Pharmacotherapy for Alcohol Dependence in Convicted Drinking Drivers

Phase 4

Terminated

• Conditions: Alcohol Dependence
• Interventions: Drug: Naltrexone; Drug: Control

• Registration Number: NCT01638377
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-11
• Study Start: 2012-08
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone	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.
Control	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.

Primary Outcome Measures

Name	Time	Method
Participation rate	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.

Secondary Outcome Measures

Name	Time	Method
Effect of naltrexone on drinking patterns and drinking related measures	At baseline and six-month follow-up	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.

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada