The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is:
• Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids?
The investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids.
The participants will:
* Take semaglutide or a placebo every week for 12 weeks * Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires * Complete smartphone surveys sent at set times during the study
Age 18 to 75 years.
Body mass index (BMI) > 18.
Able and willing to provide informed consent prior to any study-related activities.
Current diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 Opioid Use Disorder (OUD) as per the Mini International Neuropsychiatric Interview (MINI) or per the site clinic diagnosis. Patients are eligible if they have a MINI > 3 ("moderate" or "severe" in the "Specify If" box in the Substance Use Disorder (Non-Alcohol) module for the category of opiates).
Age < 18 or > 75 years.
BMI <18.
Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.
Current use of glucagon-like peptide 1 receptor (GLP-1R) agonist.
Parallel
Semaglutide Pen Injector
DrugSemaglutide will be provided using an injection pen
Placebo
DrugPlacebo will be a dry needle stick; no substances will be injected
Number of participants being abstinent from illicit and nonprescribed opioids.
Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.
Number of participants being abstinent from illicit and nonprescribed opioids.
Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.
Number of participants being abstinent from illicit and nonprescribed opioids.
Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.
Number of participants being abstinent from illicit and nonprescribed opioids.
Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.
Self-reported opioid craving scores as assessed via smartphone surveys
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
Self-reported opioid craving scores as assessed via smartphone surveys
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
Self-reported opioid craving scores as assessed via smartphone surveys
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
Self-reported opioid craving scores as assessed via smartphone surveys
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
Click on the lead sponsor to view all of their trials.
Milton S. Hershey Medical Center
Lead sponsor
New York University
Collaborator
University of Maryland
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Stanley Street Treatment and Resources (SSTAR)
Collaborator
