GLP-1 + Naltrexone for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
This clinical trial tests a new treatment combination for individuals with alcohol use disorder. The treatment uses a glucagon-like peptide-1 agonist, which mimics a hormone involved in blood sugar regulation, and naltrexone, a medication that reduces alcohol cravings. The trial aims to determine if this combination can safely and effectively reduce alcohol cravings and consumption. Participants will receive either the actual treatment or a placebo during a 4-week in-patient program. Those who have been at Ashley Addiction Treatment center for at least a week and meet the criteria for alcohol use disorder may qualify. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
You may need to stop taking certain medications if they interact with the trial drugs, GLP-1 agonists or naltrexone. Specifically, medications like other GLP-1 agonists, insulin, and certain diabetes medications, as well as opioids and some other drugs, are not allowed during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that combining GLP-1 (Glucagon-Like Peptide-1) agonists with naltrexone may help treat alcohol use disorder. Studies have found that GLP-1 agonists can lower alcohol cravings and consumption. However, understanding their safety is important.
GLP-1 agonists are usually well-tolerated. Research on these treatments has consistently shown they help reduce symptoms of alcohol use. Some people might experience mild side effects like nausea or digestive issues, but serious side effects are rare.
The FDA has already approved naltrexone for treating alcohol use disorder, indicating its well-known safety profile. It is generally safe but can cause side effects like nausea or headaches in some people.
Overall, using GLP-1 and naltrexone together has shown positive results in reducing alcohol cravings while maintaining a good safety record. Participants should consider these factors when deciding to join a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining GLP-1 agonists with Naltrexone for alcoholism because these treatments work differently from the usual options. Most treatments for alcoholism, like disulfiram or acamprosate, focus on reducing craving or making alcohol consumption unpleasant. However, GLP-1 agonists are hormones that may help control alcohol consumption by regulating hunger and reward pathways in the brain, offering a novel mechanism of action. Naltrexone, on the other hand, is already used to curb cravings by blocking opioid receptors, and when paired with GLP-1, it could enhance effectiveness. This unique combination aims to tackle alcoholism from multiple angles, potentially offering a more comprehensive solution.
What evidence suggests that this trial's treatments could be effective for alcohol use disorder?
Research shows that certain medications called GLP-1 agonists can help reduce both the urge to drink alcohol and the amount consumed. Originally used to treat diabetes and obesity, studies suggest these medications might also lower alcohol consumption and related behaviors. In this trial, some participants will receive a combination of GLP-1 agonists and Naltrexone, a well-known treatment for alcohol use disorder. Research indicates that Naltrexone can reduce the risk of heavy drinking, decrease the number of binge drinking days, and lower the total amount of alcohol consumed. Together, GLP-1 agonists and Naltrexone offer promising options for reducing alcohol use.16789
Who Is on the Research Team?
Andrew S. Huhn, Ph.D.
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for individuals seeking treatment for alcohol use disorder, who may also experience violence related to alcohol use. Participants will be part of a 4-week in-patient program.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are enrolled in a 4-week in-patient treatment program for alcohol use disorder, randomized to receive either placebo + placebo, GLP-1 + placebo, or GLP-1 + naltrexone
Assessment
Participants attend study visits over a 14-day period to complete assessments of alcohol craving, alcohol demand, anhedonia, eating behaviors, and subjective effects, and provide vitals and biosamples
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Glucagon-Like Peptide-1 Agonist
- Naltrexone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor