Study of Quetiapine Treatment for Cannabis Dependence

NCT ID: NCT00954681

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Cannabis Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

quetiapine treatment

Open label treatment with quetiapine

Group Type: EXPERIMENTAL

quetiapine

Intervention Type: DRUG

Quetiapine treatment from 25 mg daily to 300 mg twice daily

Interventions

quetiapine

Quetiapine treatment from 25 mg daily to 300 mg twice daily

Intervention Type: DRUG

Other Intervention Names

Seroquel

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

John Mariani MD

research psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John J Mariani, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Substance Treatment Research Service (STARS) of Columbia University

New York, New York, United States

Countries

United States

Related Links

http://www.stars.columbia.edu

Substance Treatment Research Service (STARS) of Columbia University

Other Identifiers

K23DA021209

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5911

Identifier Type: -

Identifier Source: org_study_id