StudyVivitrol and implants2007
O'Malley 2007: Vivitrol in people already abstinent before the first shot
O'Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR. Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment
What it found
In 82 people who had stopped drinking for at least 4 days before their first shot, extended-release naltrexone 380 mg raised the rate of continuous abstinence to 32%, compared with 11% on placebo. The median time to a first drink was 41 days on the drug and 12 days on placebo.
- Continuous abstinence, 380 mg vs placebo
- 32% vs 11%
- Median days to first drink, 380 mg vs placebo
- 41 vs 12
- Responders, 380 mg vs placebo
- 70% vs 30%
- Heavy drinking days per month, 380 mg vs placebo
- 0.2 vs 2.9
What they tested
Extended-release naltrexone (sold as Vivitrol) is a shot given once a month. This paper looked at a subgroup from a larger trial: people who had voluntarily stopped drinking for 4 or more days before treatment began.
They received the 380 mg shot, a lower 190 mg shot, or a placebo (a dummy injection). Everyone also had counseling. The team compared a wide range of drinking outcomes between groups.
What they found
On the 380 mg shot, 32% stayed continuously abstinent through the end of the study, compared with 11% on placebo (P = 0.02). The median time to a first heavy drinking day was more than 180 days, versus 20 days on placebo.
Drinking days per month fell to a median of 0.7 versus 7.2 on placebo, 90% fewer. Heavy drinking days per month were 0.2 versus 2.9, 93% fewer.
More than twice as many people on 380 mg counted as responders, defined as no more than 2 heavy drinking days in any 28-day stretch: 70% versus 30%. A liver blood test linked to drinking (GGT) also improved more on the drug.
The 190 mg group, with only 26 people, had results that were generally in between, suggesting a higher dose had a bigger effect.
Limits
- This is a subgroup of one trial, not a new study. The site's guides count it as the same evidence as the main trial.
- The subgroup was small, and the 190 mg arm had just 26 people.
- People who can stop drinking on their own for several days before treatment may be more motivated than average, so the results may not apply to people still drinking.
What it means if you're considering naltrexone
Vivitrol is FDA-approved for people who can stop drinking before they start it. This analysis shows that, in that group, the shot was linked to much longer stretches without drinking, and the abstinence gap appeared with as few as 4 days off alcohol beforehand.
It doesn't tell us how the shot works for people who are still drinking at the first injection.
Frequently asked questions
Do you need to stop drinking before starting Vivitrol?
The shot is approved for people able to abstain before starting. In this analysis, people who had stopped for at least 4 days had 32% continuous abstinence on 380 mg vs 11% on placebo.
The paper
O'Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR. Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment. J Clin Psychopharmacol. 2007;27(5):507-512. doi:10.1097/jcp.0b013e31814ce50d
Read the paperdoi:10.1097/jcp.0b013e31814ce50d
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.