Study of Quetiapine Treatment for Cannabis Dependence

Cannabis Dependence Clinical Trial

— STUC  

Official title:

Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954681
• Other study ID #: 5911
• Secondary ID: K23DA021209
• Status: Completed
• Phase: Phase 2
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: April 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse

Intervention

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

Locations

Country	Name	City	State
United States	Substance Treatment Research Service (STARS) of Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose of Quetiapine	Mean maximum tolerated dose of quetiapine	assesssed daily during 8 weeks of study, mean maximum tolerated dose reported

External Links

•   Substance Treatment Research Service (STARS) of Columbia University