Official Title: “Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence”

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:

1. be safe when administered to patients actively using cannabis

2. reduce cannabis intake and promote abstinence

3. treat the symptoms of cannabis withdrawal

4. reduce craving and relapse risk

5. 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.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2010

Intervention(s) in this Clinical Trial

• Drug: quetiapine
  • Quetiapine treatment from 25 mg daily to 300 mg twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: quetiapine treatment

Primary Measures

• Maximum tolerated dose of quetiapine
  • Time Frame: Weekly
    Safety Issue?: Yes

Secondary Measures

• Cannabis Use
  • Time Frame: Weekly
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• 1. Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
• 2. 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
• 3. Receiving prescribed psychotropic medication
• 4. Known history of allergy, intolerance, or hypersensitivity to quetiapine
• 5. Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients who are currently engaging in sexual activity with men
• 6. Unstable medical conditions, such as poorly controlled diabetes or hypertension, which might make participation hazardous
• 7. Current DSM-IV diagnosis of substance dependence other than cannabis or nicotine dependence
• 8. Are legally mandated to participate in a substance use disorder treatment program
• 9. Increased risk for suicide
• 10. 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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: New York State Psychiatric Institute

Overall Clinical Trial Officials and Contacts

John J Mariani, MD Principal Investigator Columbia University  

Overall Contact: John J Mariani, MD 212-543-5987 jm2330@columbia.edu

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00954681

Study ID Number: 5911

ClinicalTrials.gov Identifier: NCT00954681

Health Authority: United States: Institutional Review Board

Substance Treatment Research Service (STARS) of Columbia University