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Randomized trialSinclair Method and as-needed use2009Landmark study

Kranzler 2009: targeted naltrexone for people cutting down

Kranzler HR, Tennen H, Armeli S, et al. Targeted naltrexone for problem drinkers

What it found

Men who took naltrexone 50 mg only before situations they saw as high-risk drank less per day at week 12 than people in the other groups, in a 12-week trial of 163 heavy drinkers trying to cut down. Women did not show the same benefit on that main measure, and the authors said stronger medicines or extra strategies are needed.

People in the trial
163
Share who were men
58.3%
Trial length
12 weeks

What they tested

Participants got naltrexone 50 mg or a placebo (a dummy pill). Some were told to take it every day, others to take it only in situations they identified as high-risk for heavy drinking. Everyone's goal was to drink within safe limits, not to stop completely.

Each day, participants phoned an automated system to report how much they drank and whether they took their medicine. The researchers checked whether results differed between men and women.

What they found

On the main measure, average drinks per day, men in the targeted naltrexone group drank significantly less at week 12 than people in the other groups. This advantage was seen in men, not women.

On drinks per drinking day, a secondary measure, the targeted naltrexone group drank significantly less than the other groups during week 12, and this time the effect didn't depend on sex.

The authors wrote that the results support a targeted approach for heavy drinkers, particularly men, but argue for adding other strategies or using more effective medicines than naltrexone to get a bigger effect.

Limits

  • The main benefit showed up in men only, and the trial wasn't large enough to say much about each subgroup.
  • Results are reported at week 12, so the abstract says nothing about what happens after treatment ends.
  • Drinking was self-reported by phone, which depends on people answering honestly every day.

What it means if you're considering naltrexone

This trial was set up to repeat an earlier finding that taking naltrexone ahead of risky situations helps people cut down. It supports the idea that as-needed naltrexone can reduce drinking, especially in men, which is relevant to anyone considering a targeted or Sinclair-style approach.

The authors themselves were cautious: they described the effect as needing a boost from other strategies or better medicines. The site's guide on dosing lists this trial as one of two US tests of targeted use.

Frequently asked questions

Did targeted naltrexone work for women in Kranzler 2009?

On the main measure, drinks per day, only men in the targeted naltrexone group did better. On drinks per drinking day, the targeted group did better with no difference by sex.

What does targeted naltrexone mean?

In this trial it meant taking naltrexone 50 mg only in situations people identified as high-risk for heavy drinking, rather than every day.

The paper

Kranzler HR, Tennen H, Armeli S, et al. Targeted naltrexone for problem drinkers. J Clin Psychopharmacol. 2009;29(4):350-357. doi:10.1097/JCP.0b013e3181ac5213

Read the paperdoi:10.1097/JCP.0b013e3181ac5213

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.