Dronabinol Treatment for Marijuana Addiction - Full Text View

Dronabinol Treatment for Marijuana Addiction (MARINOL)

This study is currently recruiting participants.

Verified by National Institute on Drug Abuse (NIDA), October 2009

First Received: September 16, 2005 Last Updated: October 15, 2009 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	New York State Psychiatric Institute
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00217971

Purpose

The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal.

Condition	Intervention	Phase
Marijuana Abuse	Drug: Dronabinol Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction

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:

Reduction of marijuana use or abstinence from marijuana (measured weekly and at Month 6) [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Withdrawal symptoms (measured bi-weekly from Week 1 through 12) [ Time Frame: biweekly ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Dronabinol	Drug: Dronabinol Dronabinol
2: Placebo Comparator placebo	Drug: Placebo placebo

Detailed Description:

Marijuana addiction is associated with significant withdrawal symptoms, including anxiety, irritability, bodily discomfort, and insomnia. The purpose of this study is to determine the effectiveness of dronabinol in reducing withdrawal symptoms.

During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, vital signs, self-report ratings, and urine samples will be collected. Participants will have a follow-up evaluation at month 6.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Meets DSM-IV criteria for current marijuana dependence and reports marijuana as primary drug of abuse
Individuals must report using marijuana at least 5 days a week and have a marijuana positive urine drug screen on the day of study entry

Exclusion Criteria:

Meets criteria for current psychiatric disorder requiring psychiatric intervention
History of seizures
Known sensitivity to dronabinol
Unstable medical conditions
Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
Currently taking psychotropic medication with benefit for any other illness than treatment of insomnia
Pregnant or breast-feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217971

Locations

United States, New York
Research Foundation for Mental Hygiene, Inc.	Recruiting
New York, New York, United States, 10032
Contact: Substance Abuse Treatment and Research Service 212-923-3031
Principal Investigator: Frances R. Levin, MD

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

New York State Psychiatric Institute

Investigators

Principal Investigator:

Frances R Levin, MD

New York State Psychiatric Institute

More Information

Additional Information:

Click here for the Substance Treatment and Abuse Research Service (STARS) website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Columbia University/NYSPI ( Frances R. Levin, M.D )
Study ID Numbers:	NIDA-09236-11, P50-09236-11, DPMC
Study First Received:	September 16, 2005
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00217971 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 November 25, 2009