Semaglutide for Helping Opioid Recovery

NCT06639464 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2024P002669
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

semaglutide; opioid use disorder; buprenorphine

Outcome Measures

Primary Outcomes (2)

• Cue-induced Cravings for Opioids

  Cue-induced craving scores at study completion compared to baseline using a standard cue-reactivity paradigm utilizing visual cues. Cravings will be measured on a scale from 0-10 with 10 meaning extreme cravings.

  Baseline, 6 weeks, and 13 weeks after baseline visit

• Relapse to Illicit Opioid Use

  the primary outcome is proportion of participants who relapse to illicit opioids use at study completion, defined as the start of 4 consecutive opioid "use weeks" or at the start of 7 consecutive days of self-reported opioid use days. A "use week" is defined as any week in which participants self-report at least one day of illicit opioid use, provide a urine test positive for illicit opioids, or fail to provide a urine sample for testing. The study investigators will use Time-Line Follow Back (TLFB), a gold-standard method of evaluating substance use, as well as weekly urine toxicology screens.

  Weekly from baseline to end of study at 14 weeks

Secondary Outcomes (19)

• Visual Probe Task

  Baseline, 6 weeks, and 13 weeks after baseline visit

• Iowa Gambling Task (IGT)

  Baseline, 6 weeks, and 13 weeks after baseline visit

• Monetary Choice Questionnaire (MCQ)

  Baseline, 6 weeks, and 13 weeks after baseline visit

• Clinical Opiate Withdrawal Scale (COWS)

  Weekly from baseline to end of study at 14 weeks

• Patient Health Questionnaire (PHQ8)

  Weekly from baseline to end of study at 14 weeks

Study Arms (2)

Semaglutide

EXPERIMENTAL

This arm will receive semaglutide (n=23). All participants will initially receive 0.25mg for 4 weeks, and then as tolerated dose will be increased to 0.5mg for 4 weeks. Then as tolerated, the dose will be increased to 1.0mg for 4 weeks.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

This arm will receive saline placebo (n=23).

Other: Placebo

Interventions

Semaglutide DRUG

This intervention will consist of the FDA-approved dosing schedule, with terminal dosage based on manufacturer's recommendation to titrate to 1mg over 12 weeks. Participants will receive 0.25mg for the first 4 weeks, 0.5mg for the next 4 weeks, and 1.0mg for the final 4 weeks. IDS will extract semaglutide an draw the doses into syringes for matching placebo doses to also be produced and maintain blind.

Also known as: Ozempic

Semaglutide

Placebo OTHER

Placebo syringes of saline and matching volume will be produced by IDS.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Joji Suzuki

CONTACT

617-732-5752; jsuzuki2@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The IDS will perform both the randomization and blinding, and will be the only research staff that will remain unblinded. The IDS will extract the semaglutide and draw the dose into syringes, which will be made to match visually with the placebo saline doses. All other research staff will remain blinded for the duration of the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Addiction Psychiatry

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 15, 2024
• Study Start: June 2, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)