Randomized trialSinclair Method and as-needed use2001Landmark study

Heinälä 2001: targeted naltrexone without detox first

Heinälä P, Alho H, Kiianmaa K, Lönnqvist J, Kuoppasalmi K, Sinclair JD. Targeted use of naltrexone without prior detoxification in the treatment of alcohol dependence: a factorial double-blind, placebo-controlled trial

What it found

With coping skills therapy, 27% of people on naltrexone had no relapse to heavy drinking over 32 weeks, compared with 3% on placebo. In the groups given supportive therapy instead, naltrexone was not better than placebo.

No heavy-drinking relapse, naltrexone plus coping: 27%
No heavy-drinking relapse, placebo plus coping: 3%
Dropout in the first 12 weeks: 16.5%
People in the trial: 121

What they tested

Researchers in Finland enrolled 121 outpatients with alcohol dependence who had not stopped drinking. Each was randomly given cognitive coping skills therapy (67 people) or supportive therapy (54), and naltrexone 50 mg a day (63) or placebo (58). Neither patients nor staff knew who had the real drug.

For the first 12 weeks people took their pill every day. For the next 20 weeks they took it only when they craved alcohol, an approach called targeted medication.

What they found

After 12 weeks of daily pills, the naltrexone plus coping skills group had the best outcome and the placebo plus coping skills group the worst. That difference held through the 20 weeks of targeted use.

Naltrexone was not better than placebo in the supportive therapy groups. In the coping skills groups it had a significant effect: 27% of people on naltrexone had no relapses to heavy drinking across all 32 weeks, against 3% on placebo.

The dropout rate was 16.5% in the first 12 weeks and about twice that by the end. Groups didn't differ in how many finished or how often they attended therapy.

Limits

It was a single-center trial of 121 people, and the benefit showed up only in the coping skills groups, which are smaller subgroups.
Everyone switched to as-needed dosing after 12 weeks, so the trial didn't compare targeted use with carrying on daily.
Dropout roughly doubled after the first 12 weeks, so fewer people were left to judge the as-needed phase.
John David Sinclair, who developed the Sinclair Method, was one of the authors.

What it means if you're considering naltrexone

This is one of the main trials behind the Sinclair Method. It suggests naltrexone can be started without detox first, and that taking it only when craving can keep up the drop in heavy drinking after a period of daily use, at least alongside coping skills therapy.

It isn't proof that naltrexone helps with any kind of support: in this trial it did nothing extra alongside supportive therapy. Targeted use is also off-label in the US.

Frequently asked questions

Do you need to stop drinking before starting naltrexone?

Not in this trial. People were still drinking when they started, and the authors concluded detoxification was not required. The benefit appeared in people who also had coping skills therapy.

Does taking naltrexone only when craving work?

In this trial, after 12 weeks of daily use, taking naltrexone only when craving for 20 more weeks kept up the reduction in heavy drinking in the coping skills group.

The paper

Read the paper doi:10.1097/00004714-200106000-00006

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.