Ph1 Marinol Interaction Study - Part 1 - 1

This study is ongoing, but not recruiting participants.

First Received: February 20, 2007 Last Updated: October 25, 2007 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00438139

Purpose

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.

Condition	Intervention	Phase
Marijuana Dependence	Drug: Dronabinol	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Marijuana

Drug Information available for: Tetrahydrocannabinol

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Cardiovascular responses

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438139

Locations

United States, Maryland
Uniformed Services University of Health Science
Bethesda, Maryland, United States, 20814 4799

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Louis Cantilena, M.D.

Uniformed Services University of Health Science

More Information

No publications provided

Study ID Numbers:	NIDA-CPU-0011-1
Study First Received:	February 20, 2007
Last Updated:	October 25, 2007
ClinicalTrials.gov Identifier:	NCT00438139 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Hallucinogens
Marijuana Abuse
Pharmacologic Actions
Tetrahydrocannabinol
Sensory System Agents

Mental Disorders
Analgesics, Non-Narcotic
Therapeutic Uses
Substance-Related Disorders
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009