Reynaud 2017 (ALPADIR): high-dose baclofen for alcohol dependence

What they tested

After alcohol detox, 320 adults with alcohol dependence were randomly assigned to baclofen (158 people) or a placebo, a dummy pill (162 people). The baclofen dose was raised over 7 weeks toward a target of 180 mg a day, held for 17 weeks, then lowered over 2 weeks before stopping.

The main measure was the share of people who didn't drink at all for 20 weeks in a row. The trial also tracked how much people drank and how strongly they craved alcohol.

What they found

Few people in either group stayed fully abstinent for 20 weeks: 11.9% on baclofen and 10.5% on placebo (OR 1.20; P = 0.618). The trial did not show that baclofen helps people stay off alcohol.

Drinking fell in both groups from the first month. At month 6, people on baclofen drank 10.9 g/day less than people on placebo, but the difference was not statistically significant (P = 0.095).

In people who drank at a high-risk level at the start, the gap at month 6 was 15.6 g/day in favour of baclofen, also not significant (P = 0.089).

Craving, measured with the Obsessive-Compulsive Drinking Scale, fell significantly more on baclofen (P = 0.017). The researchers saw no major safety concern.

Limits

• It tested one target dose, 180 mg a day, so it can't say how lower doses would do.
• The drinking results leaned toward baclofen but were not statistically significant, so they can't be taken as proof of a benefit.
• Everyone had been through detox first, so the results apply to people starting from abstinence, not to people still drinking.

What it means if you're considering naltrexone

For someone comparing alcohol medicines, ALPADIR shows that high-dose baclofen did no better than placebo at keeping people abstinent, though it may ease craving. Naltrexone wasn't part of this trial, so it says nothing directly about how the two compare. The VA/DoD guideline cited on this site found the evidence too weak to recommend for or against baclofen.