This trial is active, not recruiting.

Condition marijuana dependence
Treatment dronabinol
Phase phase 1
Sponsor National Institute on Drug Abuse (NIDA)
Trial size 6 participants
Trial identifier NCT00438139, NIDA-CPU-0011-1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Cardiovascular responses
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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.

Additional Information

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
Principal investigator Louis Cantilena, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).