StudySinclair Method and as-needed use2014Landmark study
Sinclair 2014: how well people stuck to as-needed nalmefene
Sinclair J, Chick J, Sørensen P, Kiefer F, Batel P, Gual A. Can alcohol dependent patients adhere to an 'as-needed' medication regimen?
What it found
Across 1,276 patients in two nalmefene trials, 68% of those on nalmefene stuck to the as-needed regimen on at least 80% of study days (78% of those who finished). People took nalmefene on about half of study days, and how often they took it matched how they drank before the trial.
- Nalmefene patients adherent on at least 80% of days
- 68%
- Same measure, study completers only
- 78%
- Share of days medicine taken, nalmefene vs placebo
- 52.8% vs 64.5%
What they tested
The authors pooled medication-use data from two randomized, double-blind, placebo-controlled trials of nalmefene for alcohol dependence, 1,276 patients in all. The aim was to see whether taking a drug only as needed is a practical approach for people seeking help with their drinking.
Adherence was defined as either drinking and taking the medicine that day, or not drinking at all, with or without the medicine.
What they found
Nalmefene was taken on about half of study days (52.8%), and placebo was taken more often (64.5%).
In each group, how often people took the tablet seemed to follow their needs: intake was linked to their drinking pattern before the trial.
68% of nalmefene patients, and 78% of those who completed the study, followed the as-needed regimen on at least 80% of study days.
The authors concluded that as-needed use is a feasible, patient-centred approach that involves people in actively managing their drinking.
Limits
- It's a secondary analysis of medication-use data. It doesn't test whether as-needed dosing works better than daily dosing.
- Days without drinking counted as adherent even if no tablet was taken, which is a generous definition of sticking to the plan.
- It covers nalmefene, not naltrexone.
What it means if you're considering naltrexone
The Sinclair Method means taking naltrexone before drinking, only on drinking days. A common doubt about any as-needed plan is whether people will remember to take the pill when it counts. This analysis suggests most people in two nalmefene trials could follow that kind of schedule.
It used nalmefene, a close cousin of naltrexone, and it measured whether people followed the regimen, not how well the regimen worked.
Frequently asked questions
Do people actually take as-needed medication when they drink?
In this pooled analysis, 68% of nalmefene patients followed the as-needed regimen on at least 80% of study days. Among those who finished the trials, it was 78%.
The paper
Sinclair J, Chick J, Sørensen P, Kiefer F, Batel P, Gual A. Can alcohol dependent patients adhere to an 'as-needed' medication regimen? Eur Addict Res. 2014;20(5):209-217. doi:10.1159/000357865
Read the paperdoi:10.1159/000357865
We wrote this page from the paper's published abstract, and the study's numbers here come from there. Updated October 17, 2026.
Medical disclaimer
This page is for information only and is not medical advice, diagnosis, or treatment. Don't start, stop, or change any medicine — including naltrexone — without your prescriber. Naltrexone must not be used by people taking opioid pain medicines, people dependent on opioids, or people in opioid withdrawal (FDA label). In an emergency call 911; for crisis support call or text 988. Full medical disclaimer.