Semaglutide for Helping Opioid Recovery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Semaglutide
  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.
• Другое Placebo
  Placebo syringes of saline and matching volume will be produced by IDS.

Первичные конечные точки

• Cue-induced Cravings for Opioids [Срок оценки: Baseline, 6 weeks, and 13 weeks after baseline visit]
• Relapse to Illicit Opioid Use [Срок оценки: Weekly from baseline to end of study at 14 weeks]

Вторичные конечные точки (12)

• Visual Probe Task [Срок оценки: Baseline, 6 weeks, and 13 weeks after baseline visit]
• Iowa Gambling Task (IGT) [Срок оценки: Baseline, 6 weeks, and 13 weeks after baseline visit]
• Monetary Choice Questionnaire (MCQ) [Срок оценки: Baseline, 6 weeks, and 13 weeks after baseline visit]
• Clinical Opiate Withdrawal Scale (COWS) [Срок оценки: Weekly from baseline to end of study at 14 weeks]
• Patient Health Questionnaire (PHQ8) [Срок оценки: Weekly from baseline to end of study at 14 weeks]
• Generalized Anxiety Disorder (GAD7) [Срок оценки: Weekly from baseline to end of study at 14 weeks]
• WHO Quality of Life (WHOQOL-BREF) [Срок оценки: Baseline and 13 weeks after baseline visit]
• Patient Rated Inventory of Side Effects (PRISE) [Срок оценки: Weekly from 2 weeks after baseline to end of study at 14 weeks]
• Hemoglobin A1c [Срок оценки: At baseline and 13 weeks after baseline visit]
• Stanford Efficacy of treatment Scale (SETS) [Срок оценки: Baseline]
• Columbia suicide severity rating scale (C-SSRS) [Срок оценки: Weekly from baseline to end of study at 14 weeks]
• Heart Rate [Срок оценки: Weekly from baseline to end of study at 14 weeks]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT06639464 · 2024P002669

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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