Ph1 Marinol Interaction Study - Part 2 - 1
- Registration Number
- NCT00490269
- Lead Sponsor
- National Institute on Drug Abuse (NIDA)
- Brief Summary
This study will 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 drug interactions before conducting outpatient studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Must be between 18 and 45 years of age
- Must be in good general health and who meet DSM-IV diagnostic criteria for marijuana dependence
- Must be seeking treatment at time of study entry
- Must be able to understand and provide written informed consent
- Must provide 1 marijuana positive urine specimen (> 50 ng/mL) within the 28-day screening period
- If female and of child bearing potential, agrees to use birth control.
Exclusion
Criteria:
- Please contact site for more information
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Dronabinol Dronabinol -
- Primary Outcome Measures
Name Time Method Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects. Day 9 and 10 Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Uniformed Services University of Health Science
🇺🇸Bethesda, Maryland, United States