Ph1 Marinol Interaction Study - Part 2 - 1

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Marijuana Dependence

Treatments: Drug: Dronabinol; Drug: Placebo

Study type: Interventional

Funder types: NIH

Identifiers

NCT00490269

NIDA-CPU-0013-1

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

12 participants in 2 patient groups, including a placebo group

Dronabinol

Active Comparator group

Treatment:

Drug: Dronabinol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo