Ph1 Marinol Interaction Study - Part 1 - 1

Phase 1

Terminated

• Conditions: Marijuana Dependence

• Registration Number: NCT00438139
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-02
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-21
• Study Start: 2007-03
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cardiovascular responses

Trial Locations

Locations (1)

Uniformed Services University of Health Science; 🇺🇸 Bethesda, Maryland, United States