Marijuana Dependence Clinical Trial
Official title:
Phase 1, Pilot Study to Examine the Cardiovascular Effects of Smoked Marijuana, Interactions With Oral Dronabinol, and Effects of Dronabinol on Withdrawal in Marijuana Dependent Volunteers
Verified date | February 2007 |
Source | National Institute on Drug Abuse (NIDA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant interactions before conducting outpatient studies.
Status | Terminated |
Enrollment | 6 |
Est. completion date | March 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Must be between the ages of 18 to 45 years of age - Must be in good general health - Must meet DSM-IV criteria for marijuana dependence and are non- treatment seekers at the time of study - Must be able to provide written informed consent - Must be able to provide 1 marijuana positive urine specimen (> 50 ng/mL) within the 28-day screening period - If female and of child bearing potential, must agree to use birth control. Exclusion Criteria: - Please contact site for more information. |
Country | Name | City | State |
---|---|---|---|
United States | Uniformed Services University of Health Science | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiovascular responses |
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