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Completed

NCT Number: NCT00954681

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Substance Treatment Research Service (STARS) of Columbia University

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between the ages of 18-65
  • Meets DSM-IV criteria for current cannabis dependence
  • Seeking treatment for cannabis dependence
  • Reports using cannabis an average of five days per week over the past 28 days
  • Capable of giving informed consent and complying with study procedures

Exclusion criteria

  • Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
  • 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
  • Receiving prescribed psychotropic medication
  • Known history of allergy, intolerance, or hypersensitivity to quetiapine
  • Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients who are currently engaging in sexual activity with men
  • Unstable medical conditions, such as poorly controlled diabetes or hypertension, which might make participation hazardous
  • Current DSM-IV diagnosis of substance dependence other than cannabis or nicotine dependence
  • Are legally mandated to participate in a substance use disorder treatment program
  • Increased risk for suicide
  • 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).

Treatment and study plan

Quetiapine

Drug

Quetiapine treatment from 25 mg daily to 300 mg twice daily

Other names: Seroquel

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence

Acronym: STUC

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 7, 2009
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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