Dronabinol Treatment for Marijuana Addiction - Full Text View

Sponsor:	New York State Psychiatric Institute
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):	New York State Psychiatric Institute
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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 New York State Psychiatric Institute:

Primary Outcome Measures:

Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial [ Time Frame: weeks 7 and 8 ] [ Designated as safety issue: No ]
Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.

Enrollment:	156
Study Start Date:	March 2005
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Dronabinol Dronabinol: 20mg bid for a daily maximum dose of 40mg.	Drug: Dronabinol Dronabinol Other Name: Marinol
Placebo Comparator: Placebo 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.
New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Frances R Levin, MD

New York State Psychiatric Institute

More Information

No publications provided

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00217971 History of Changes
Other Study ID Numbers:	NIDA-09236-11,#4886, P50DA009236, P50DA009236-11, DPMC
Study First Received:	September 16, 2005
Results First Received:	September 13, 2011
Last Updated:	January 3, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012