Ph1 Marinol Interaction Study - Part 1 - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

February 20, 2007

Last Updated Date

October 25, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Cardiovascular responses

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00438139 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Ph1 Marinol Interaction Study - Part 1 - 1

Official Title ^ICMJE

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

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Marijuana Dependence

Intervention ^ICMJE

Drug: Dronabinol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00438139

Responsible Party

Study ID Numbers ^ICMJE

NIDA-CPU-0011-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Louis Cantilena, M.D.

Uniformed Services University of Health Science

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP