Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose of Quetiapine
研究概览
简要总结
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:
- be safe when administered to patients actively using cannabis
- reduce cannabis intake and promote abstinence
- treat the symptoms of cannabis withdrawal
- reduce craving and relapse risk
- have a low abuse liability.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
quetiapine treatment
Open label treatment with quetiapine
干预措施: quetiapine (Drug)
结局指标
主要结局
Maximum Tolerated Dose of Quetiapine
时间窗: assesssed daily during 8 weeks of study, mean maximum tolerated dose reported
Mean maximum tolerated dose of quetiapine
次要结局
未报告次要终点
研究者
John Mariani MD
research psychiatrist
New York State Psychiatric Institute