Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial
The is a pilot, 12-week, double-blind, placebo-controlled, randomized trial of individuals with opioid use disorder (OUD) newly initiating buprenorphine to receive either weekly injections of semaglutide (n=23) or matching placebo (n=23). The primary aim is to determine the effects of semaglutide on cue-reactivity among individuals with OUD. The secondary aim is to assess the preliminary efficacy, safety, and tolerability of semaglutide for OUD.
• English speaking adults aged 18 and above
• DSM-5 diagnosis of opioid use disorder, severe
• Initiated sublingual buprenorphine (SL-BUP) treatment within 60 days of enrollment
• Attained stable dosing of SL-BUP of 16mg or greater for 30 days prior to enrollment
• Anticipating continuation of SL-BUP for the duration of the trial
• Agreeable with bringing SL-BUP prescription to visits to allow study team to conduct a dose count
• Willing to grant study team permission to communicate about SL-BUP treatment with community prescriber via completion of 42 CFR release
⁃ Individuals with any of the following will be excluded:
• DSM-5 diagnosis of any current substance use disorder excluding opioid, cannabis or tobacco
• Active psychosis, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent
• Any current or lifetime diagnosis of eating disorders
• BMI\<25mg/kg2
• Current or lifetime diagnosis of Type 1 or Type 2 diabetes
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
• Use of any GLP-1 agonist medications in the prior 3 months
• Anticipating receipt of any GLP-1 agonist medications during the trial
• History of angina pectoris, coronary heart disease, congestive heart failure, inflammatory bowel disease, chronic obstructive pulmonary disease, bariatric surgery, idiopathic pancreatitis, diabetic gastroparesis
• Liver function test greater than 3 times upper normal limit
• Renal impairment as indicated by eGFR of \<60
• History of hypersensitivity or allergy to semaglutide
• Pregnant or breastfeeding
• Anticipated to participate in a concurrent drug trial
• Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant