Van den Brink 2013: nalmefene in people still drinking heavily

What they tested

Researchers pooled patients from two 6-month trials, ESENSE 1 and ESENSE 2, who drank at a high-risk level or above (more than 60 g a day for men, 40 g for women) both at screening and when treatment began. These were people who had not cut down on their own after the first assessment.

That gave 667 patients: 335 on nalmefene 18 mg and 332 on placebo, taken as needed. Everyone also had BRENDA, a counseling program aimed at motivation and taking the medicine. Drinking was measured with the Timeline Follow-back method, a day-by-day recall of drinking.

What they found

At month 6, people on nalmefene had 3.2 fewer heavy drinking days and drank 14.3 g a day less than people on placebo (P < 0.0001 for both).

Clinical status and liver test results improved more on nalmefene than on placebo.

Side effects, and dropouts because of side effects, were more common on nalmefene than on placebo.

Limits

• It's a subgroup analysis of two earlier trials, not a new trial designed for this group.
• The results apply only to people still drinking heavily at the start, not to everyone with alcohol dependence.
• More people on nalmefene dropped out because of side effects.

What it means if you're considering naltrexone

The site's nalmefene guide notes that Selincro is meant for adults who drink more than 60 g of alcohol a day (men) or 40 g (women), the same group studied here. For someone weighing naltrexone, the takeaway is narrow: in these nalmefene trials, the drug helped most in people who hadn't managed to cut down on their own. It doesn't test naltrexone itself.