Pharmacotherapy for Alcohol Dependence in Convicted Drinking Drivers

Center for Addiction and Mental Health (CAMH)

Status and phase: Terminated; Phase 4

Conditions: Alcohol Dependence

Treatments: Drug: Naltrexone; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01638377

079/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups, including a placebo group

Naltrexone

Experimental group

Description:

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.

Treatment:

Drug: Naltrexone

Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Control