Clinical trial NCT01638377: Pharmacotherapy for Alcohol Dependence in Convicted Drinking Drivers
Official title: A Multi-site Study to Disseminate and Evaluate Pharmacotherapy for Alcohol Dependence in Convicted Drinking Drivers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Alcohol Dependence
Keywords: Back on Track
convicted drinking drivers
naltrexone
alcohol dependence
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participation rate
timeFrame: 2 years
Secondary outcomes:
measure: Effect of naltrexone on drinking patterns and drinking related measures
timeFrame: At baseline and six-month follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Bernard Le Foll, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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