Opioid Use DisorderPhase 2SHORENCT06639464
Semaglutide for Helping Opioid Recovery
A Phase 2 study testing Semaglutide in people with Opioid Use Disorder, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to 15 Sep 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking adults aged 18 or older
- DSM-5 diagnosis of severe opioid use disorder (OUD)
- Receiving buprenorphine ≥16 mg/day or methadone ≥70 mg/day for at least 30 days prior to enrollment
- Planning to continue buprenorphine or methadone treatment throughout the study
- Willing to bring buprenorphine prescriptions to visits for dose counts (if applicable)
- Willing to authorize communication between the study team and their MOUD prescriber via a 42 CFR release
Who cannot join
- Active psychosis, suicidality, homicidality, or psychiatric conditions impairing capacity to consent
- Current or lifetime history of an eating disorder
- BMI <21 kg/m²
- Current or lifetime diagnosis of Type 1 or Type 2 diabetes
- Personal or family history of medullary thyroid carcinoma or MEN2
- GLP-1 receptor agonist use within the past 3 months or anticipated use during the study
Show all 14Show fewer
- Myocardial infarction, stroke, unstable angina, or congestive heart failure within the past 90 days
- Persistently elevated BP (>160 mmHg systolic or >100 mmHg diastolic) during screening
- History of inflammatory bowel disease, bariatric surgery, idiopathic pancreatitis, or diabetic gastroparesis
- Liver function tests >3x the upper limit of normal or eGFR <30
- History of hypersensitivity or allergy to semaglutide
- Pregnancy or breastfeeding
- Anticipated participation in another investigational drug trial
- Any other condition that investigators determine may interfere with participation or pose a safety concern
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Joji Suzuki, MD, 617-732-5752, jsuzuki2@bwh.harvard.edu
Joji Suzuki, MD
About this study
Official title: 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.
Read the detailed description
Participants include N=46 men and women with DSM5 diagnosis of OUD who are newly initiating sublingual buprenorphine (SL-BUP), defined as within 60 days of enrollment. Only those participants who have attained stable SL-BUP dosing (i.e. no change in dose) for at least 30 days prior to enrollment and plan to remain on the SL-BUP for the duration of the trial will be eligible. Potential participants will be screened and enrolled only if they meet full inclusion criteria. After baseline procedures are complete, participants will be randomized to semaglutide or placebo. Following randomization, participants will be scheduled for thirteen weekly study visits. Each visit will last approximately 1 hour, except for study visits 1 (baseline), 7, and 14 (follow-up) which will take no more than 3 hours in order to conduct reward- and stress-related neurocognitive testing. At each visit, participants will complete vital signs, weight, urine toxicology testing, and a blood testing for glucose. Participants will also complete an assessment of adverse events and questionnaires probing secondary outcomes (i.e. anxiety and depression, suicidality, substance use, opioid withdrawal symptoms, craving questionnaire). Blood samples will be collected at the beginning, middle, and end of the study. At study visits 2-13, the weekly dose of semaglutide or placebo will be administered. Both participants and study staff (including raters) will be blinded to active drug vs. placebo. The medication will be purchased from the manufacturer, and stored in the BWH Investigational Drug Service (IDS). The IDS will then extract the semaglutide and draw the dose into syringes, which will be matching visually with the placebo doses.
- Conditions
- Opioid Use Disorder
- Being tested
- Semaglutide, Placebo
- Keywords
- semaglutide, opioid use disorder, buprenorphine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Ozempic
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.
PlaceboOther
Placebo syringes of saline and matching volume will be produced by IDS.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | This arm will receive saline placebo (n=23). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Weekly from baseline to end of study at 14 weeks
Secondary outcomes (19)
Visual Probe Task
A behavioral task to assess attentional bias. Opioid-related and neutral images will be used, different from the ones used for the cue-reactivity paradigm to limit habituation. A pair of images will appear on the left and right of the screen for either a short (200ms) or long (500ms) stimulus duration to assess automatic orientating and controlled attention processing, respectively. Image pairs will be replaced by a probe in the location of either the opioid-related or neutral image. The probe will remain until the participant responds to identify the probe orientation by pressing the response keys as quickly as possible. This task will yield reaction times for analysis.
Measured: Baseline, 6 weeks, and 13 weeks after baseline visit
Iowa Gambling Task (IGT)
A computerized task to measure risky decision making using four decks of cards (A, B, C, D). Participants are instructed to maximize profits. Cards from decks A and B earn more profits but lead to even higher occasional losses leading to net long-term losses, while decks C and D yield low profits but only low occasional losses resulting in a net long-term profit. The task will yield scores which are the sums of cards selected from decks A/B and decks C/D.
Measured: Baseline, 6 weeks, and 13 weeks after baseline visit
Monetary Choice Questionnaire (MCQ)
A self-report tool used to measure delayed discounting. Participants will be asked to pick one of the two choices given. Score calculated typically falls between 0.0 and 0.5, with smaller values indicating a lack of discounting and preference for delayed rewards and higher values indicating strong discounting and a preference for immediate rewards.
Measured: Baseline, 6 weeks, and 13 weeks after baseline visit
Clinical Opiate Withdrawal Scale (COWS)
Tool for assessing opioid withdrawal. Scale of 0-48, with a higher number meaning more severe withdrawal.
Measured: Weekly from baseline to end of study at 14 weeks
Patient Health Questionnaire (PHQ8)
A tool to assess depression symptoms. Scale of 0-24, with a higher score meaning more depression symptoms.
Measured: Weekly from baseline to end of study at 14 weeks
Generalized Anxiety Disorder (GAD7)
A standard tool to assess anxiety symptoms. Scale of 0-21 with a higher number indicating more anxiety.
Measured: Weekly from baseline to end of study at 14 weeks
WHO Quality of Life (WHOQOL-BREF)
A 26-item quality of life scale. Split into 5 domain scores: Overall Quality of Life and General Health (2-10), Physical Health (7-35), Psychological (6-30), Social relationships (3-15), and Environment (8-40). Higher scores indicate a higher quality of life.
Measured: Baseline and 13 weeks after baseline visit
Patient Rated Inventory of Side Effects (PRISE)
A self-report tool to qualify side effects. For each domain, the patient rates whether the symptoms are tolerable or distressing.
Measured: Weekly from 2 weeks after baseline to end of study at 14 weeks
Hemoglobin A1c
Hemoglobin A1c levels will be obtained via blood draw
Measured: At baseline and 13 weeks after baseline visit
Stanford Efficacy of treatment Scale (SETS)
An instrument for measuring patient outcome expectancy in clinical trials. Assesses positive and negative treatment expectations with 3 items each on 7-point Likert-scales from 0 'not agree at all' to 6 'fully agree'.
Measured: Baseline
Columbia suicide severity rating scale (C-SSRS)
A commonly used tool to assess suicidal ideation. The sum ranges from 2 to 25, with the higher number indicating more intense ideation.
Measured: Weekly from baseline to end of study at 14 weeks
Heart Rate
Heart rate measured in beats per minute (bpm).
Measured: Weekly from baseline to end of study at 14 weeks
Opioid Craving Scale
3-item measure of craving for opioids. Each item will be measured on a scale from 0-10 with 10 meaning stronger cravings.
Measured: Weekly from baseline to end of study at 14 weeks
Blood pressure
Blood pressure measured as (systolic)/(diastolic).
Measured: Weekly from baseline to end of study at 14 weeks
Blood sugar
Blood glucose
Measured: Weekly from baseline to end of study at 14 weeks
Assessment of blind
Measure of participant perception of whether they received the active study drug.
Measured: 6 weeks and 13 weeks after baseline visit.
Height
Height measured in meters.
Measured: Weekly from baseline to end of study at 14 weeks
Weight
Weight measured in kilograms.
Measured: Weekly from baseline to end of study at 14 weeks
Temporal Experience of Pleasure Scale (TEPS)
A tool to assess both anticipatory and consummatory reward. 18-item tool where each item is ranked from 1 ('very false for me') to 6 ('very true for me'). Items are averaged, with higher score indicate a stronger tendency to anticipate or experience pleasure.
Measured: At baseline and 13 weeks after baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start2 Jun 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joji Suzuki, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639464
- Sponsor's protocol ID
- 2024P002669
- Acronym
- SHORE
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided