Ph1 Marinol Interaction Study - Part 1 - 1

Condition(s) targeted: Marijuana Dependence

Intervention: Dronabinol (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Louis Cantilena, M.D., Principal Investigator, Affiliation: Uniformed Services University of Health Science

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: Cardiovascular responses

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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.

Uniformed Services University of Health Science, Bethesda, Maryland 20814 4799, United States

Last updated: October 25, 2007