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Study of Quetiapine Treatment for Cannabis Dependence (STUC)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00954681
First received: August 5, 2009
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  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:

  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.

Condition Intervention Phase
Cannabis Dependence
 Drug: quetiapine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence

Resource links provided by NLM:

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 ]

Enrollment: 15
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: quetiapine treatment
Open label treatment with quetiapine
 Drug: quetiapine
Quetiapine treatment from 25 mg daily to 300 mg twice daily
Other Name: Seroquel

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954681

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

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00954681     History of Changes
Other Study ID Numbers: 5911, K23DA021209
Study First Received: August 5, 2009
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Cannabis
quetiapine

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013