RECRUITING

Semaglutide for Helping Opioid Recovery

Description

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.

Conditions

Opioid Use Disorder
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Related Conditions:

Opioid Use Disorder

Study Overview

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Study Details

Study overview

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.

Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial

Semaglutide for Helping Opioid Recovery

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Study Record Dates

2027-03