Dronabinol Treatment for Marijuana Addiction
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Marijuana Abuse
Intervention: Dronabinol (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Frances R Levin, MD, Principal Investigator, Affiliation: New York State Psychiatric Institute
Summary
The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana
addiction and withdrawal.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Reduction of marijuana use or abstinence from marijuana (measured weekly and at Month 6)
Secondary outcome: Withdrawal symptoms (measured bi-weekly from Week 1 through 12)
Detailed description:
Marijuana addiction is associated with significant withdrawal symptoms, including anxiety,
irritability, bodily discomfort, and insomnia. The purpose of this study is to determine the
effectiveness of dronabinol in reducing withdrawal symptoms.
During this twelve-week, double-blind, placebo-controlled study, study visits will occur
twice each week. During study visits, participants will receive either placebo or
medication. Throughout the study, all participants will receive individualized psychotherapy
sessions. At each study visit, vital signs, self-report ratings, and urine samples will be
collected. Participants will have a follow-up evaluation at month 6.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Research Foundation for Mental Hygiene, Inc., New York, New York 10032, United States; Recruiting
Substance Abuse Treatment and Research Service, Phone: 212-923-3031
Frances R. Levin, MD, Principal Investigator
Additional Information
Click here for the Substance Treatment and Abuse Research Service (STARS) website
Starting date: March 2005
Ending date: December 2009
Last updated: October 15, 2009
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