Study of Quetiapine Treatment for Cannabis Dependence (STUC)

April 22, 2019 updated by: John Mariani MD, New York State Psychiatric Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: quetiapine treatment
Open label treatment with quetiapine
Drug: quetiapine
Quetiapine treatment from 25 mg daily to 300 mg twice daily
Other Names:
  • Seroquel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose of Quetiapine
Time Frame: assesssed daily during 8 weeks of study, mean maximum tolerated dose reported
Mean maximum tolerated dose of quetiapine
assesssed daily during 8 weeks of study, mean maximum tolerated dose reported

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: John J Mariani, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (Estimate)

August 7, 2009

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5911
  • K23DA021209 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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