A Randomized, Double-Blind, Placebo-Controlled Study of
Dronabinol in the Treatment of Marijuana Dependence
Please refer to this study by identifier 4886
Principal Investigator(s) Frances Levin
Purpose
The specific aims of this research proposal are as follows:
1) To determine whether dronabinol is superior to placebo in promoting abstinence in marijuana-dependent individuals.
2) To determine whether dronabinol is superior to placebo in reducing marijuana withdrawal symptoms in marijuana-dependent individuals.
3) To determine whether the effects of dronabinol on marijuana withdrawal mediates abstinence in marijuana use/dependence (mediation analysis).
Type of Study: Clinical Trial Setting of Study: Clinical Trials.gov number: NCT00217971 Providing Clinical Treatment?: Yes No Cost Treatment?: Yes
Study Activities
Eligibility
Ages Eligible for Study: 18 Years - 60 Years Genders Eligible for Study: Both
This study is not recruiting Healthy Volunteers.
Criteria
Inclusion Criteria: CRITERION
Inclusion:
1. Men and women between the ages of 18-60
who meet DSM-IV criteria for current
marijuana dependence.
2. 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.
3. Individuals must describe marijuana as their
primary drug of abuse.
4. Individuals must be capable of giving informed
consent and capable of complying with study
procedures.
5. Women of child bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.
Location: Clinic: Substance Treatment and Research Services Division: Substance Abuse
Study chairs or principal investigators: Frances R Levin MD, Principal Investigator