Dronabinol Treatment for Marijuana Addiction - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) 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

MedlinePlus related topics: Marijuana

Drug Information available for: Tetrahydrocannabinol Cannabis GW-1000

U.S. FDA Resources

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

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:	June 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

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

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:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00217971
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Tetrahydrocannabinol
Behavior, Addictive
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 January 14, 2009