Ph1 Marinol Interaction Study - Part 1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Marijuana Dependence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Dronabinol

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes