Ph1 Marinol Interaction Study - Part 1 - 1 - Full Text View

Ph1 Marinol Interaction Study - Part 1 - 1

This study is ongoing, but not recruiting participants.

Sponsored by:	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

Drug Information available for:

Tetrahydrocannabinol Cannabis GW-1000

U.S. FDA Resources

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

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

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

Study placed in the following topic categories:

Tetrahydrocannabinol

Mental Disorders

Substance-Related Disorders

Disorders of Environmental Origin

Marijuana Abuse

Additional relevant MeSH terms:

Sensory System Agents

Analgesics, Non-Narcotic

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Hallucinogens

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008