A treatment approach first tested in residential programs at Caron Treatment Centers is now available to consumers through telehealth. Quel Health announced on Sept. 8 that it has launched as a national telehealth company built around the use of GLP-1 receptor agonists for addiction, with care available in 41 states and Washington, D.C., and national coverage planned by the end of the year.
The gap between that offering and the regulatory record is what patients and families most need to understand. The FDA has not approved any GLP-1 medication for a substance use disorder, a point the company acknowledges in its launch announcement. As STAT reported, that means the drugs will be prescribed off-label.
Off-label prescribing is legal and common. According to the FDA's explanation of unapproved uses of approved drugs, clinicians may prescribe an approved drug for an unapproved use when they judge it medically appropriate for a patient. The company notes that gabapentin, topiramate, baclofen, ondansetron, bupropion, and mirtazapine are already used off-label in addiction medicine.
Quel describes itself as a management services organization that does not practice medicine. Licensed clinicians employed by affiliated practices provide care through video visits and app-based messaging.
Costs and Proven Alternatives
Because no GLP-1 is approved for addiction, insurance may not cover the drugs for that purpose. Anyone considering this route should ask for the full monthly cost of both the service and the medication before starting.
That matters because proven treatments exist. Buprenorphine and methadone reduce the risk of dying from an opioid overdose, and naltrexone and acamprosate have established evidence for alcohol use disorder. Behavioral treatments also work, especially alongside medication. These approved options remain underused, and a heavily marketed alternative could draw patients away from them.
The company says off-label prescribing requires a thorough evaluation and an informed consent discussion covering current evidence, contraindications, known and unknown risks, and treatment alternatives. Patients can use those items as a checklist when talking with any provider.
Where the Evidence Stands
The evidence is promising but incomplete. The company says more than 50 clinical trials of GLP-1s for addiction are registered on ClinicalTrials.gov. Randomized trials and large retrospective studies have found associations between these drugs and reduced substance use or craving, including published trials of semaglutide in alcohol use disorder and in adults who smoke cigarettes daily.
Related findings continue to emerge without settling the question. A Swedish nationwide study of 14,694 people with bipolar disorder who used diabetes medications, published in Acta Psychiatrica Scandinavica, found that semaglutide use was linked to fewer psychiatric hospitalizations, with a 21% lower risk. Liraglutide and dulaglutide showed no such link, suggesting any benefit may not extend across the drug class. Griffith University professor Mark Taylor, who led the research, said he hopes the findings will be tested in a randomized controlled trial. That study involved a different condition and does not show that GLP-1s treat addiction.
MedicalDaily previously reported that no GLP-1 is approved for addiction and that the decisive trials will not report results until 2027. What has changed is that a commercial service is now operating during that waiting period.
The Company's Case and Its Partner's Caution
Quel describes substance use disorder as one of a cluster of conditions produced by an environment engineered to capture attention and reward. Co-founder and CEO Marlene C. Lira, MPH, a substance use epidemiologist, said "our dopamine networks are sold to the highest bidder."
Chief medical officer Steven Klein, MD, PhD, a triple board-certified addiction medicine physician, noted that there are no FDA-approved medications for cannabis or stimulant use disorder and that options are "limited" for alcohol use disorder, which he said causes more than twice as many deaths each year as overdoses.
Caron Treatment Centers, named a founding strategic partner, added a caveat. Steven Wall, Caron's interim president and CEO, said that because GLP-1 use for substance use disorders "remains investigational and off-label," rigorous clinical oversight, informed consent, and continued research are essential.
Questions to Ask Before Starting
No one should stop an existing addiction medication to try a GLP-1. Anyone taking buprenorphine, methadone, naltrexone, or acamprosate should discuss any change with the clinician who manages that treatment.
Useful questions for any provider include whether the prescriber is licensed in the patient's state, what the evaluation involves, which medication and dose are proposed, what the total monthly cost will be, how side effects will be monitored, and whether approved medications for the specific disorder were considered first. Common GLP-1 side effects include nausea, vomiting, diarrhea, and constipation. Persistent vomiting, severe abdominal pain, or signs of dehydration need prompt medical attention.
People seeking treatment can call SAMHSA's National Helpline at 1-800-662-4357, a free, confidential referral service available 24 hours a day in English and Spanish.
Much remains unknown. It has not been established whether GLP-1 drugs reduce substance use enough to justify approval, which patients might benefit, or how safe the drugs are in this medically high-risk population. Eli Lilly is testing brenipatide, a once-monthly drug that targets GLP-1 and GIP receptors, in alcohol and opioid use disorder, with trial timelines extending into 2027 and 2028. MedicalDaily will report trial results, any FDA filing for a substance use indication, and any regulatory action on marketing claims.
Key Questions Answered
Is any GLP-1 approved for treating addiction?
No. The FDA has not approved any GLP-1 receptor agonist for a substance use disorder. Any such use is off-label.
Is off-label prescribing legal?
Yes. The FDA says clinicians may prescribe an approved drug for an unapproved use when they judge it medically appropriate for a patient.
Will insurance cover it for addiction?
Coverage for this use is uncertain because no GLP-1 is approved for it. Patients should ask for the total monthly cost before starting.
How strong is the evidence?
Promising but incomplete. Randomized and retrospective studies show encouraging associations, but larger trials are still underway, with key results expected starting in 2027.
What treatments already have established evidence?
Buprenorphine and methadone for opioid use disorder, and naltrexone and acamprosate for alcohol use disorder, along with behavioral treatment.
What side effects should patients watch for?
Nausea, vomiting, diarrhea, and constipation are common. Persistent vomiting, severe abdominal pain, or signs of dehydration need prompt medical attention.
Where can someone find treatment help now?
SAMHSA's National Helpline at 1-800-662-4357 offers free, confidential referrals to local treatment 24 hours a day in English and Spanish.
