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NCT00438139 Clinical Trial

Ph1 Marinol Interaction Study - Part 1 - 1

Marijuana Dependence Clinical Trial

Official title:
Phase 1, Pilot Study to Examine the Cardiovascular Effects of Smoked Marijuana, Interactions With Oral Dronabinol, and Effects of Dronabinol on Withdrawal in Marijuana Dependent Volunteers

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00438139
Other study ID # NIDA-CPU-0011-1
Secondary ID
Status Terminated
Phase Phase 1
First received February 20, 2007
Last updated January 13, 2017
Start date March 2007
Est. completion date March 2007

Study information
Verified date February 2007
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dronabinol

Locations
Country Name City State
United States Uniformed Services University of Health Science Bethesda Maryland

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiovascular responses
See also
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