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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. Identifier: NCT00954681
Recruitment Status : Completed
First Posted : August 7, 2009
Results First Posted : September 6, 2017
Last Update Posted : April 24, 2019
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
John Mariani MD, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Cannabis Dependence Drug: quetiapine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence
Study Start Date : August 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Quetiapine

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 Name: Seroquel

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00954681

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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)
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Principal Investigator: John J Mariani, MD Columbia University
Additional Information:
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Responsible Party: John Mariani MD, research psychiatrist, New York State Psychiatric Institute Identifier: NCT00954681    
Other Study ID Numbers: 5911
K23DA021209 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2009    Key Record Dates
Results First Posted: September 6, 2017
Last Update Posted: April 24, 2019
Last Verified: April 2019
Keywords provided by John Mariani MD, New York State Psychiatric Institute:
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs