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Medical Daily
Medical Daily
Cole Mercer

No GLP-1 Is Approved for Addiction and the Trials That Could Change That Do Not Report Until 2027

Patients keep reporting that alcohol lost its pull, that cigarettes stopped interesting them, that cravings quieted, all while taking a drug prescribed for diabetes or weight. Researchers have taken those reports seriously enough to build a research program around them. What has not happened, and will not happen soon, is approval.

No GLP-1 medication is approved by the Food and Drug Administration for alcohol use disorder, opioid use disorder, nicotine dependence, or any other addiction. Any use for cravings is off-label. The trials designed to settle whether these drugs actually work for addiction are running now, and the first decisive readouts are not expected until 2027.

That gap between a compelling signal and an answer is where patients and families currently sit, and it is worth understanding what fills it.


Evidence That Exists Today and What Grade It Earns

The research base sorts into three tiers of very different strength.

Preclinical work is the largest and least conclusive. Animal studies have shown reduced self-administration of alcohol, cocaine, fentanyl, heroin, and nicotine after GLP-1 receptor activation, with effects traced to reward-related brain regions. Consistent, mechanistically coherent, and not a basis for treating people.

Observational studies in humans come next. Large analyses of health records have linked GLP-1 use to lower rates of new and recurrent alcohol use disorder, fewer alcohol-related hospitalizations, reduced opioid overdose events, and lower substance-related mortality. These are associations. People prescribed GLP-1 drugs differ from those who are not in ways that statistical adjustment cannot fully resolve.

Randomized trials are the smallest tier and the mixed one. A phase 2 trial of 48 non-treatment-seeking adults found weekly low-dose semaglutide reduced alcohol consumed in a laboratory setting and reduced weekly craving over nine weeks, though not every consumption measure moved. A separate randomized trial of exenatide did not significantly reduce heavy drinking overall, with benefit appearing only in an exploratory subgroup with obesity. Most completed human trials before that semaglutide result had negative primary outcomes.

Evidence outside alcohol is thinner still. For opioid use disorder, published data have been largely limited to animal models. For cocaine and nicotine, small clinical studies and preclinical work suggest possible benefit, with human data limited.


The Pipeline That Will Decide This

Addiction has become one of the fastest-growing areas of GLP-1 research, with studies now running across alcohol, nicotine, opioid, cocaine and methamphetamine use disorders.

The largest industry program belongs to Eli Lilly, which is developing brenipatide, an investigational dual GLP-1 and GIP receptor agonist. According to BioSpace, the company has two phase 3 trials running in alcohol use disorder, a phase 2 study in tobacco relapse, and a separate phase 2 study testing the drug alongside other medicines in people with opioid use disorder. A company spokesperson said those trials are expected to be completed in 2027 and 2028.

The opioid study, registered as RENEW-Op-1, is testing brenipatide as an adjunct to transmucosal buprenorphine, with or without naloxone, in people in early recovery. A separate phase 2 study in bipolar disorder is also recruiting.

The opioid work carries particular weight for a specific reason. Speaking at the American Psychiatric Association annual meeting, addiction psychiatrist Joji Suzuki noted that if brenipatide were eventually approved for opioid use disorder, it would be the first new pharmacotherapy for that indication since buprenorphine, approved more than two decades ago, according to Psychiatric Times. Researchers are testing GLP-1 drugs alongside existing medications rather than as replacements.

Lorenzo Leggio, an addiction researcher at the National Institutes of Health, told BioSpace that more and larger studies are needed to determine whether these drugs really work as addiction treatments. "This is the part that we're still missing," he said.


The Cost of Treating a Signal as a Treatment

Off-label prescribing for cravings is already reported, which is precisely why researchers argue the trials are urgent rather than academic.

The practical risk is not that GLP-1 drugs are uniquely dangerous. It is displacement. Effective treatments for alcohol and opioid use disorder already exist and are badly underused. Buprenorphine and methadone substantially reduce opioid overdose death. Naltrexone and acamprosate have established evidence in alcohol use disorder. Behavioral treatments work, particularly in combination. Someone who postpones starting one of those while waiting for a GLP-1 option is trading a proven intervention for an unproven one.

GLP-1 drugs also carry real side effects, including gastrointestinal effects that lead some patients to stop. They interact with other medications through delayed gastric emptying, which matters for drugs with narrow therapeutic windows such as lithium.

Cost and access are unresolved. Even where these drugs are covered for diabetes or obesity, no insurer covers them for addiction, because no such indication exists. Nothing about the current evidence changes what a pharmacy will pay for.


Reasonable Steps While the Science Matures

Nobody should start, stop, or change a prescription based on this research without talking to a qualified clinician. That includes people already taking a GLP-1 who notice reduced cravings, which is not a reason to discontinue other treatment.

Anyone struggling with alcohol, opioids, or nicotine should not wait. Approved medications and behavioral therapies are available now, and a physician or addiction specialist can discuss which fit a person's situation. The federal SAMHSA helpline at 1-800-662-4357 provides free, confidential referrals around the clock.

People interested in the research itself can search ClinicalTrials.gov for studies that are enrolling. Trial participation is one legitimate route to access an investigational drug, and it comes with monitoring that off-label prescribing does not.

Readouts from the academic phase 2 semaglutide studies are expected first, with the larger industry results beginning to land in 2027. Those trials, not the anecdotes, will determine whether this becomes a treatment.


Key Questions Answered

Can I get a GLP-1 drug prescribed for addiction? Not as an approved treatment. No GLP-1 medication is FDA-approved for any substance use disorder. Any such use is off-label, and no insurer covers it for that purpose.

How strong is the evidence right now? Mixed and incomplete. Animal studies are consistent; observational human data show associations; and randomized trials are few, small, and have often had negative primary outcomes. One recent semaglutide trial in alcohol use disorder was positive on several measures.

When will there be a real answer? Eli Lilly has said its brenipatide trials are expected to be completed in 2027 and 2028. Several academic phase 2 studies are due to report sooner.

What is brenipatide? An investigational Eli Lilly compound targeting GLP-1 and GIP receptors, in phase 3 trials for alcohol use disorder and phase 2 trials for tobacco relapse, opioid use disorder, and bipolar disorder. It is not approved for anything and is not available outside clinical trials.

Should I wait for this instead of starting treatment now? No. Approved medications and behavioral therapies for alcohol and opioid use disorder exist and work. Delaying proven treatment for an unproven one carries real risk, particularly with opioids.

I take a GLP-1, and my cravings dropped. What does that mean? It is consistent with what researchers are studying, but it is not a diagnosis or a treatment plan. Discuss it with your clinician rather than adjusting any medication on your own.

Where can someone get help today? A physician or addiction specialist can review options. The SAMHSA National Helpline at 1-800-662-4357 offers free, confidential treatment referrals 24 hours a day.

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