RECRUITING

Semaglutide for Helping Opioid Recovery

Conditions

Opioid Use Disorder semaglutide buprenorphine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-06

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06639464

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Joji Suzuki

CONTACT

617-732-5752

jsuzuki2@bwh.harvard.edu

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06

Study Completion Date2027-03

Study Record Updates

Study Start Date2025-06

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

semaglutide
opioid use disorder
buprenorphine

Additional Relevant MeSH Terms

Opioid Use Disorder