Phase 1
N=12
Ph1 Marinol Interaction Study - Part 2 - 1
Marijuana Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00490269 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Apr 2013
Primary outcome: Primary: Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects. — 6; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo (Drug); Dronabinol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute on Drug Abuse (NIDA)
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects. |
6; 6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00490269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.