abuse
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009