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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00217971 |
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Date of registration:
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16/09/2005 |
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Primary sponsor: |
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Public title:
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Dronabinol Treatment for Marijuana Addiction
MARINOL |
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction |
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Date of first enrolment:
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March 2005 |
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Target sample size:
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156 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00217971 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Frances R Levin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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New York State Psychiatric Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Meets DSM-IV criteria for current marijuana dependence and reports marijuana as
primary drug of abuse
- Individuals must report using marijuana at least 5 days a week and have a marijuana
positive urine drug screen on the day of study entry
Exclusion Criteria:
- Meets criteria for current psychiatric disorder requiring psychiatric intervention
- History of seizures
- Known sensitivity to dronabinol
- Unstable medical conditions
- Physical dependence on any other drugs (excluding nicotine) that would require
medical detoxification
- Currently taking psychotropic medication with benefit for any other illness than
treatment of insomnia
- Pregnant or breast-feeding
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Marijuana Abuse
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Intervention(s)
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Drug: Dronabinol
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Drug: Placebo
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Primary Outcome(s)
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Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial
[Time Frame: weeks 7 and 8]
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Secondary ID(s)
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#4886-NIDA-09236-11
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DPMC
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P50DA009236
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P50DA009236-11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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