Ph1 Marinol Interaction Study - Part 1 - 1

National Institutes of Health (NIH)

Status and phase: Terminated; Phase 1

Conditions: Marijuana Dependence

Treatments: Drug: Dronabinol

Study type: Interventional

Funder types: NIH

Identifiers

NCT00438139

NIDA-CPU-0011-1

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)