Naltrexone for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness and safety of naltrexone for individuals aiming to reduce or stop alcohol consumption during "Dry January." The goal is to determine if taking naltrexone as needed helps participants adhere to their plan to drink less or abstain entirely. The trial will also assess the medication's impact on mood, cravings, and overall quality of life. It suits those planning to cut back or stop drinking in January 2026, who do not have a serious alcohol use disorder, and can visit a study site in Boston. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving medications for treating alcohol use disorder like naltrexone, acamprosate, or disulfiram.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that naltrexone is generally safe for individuals managing alcohol dependence. One study found that taking 50 mg of naltrexone daily did not cause significant liver damage, addressing a common concern with medications. Another study demonstrated that naltrexone is safe even for individuals with liver issues, such as cirrhosis. The FDA has already approved naltrexone for other uses, indicating it has passed some safety checks. Overall, the safety information appears promising for those considering naltrexone to help reduce or stop drinking.12345
Why do researchers think this study treatment might be promising?
Naltrexone is unique because it targets the brain's opioid receptors, helping to reduce cravings and the rewarding effects of alcohol, which is different from many other treatments for alcoholism. Unlike traditional options like disulfiram or acamprosate, which have different mechanisms, naltrexone directly blocks the euphoria associated with drinking. Researchers are excited about this treatment because it can be taken as needed, giving individuals more flexibility and control over managing their cravings, potentially leading to better adherence and outcomes.
What evidence suggests that naltrexone might be an effective treatment for reducing alcohol consumption?
Research has shown that naltrexone helps people manage their alcohol use. In studies, participants taking naltrexone achieved 15% better results than those who did not. It reduces the number of drinking days and lessens cravings for alcohol. Naltrexone also lowers the risk of returning to heavy drinking by making alcohol less enjoyable, thus reducing its temptation.13567
Who Is on the Research Team?
Joji Suzuki, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for individuals who don't have alcohol use disorder but want to cut down or stop drinking during Dry January. They should be interested in using naltrexone as needed or daily to help with this goal. Specific eligibility criteria are not provided, so general interest and commitment to reducing alcohol intake seem key.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 31-day supply of 50mg oral naltrexone to take as needed during Dry January
Follow-up
Participants are monitored for safety, adherence, and changes in alcohol use patterns, with a qualitative interview exploring experiences using naltrexone
What Are the Treatments Tested in This Trial?
Interventions
- Naltrexone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor