Alcohol Dependence
Conditions
Keywords
Back on Track, convicted drinking drivers, naltrexone, alcohol dependence
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.
Interventions
DRUGNaltrexone
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.
DRUGControl
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.
Sponsors
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed