Semaglutide for Opioid Addiction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if semaglutide (also known as Ozempic, Wegovy, or Rybelsus) can help reduce illegal opioid use in adults receiving outpatient treatment for opioid addiction. Participants will receive either semaglutide or a placebo (a treatment with no active drug) once a week for 12 weeks. Eligible participants should currently be undergoing treatment with buprenorphine or methadone and still show signs of opioid use, such as positive urine tests. As a Phase 2 trial, this research focuses on measuring semaglutide's effectiveness in an initial, smaller group, offering a chance to contribute to important findings in opioid addiction treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain medications like GLP-1R agonists, DPP-4 inhibitors, or have used Sincalide, Sulfonylureas, insulin, or similar medications in the past 30 days.
Is there any evidence suggesting that semaglutide is likely to be safe for humans?
Research has shown that semaglutide is generally safe for people. In one study with over 33,000 participants, those taking semaglutide had a much lower risk of opioid overdose compared to those who didn't take it, suggesting it is safe to use alongside treatments for opioid addiction.
Another study found that semaglutide helped reduce alcohol cravings, indicating it might be safe and effective for treating addiction-related cravings. Additionally, a study of over 200,000 patients using diabetes medications, including semaglutide, showed a 32% lower risk of medical problems, further suggesting its general safety.
While specific data on side effects for people with opioid use disorder is lacking, semaglutide's use in other conditions suggests it is relatively safe. However, as this is a Phase 2 trial, more safety data will be collected to confirm these findings.12345Why do researchers think this study treatment might be promising?
Researchers are excited about semaglutide for opioid addiction because it offers a fresh approach compared to traditional treatments like methadone or buprenorphine, which primarily work by interacting with opioid receptors. Semaglutide, originally developed for diabetes and weight management, works differently by mimicking the hormone GLP-1, which can influence brain pathways related to addiction. This new mechanism of action could potentially reduce cravings and support recovery in a novel way. Additionally, the once-weekly administration of semaglutide is convenient and could improve adherence for individuals seeking treatment.
What evidence suggests that semaglutide might be an effective treatment for opioid addiction?
Research has shown that semaglutide, a drug often used for diabetes, might help with opioid addiction. One study found that people with opioid addiction who took semaglutide had a 40% lower chance of overdosing on opioids. Another study reported a reduced risk of opioid overdose over a year for those using semaglutide. These findings suggest that semaglutide could lower opioid use and related dangers. In this trial, participants in the investigational group will receive semaglutide, while those in the control group will receive a placebo. Although its use for addiction treatment is still under investigation, early results appear promising.678910
Who Is on the Research Team?
Jennifer Nyland, PhD
Principal Investigator
Milton S. Hershey Medical Center
Are You a Good Fit for This Trial?
This trial is for adults in outpatient treatment for opioid use disorder who are currently on buprenorphine or methadone. Participants must be willing to take weekly injections, attend regular clinic visits for drug screening and health checks, and complete mental health assessments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants complete a baseline evaluation and are randomly assigned to semaglutide or placebo control arms
Treatment
Participants receive semaglutide or placebo once per week for 12 weeks, with weekly clinic visits for urine drug screening, pregnancy testing, vital signs, and questionnaires
Wash-out
Participants discontinue semaglutide or placebo and are observed for an additional week
Follow-up
A final follow-up visit takes place 5 weeks after the last treatment visit to monitor safety and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Semaglutide
Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Obesity
- Type 2 diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Patricia Sue Grigson
Lead Sponsor
Milton S. Hershey Medical Center
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
University of Maryland
Collaborator
New York University
Collaborator