Ph1 Marinol Interaction Study - Part 2 - 1



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 45
Updated:1/13/2017
Start Date:October 2006
End Date:December 2007

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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

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.


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
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