Pilot Study of Quetiapine Treatment for Cannabis Dependence - Full Text View

Sponsor:	New York State Psychiatric Institute
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00954681

Purpose

Marijuana is the most commonly used illicit drug in the United States. However, the treatment options for cannabis dependence are limited; notably, no effective pharmacotherapy has been developed. Conceptually, the ideal medication treatment for cannabis dependence would:

be safe when administered to patients actively using cannabis
reduce cannabis intake and promote abstinence
treat the symptoms of cannabis withdrawal
reduce craving and relapse risk
have a low abuse liability.

Conceptually, the pharmacodynamic and clinical actions of quetiapine suggest that it may be useful for cannabis dependence. By antagonizing dopamine, quetiapine may interfere with the reinforcing effects of cannabis, while serotonin type 2A, histamine type 1, and adrenergic receptor antagonism may reduce cannabis withdrawal symptoms, primarily by sedating and anxiolytic effects. The proposed research project is an open-label pilot study to evaluate the tolerability and ideal target dosing range for quetiapine treatment of cannabis dependence over an eight-week period. The purpose of this pilot study is to obtain preliminary data regarding the potential efficacy, tolerability and safety of quetiapine treatment of cannabis dependence before conducting a larger double-blind trial.

Condition	Intervention	Phase
Cannabis Dependence	Drug: quetiapine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence

Resource links provided by NLM:

Drug Information available for: GW-1000 Quetiapine Quetiapine fumarate Cannabis

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:

Maximum tolerated dose of quetiapine [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cannabis Use [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
quetiapine treatment: Experimental	Drug: quetiapine Quetiapine treatment from 25 mg daily to 300 mg twice daily

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between the ages of 18-65
Meets DSM-IV criteria for current cannabis dependence
Seeking treatment for cannabis dependence
Reports using cannabis an average of five days per week over the past 28 days
Capable of giving informed consent and complying with study procedures

Exclusion Criteria:

Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
Current DSM-IV criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non-pharmacological intervention over the course of the study
Receiving prescribed psychotropic medication
Known history of allergy, intolerance, or hypersensitivity to quetiapine
Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients who are currently engaging in sexual activity with men
Unstable medical conditions, such as poorly controlled diabetes or hypertension, which might make participation hazardous
Current DSM-IV diagnosis of substance dependence other than cannabis or nicotine dependence
Are legally mandated to participate in a substance use disorder treatment program
Increased risk for suicide
Diabetes (whether controlled or not), hyperglycemia (fasting glucose > 100 mg/dl), obesity (BMI > 30) and elevated lipids (cholesterol > 200 mg/dl; triglycerides > 150 mg/dl).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954681

Contacts

Contact: John J Mariani, MD

212-543-5987

jm2330@columbia.edu

Locations

United States, New York
Substance Treatment Research Service (STARS) of Columbia University	Recruiting
New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

John J Mariani, MD

Columbia University

More Information

Additional Information:

Substance Treatment Research Service (STARS) of Columbia University This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Columbia University ( John J. Mariani, MD )
Study ID Numbers:	5911, K23DA021209
Study First Received:	August 5, 2009
Last Updated:	August 17, 2009
ClinicalTrials.gov Identifier:	NCT00954681 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:

Cannabis
quetiapine

Additional relevant MeSH terms:

Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Central Nervous System Depressants
Antipsychotic Agents
Marijuana Abuse

Pharmacologic Actions
Quetiapine
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010