Ph1 Marinol INteraction Study - Part 2 - 1

Condition(s) targeted: Marijuana Dependence

Intervention: Dronabinol (Drug)

Phase: Phase 1

Status: 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

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.

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, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Cardiovascular responses

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

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

Uniformed Services University of Health Science, Bethesda, Maryland 20814 4799, United States; Recruiting
Louis Cantilena, M.D., Phone: 301-295-3240

Starting date: March 2007
Last updated: October 25, 2007