Semaglutide for Helping Opioid Recovery

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether a medication called semaglutide can help people recovering from opioid use disorder (OUD) who are starting treatment with buprenorphine. Over 12 weeks, participants will receive either weekly injections of semaglutide or a placebo (a treatment that looks the same but has no active ingredients) to see how it affects their reactions to various drug-related cues, as well as to determine how safe and effective it is.

To be eligible for this trial, participants must be at least 18 years old, speak English, and have a recent diagnosis of severe opioid use disorder. They should have begun buprenorphine treatment within the last two months and be stable on a specific dose for at least 30 days. Participants will need to agree to share information about their treatment with the study team and bring their medication to each visit. This study is not yet recruiting, but it aims to help understand if semaglutide could be a beneficial part of recovery for those facing challenges with opioid use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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