Ph1 Marinol Interaction Study - Part 1 - 1

Phase 1TerminatedNCT00438139

National Institute on Drug Abuse (NIDA)6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Marijuana Dependence

Interventions

DronabinolDRUG

Eligibility

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

Medical Language ↔ Plain English

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.

Locations (1)

Uniformed Services University of Health Science

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

Cardiovascular responses

Data from ClinicalTrials.gov

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