Pharmacotherapy for Alcohol Dependence in Convicted Drinking Drivers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-site Study to Disseminate and Evaluate Pharmacotherapy for Alcohol Dependence in Convicted Drinking Drivers

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: Naltrexone
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone<br>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. | Drug: Naltrexone<br>* 50 mg/day 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.<br>* Other names: Revia;|
| Placebo Comparator: Control<br>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. | Drug: Control<br>* 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.<br>* Other names: Placebo (Lactose Monohydrate);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation rate | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of naltrexone on drinking patterns and drinking related measures | Clinical trial data of naltrexone vs. placebo will assess the effectiveness of the study intervention on alcohol related outcomes. Outcomes will include percent days abstinent, time to first heavy drinking day and alcohol craving. BOT program data for all participants will also be assessed including measures of drinking behaviour and measures of other drug use and consequences resulting from substance use. Ministry of Transportation data will be used to determine the long term effect on relevant outcomes such as collisions and charges associated with alcohol use. | At baseline and six-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back on Track, convicted drinking drivers, naltrexone, alcohol dependence