Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 9, 2008
CompletedFirst Posted
Study publicly available on registry
January 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedApril 1, 2008
January 1, 2008
10 months
January 9, 2008
March 30, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clean urine THC samples
Every 2 weeks
Secondary Outcomes (1)
Questionnaire ratings of anxiety and depression and withdrawal symptoms
Every week of treatment
Study Arms (2)
A
ACTIVE COMPARATOREscitalopram + cognitive-behavior treatment
B
PLACEBO COMPARATORPlacebo + cognitive-behavior therapy
Interventions
Eligibility Criteria
You may qualify if:
- Men and women aged 20-45
- DSM IV criteria of marijuana dependence.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sourasky Medical Center
Tel Aviv, 64239, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miki Bloch, M.D
Sourasky Medical center, Tel Aviv
- PRINCIPAL INVESTIGATOR
Aviv M Weinstein, Ph.D
Sourasky Medical Center Tel Aviv, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
January 9, 2008
First Posted
January 18, 2008
Study Start
December 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
April 1, 2008
Record last verified: 2008-01