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Study of Quetiapine Treatment for Cannabis Dependence (STUC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00954681
Recruitment Status : Completed
First Posted : August 7, 2009
Results First Posted : September 6, 2017
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
John Mariani MD, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE August 5, 2009
First Posted Date  ICMJE August 7, 2009
Results First Submitted Date  ICMJE August 7, 2017
Results First Posted Date  ICMJE September 6, 2017
Last Update Posted Date April 24, 2019
Study Start Date  ICMJE August 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2009)
Maximum Tolerated Dose of Quetiapine [ Time Frame: Weekly ]
Change History Complete list of historical versions of study NCT00954681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2009)
Cannabis Use [ Time Frame: Weekly ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Quetiapine Treatment for Cannabis Dependence
Official Title  ICMJE Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cannabis Dependence
Intervention  ICMJE Drug: quetiapine
Quetiapine treatment from 25 mg daily to 300 mg twice daily
Other Name: Seroquel
Study Arms  ICMJE Experimental: quetiapine treatment
Open label treatment with quetiapine
Intervention: Drug: quetiapine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2009)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00954681
Other Study ID Numbers  ICMJE 5911
K23DA021209 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Mariani MD, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: John J Mariani, MD Columbia University
PRS Account New York State Psychiatric Institute
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP