A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial
研究概览
简要总结
The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal.
详细描述
Marijuana addiction is associated with significant withdrawal symptoms, including anxiety, irritability, bodily discomfort, and insomnia. The purpose of this study is to determine the effectiveness of dronabinol in reducing withdrawal symptoms.
During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, vital signs, self-report ratings, and urine samples will be collected. Participants will have a follow-up evaluation at month 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women between the ages of 18-60
- •Meets DSM-IV criteria for current marijuana dependence and reports marijuana as primary drug of abuse
- •Individuals must report using marijuana at least 5 days a week and have a marijuana positive urine drug screen on the day of study entry
- •Individuals must be capable of giving informed consent and capable of complying with study procedures.
- •Women of child-bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.
排除标准
- •Meets criteria for current psychiatric disorder requiring psychiatric intervention. Disorders that are stable on psychotherapy or pharmacotherapy will not be exclusionary. Individuals will be permitted to take prescribed zolpidem and zaleplon if there is no evidence of dependence on these substances.
- •History of seizures
- •Known sensitivity to dronabinol
- •Unstable medical conditions
- •Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
- •Currently taking psychotropic medication with benefit for any other illness than treatment of insomnia
- •Pregnant or breast-feeding
- •Individuals who have exhibited suicidal or homicidal behavior within the past two years or who have current active suicidal ideation.
- •Individuals with coronary vascular disease as indicated by history of abnormal ECG or history of cardiac symptoms.
- •Unstable physical disorder which might make participation hazardous such as uncontrolled hypertension (SBP > 150, DBP> 90, or HR > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases < 2-3X upper limit of normal are acceptable), or medically unstable diabetes.
- •Subjects in professions in which even mild intoxication would be hazardous (e.g., police officer, bus driver, firefighter).
- •Individuals who are court-mandated to treatment.
研究组 & 干预措施
Dronabinol
Dronabinol: 20mg bid for a daily maximum dose of 40mg.
干预措施: Dronabinol (Drug)
Placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial
时间窗: weeks 7 and 8
Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.
次要结局
未报告次要终点
研究者
Frances R Levin
Director of Substance Use Disorder
National Institute on Drug Abuse (NIDA)