Ph1 Marinol Interaction Study - Part 2 - 1

National Institute on Drug Abuse (NIDA)12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Marijuana Dependence

Interventions

PlaceboDRUG

DronabinolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Uniformed Services University of Health Science

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.

Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.

Time frame: Day 9 and 10

Data from ClinicalTrials.gov

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