GLP-1R Agonist Treatment for Opioid Use Disorder

Launched by MILTON S. HERSHEY MEDICAL CENTER · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called semaglutide can help adults with opioid use disorder reduce their use of illegal opioids. The study will compare semaglutide to a placebo, which is a harmless substance that does not contain any active medication. Participants will receive either semaglutide or the placebo once a week for 12 weeks. During this time, they will visit the clinic weekly for urine tests and to answer questions about their mental health and drug use. They will also complete surveys on their smartphones at specific times throughout the study.

To be eligible for this trial, participants must be between 18 and 75 years old, have a body mass index (BMI) over 18, and currently be in outpatient treatment for opioid use disorder. They should have been using buprenorphine or methadone for at least two or four weeks, respectively, and have shown some use of opioids during that time. Participants must also be able to commit to the entire study duration, which is about 19 weeks. It's important to note that individuals with certain health conditions or who are pregnant or breastfeeding cannot participate. This trial aims to provide valuable information on whether semaglutide can be an effective treatment for those struggling with opioid addiction.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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).
• • Currently receiving outpatient treatment for OUD and at least 2 weeks on buprenorphine (BUP) or 4 weeks on methadone at the study site and/or at an associated clinic at the time of enrollment.
• • Have at least 1 urine test positive for opioids after 2 weeks on BUP or 4 weeks on methadone.
• • Have positive self-reporting of opioid use after 2 weeks on BUP or 4 weeks on methadone.
• • If anatomically capable of becoming pregnant and of childbearing age, is not pregnant (confirmed) or breastfeeding at the time of enrollment and agrees to use a medically accepted method of birth control or to abstain from sexual intercourse while in the study.
• • Able to read and communicate in English to the level required to accept standard care and complete all study requirements.
• • Able and willing to engage/adhere to the entirety of the study protocol (19 weeks).
• • Not currently a prisoner.
• Exclusion Criteria:
• • 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.
• • History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to semaglutide or another GLP-1R agonist.
• • Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome Type 2 (MEN 2) or thyroid nodule.
• • Type 1 diabetes or history of diabetic ketoacidosis.
• • Type 2 diabetes mellitus or current use of a dipeptidyl peptidase-4 (DPP-4) inhibitor.
• • Past 30-day use of Sincalide, Sulfonylureas, insulin and insulin products or other medications that may interact with semaglutide.
• • Hypoglycemia on intake visit (blood glucose \< 60 mg/dL).
• • End-stage renal failure, on dialysis, or glomerular filtration rate (GFR) \<30 mL/min per 1.73 square meters or previous renal transplant.
• • End stage liver disease or previous liver transplant.
• • Current or past diagnosis of pancreatitis, gastroparesis, or other severe gastrointestinal (GI) disease.
• • Current or past diagnosis of gallbladder disease or gallstones.
• • Serious cardiovascular disease within the past 6 months (e.g. uncontrolled hypertension, heart failure, significant cardiac arrhythmias, myocardial infarction, presence of angina pectoris, symptomatic coronary artery disease, deep vein thrombosis, pulmonary embolism, second- or third-degree heart block, mitral valve or aortic stenosis, hypertrophic cardiomyopathy, stroke).
• • Severe co-occurring psychiatric disorder (e.g., bipolar disorder, psychotic disorder, schizophrenia), and/or history or evidence of organic brain disease or dementia that would compromise safety or compliance with the study protocol in the opinion of the site principal investigator (PI) and/or physician. As there is no specific scale that determines this, this will include the Site PI/physician determining if the potential participant shows consistency in decision making and if they are alert and oriented to time, date, day and location.
• • Significant risk of suicide requiring a different/higher level of care, according to the clinical judgment of the study physician or site principal investigator, or history of suicide attempts within the past 1 year, unless participation is cleared by clinician assessment and/or judgment. A Columbia-Suicide Severity Rating Scale (C-SSRS) indicating a history of suicide attempts within the past year, or active suicidal ideation within the past 1 month, will qualify as significant risk of suicide.
• • Treatment with any investigational drug in the one month preceding the study.
• • Any contraindication to both methadone and BUP.
• • Any contraindication to a GLP-1R agonist.
• • Previous randomization for participation in this trial.
• • Any other condition at screening that precludes safe participation in the trial in the judgment of the site PI or study physician.
• • Plans for travel outside of the local area over the 19 weeks (1 week of baseline, 12 weeks of medication, 1 week wash-out, and follow-up after a further 28 days) that would interfere with visits during the study period or other logistic factors that would make it difficult to commit to the entire duration of study.
• • Currently a prisoner.