Ph1 Marinol INteraction Study - Part 2 - 1

This study is currently recruiting participants.

Verified by National Institute on Drug Abuse (NIDA), June 2007

First Received: June 21, 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:	NCT00490269

Purpose

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.

Condition	Intervention	Phase
Marijuana Dependence	Drug: Dronabinol	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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:	12
Study Start Date:	March 2007

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 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:

Please contact site for more information

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490269

Locations

United States, Maryland
Uniformed Services University of Health Science	Recruiting
Bethesda, Maryland, United States, 20814 4799
Contact: Louis Cantilena, M.D. 301-295-3240

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-0013-1
Study First Received:	June 21, 2007
Last Updated:	October 25, 2007
ClinicalTrials.gov Identifier:	NCT00490269 History of Changes
Health Authority:	United States: Food and Drug Administration

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 February 08, 2010