A Multi-site Study to Disseminate and Evaluate Pharmacotherapy for Alcohol Dependence in Convicted Drinking Drivers
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Participation rate
研究概览
简要总结
This pilot study will explore the ways to link Ontario's remedial system for convicted drinking drivers to medical intervention, assess the receptiveness of the Back on Track client population to effective medical interventions, and assess the feasibility of a full-scale trial of pharmacotherapy for convicted drinking drivers.
详细描述
Many individuals with Alcohol Dependence do not receive treatment, despite effective treatments being available. A significant healthcare challenge is to find ways to bring people who have alcohol dependence into treatment programs. Drinking drivers are a group that has been shown to have high rates of alcohol dependence. In Ontario, all convicted drinking drivers who want to obtain a drivers license must complete Ontario's remedial program for convicted drinking drivers called Back on Track (BOT). In this program, those with more serious alcohol-related problems are assigned to a group treatment program. While it is likely that many of the individual in this group are experiencing alcohol dependence, currently there is no formal linkage to any medical services for these problems. In this study, the investigators will provide those in the BOT treatment group with information about a 24-week study assessing the effectiveness of naltrexone vs. placebo. This study will also assess the feasibility and level of interest among this population to obtain treatment for alcohol dependence.
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
- Double (Participant, Investigator)
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
- •Male or females - 18 years or older
- •Been convicted of drinking driving and allocated to either the education or the treatment group of the BOT program
- •Meet criteria for alcohol dependence using the SCID-IV
- •Consume more than 14 drinks (female) or 21 drinks (male) per week with a minimum of 2 heavy drinking days (≥ 4 drinks for females and ≥ 5 drinks for males) during a consecutive 30-day period within the 90 days prior to the baseline evaluation
- •Willing to receive pharmacotherapy for their alcohol dependence
- •Seeking abstinence from alcohol as their main goal
排除标准
- •History of other substance use (other than nicotine or cannabis) by DSM-IV criteria in the last 90 days (6 months for opiate abuse)
- •Positive urine drug screen
- •Psychiatric disorder requiring medication
- •Unstable medical condition requiring immediate investigation or treatment
- •Pregnancy or lactation
研究组 & 干预措施
Naltrexone
Drug: Naltrexone 50 mg/day for 24 weeks.All participants will receive medical intervention in the form of medical management (MM) which will be delovered by a trained health care professional.
干预措施: Naltrexone (Drug)
Control
Drug: Control Placebo (Lactose Monohydrate) for 24 weeks. All participants will receive medical intervention in the form of medical management (MM) which will be delivered by a trained health care professional.
干预措施: Control (Drug)
结局指标
主要结局
Participation rate
时间窗: 2 years
We will determine what percentage of subjects will participate in the preliminary medical screening and what percentage of subjects with a diagnosis of alcohol dependence will participate in the trial.
次要结局
- Effect of naltrexone on drinking patterns and drinking related measures(At baseline and six-month follow-up)
研究者
Bernard Le Foll
Principal Investigator
Centre for Addiction and Mental Health