Ph1 Marinol Interaction Study - Part 2

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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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

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dronabinol

Group Type ACTIVE_COMPARATOR

Dronabinol

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

Dronabinol

Intervention Type DRUG

Other Intervention Names

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Placebo comparator arm Medication intervention

Eligibility Criteria

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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:

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Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes