O'Malley 1992: naltrexone with coping skills or supportive therapy

What they tested

Ninety-seven people with alcohol dependence were randomly given naltrexone or a placebo (a dummy pill) for 12 weeks, without them or the staff knowing which. Each person was also randomly given one of two therapies that followed a written manual.

One was coping skills and relapse prevention therapy, which teaches specific skills for avoiding a relapse. The other was supportive therapy, which backed people's own efforts to stay abstinent without teaching specific skills.

What they found

Naltrexone was better than placebo on measures of drinking and alcohol-related problems, including abstinence rates, number of drinking days, relapse and how severe alcohol-related problems were.

The effect of the medicine depended on the therapy. The cumulative rate of abstinence was highest in people given naltrexone with supportive therapy.

Among people who started drinking during the trial, those on naltrexone with coping skills therapy were the least likely to relapse.

Limits

• With 97 people split four ways, each combination of pill and therapy had a small group.
• The abstract gives no percentages or effect sizes, so it's hard to judge from it how big the differences were.
• It lasted 12 weeks, and everyone got a structured therapy, so the results apply to naltrexone given alongside counselling.

What it means if you're considering naltrexone

This trial and Volpicelli's, both published in 1992, were the first placebo-controlled tests of naltrexone for alcohol, and the FDA approved the tablets for alcohol dependence in 1994. Its finding that naltrexone plus coping skills helped most once someone had a drink is part of the reasoning behind later targeted-use approaches, including the Sinclair Method.

For someone considering naltrexone, it suggests the kind of counselling that comes with it may shape what kind of benefit you see, though that comes from comparing small subgroups.