Clinical trial NCT06639464: Semaglutide for Helping Opioid Recovery
Official title: Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Opioid Use Disorder
Keywords: semaglutide
opioid use disorder
buprenorphine
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Cue-induced Cravings for Opioids
timeFrame: Baseline, 6 weeks, and 13 weeks after baseline visit
measure: Relapse to Illicit Opioid Use
timeFrame: Weekly from baseline to end of study at 14 weeks
Secondary outcomes:
measure: Visual Probe Task
timeFrame: Baseline, 6 weeks, and 13 weeks after baseline visit
measure: Iowa Gambling Task (IGT)
timeFrame: Baseline, 6 weeks, and 13 weeks after baseline visit
measure: Monetary Choice Questionnaire (MCQ)
timeFrame: Baseline, 6 weeks, and 13 weeks after baseline visit
measure: Clinical Opiate Withdrawal Scale (COWS)
timeFrame: Weekly from baseline to end of study at 14 weeks
measure: Patient Health Questionnaire (PHQ8)
timeFrame: Weekly from baseline to end of study at 14 weeks
measure: Generalized Anxiety Disorder (GAD7)
timeFrame: Weekly from baseline to end of study at 14 weeks
measure: WHO Quality of Life (WHOQOL-BREF)
timeFrame: Baseline and 13 weeks after baseline visit
measure: Patient Rated Inventory of Side Effects (PRISE)
timeFrame: Weekly from 2 weeks after baseline to end of study at 14 weeks
measure: Hemoglobin A1c
timeFrame: At baseline and 13 weeks after baseline visit
measure: Stanford Efficacy of treatment Scale (SETS)
timeFrame: Baseline
measure: Columbia suicide severity rating scale (C-SSRS)
timeFrame: Weekly from baseline to end of study at 14 weeks
measure: Heart Rate
timeFrame: Weekly from baseline to end of study at 14 weeks
measure: Opioid Craving Scale
timeFrame: Weekly from baseline to end of study at 14 weeks
measure: Blood pressure
timeFrame: Weekly from baseline to end of study at 14 weeks
measure: Blood sugar
timeFrame: Weekly from baseline to end of study at 14 weeks
measure: Assessment of blind
timeFrame: 6 weeks and 13 weeks after baseline visit.
measure: Height
timeFrame: Weekly from baseline to end of study at 14 weeks
measure: Weight
timeFrame: Weekly from baseline to end of study at 14 weeks
measure: Temporal Experience of Pleasure Scale (TEPS)
timeFrame: At baseline and 13 weeks after baseline visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: