Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose

Официальное название

Randomized Clinical Trial of a 16 mg vs. 24 mg Maintenance Daily Dose of Buprenorphine to Increase Retention in Treatment Among People With Opioid Use Disorder

Обзор

The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg). The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).

Вмешательства

• Препарат Buprenorphine
  Buprenorphine in a highly effective treatment for opioid use disorder (OUD). Buprenorphine dose guidelines for OUD treatment were determined by clinical trials conducted in populations with a history of heroin use. However, fentanyl is changing the calculation of treatment, and optimal buprenorphine dosing for people who use fentanyl is unknown.

Первичные конечные точки

• Treatment Engagement [Срок оценки: six months post-randomization]

Вторичные конечные точки (2)

• Control of Opioid Cravings [Срок оценки: six months post-randomization]
• Treatment response based on use of non-prescribed opioids [Срок оценки: six months post-randomization]

Критерии участия

Критерии включения

• English-speaking
• Age 18 years-old or older
• Identified by the treating physician as having moderate to severe opioid use disorder (OUD)
• Initiating or continuing buprenorphine for treatment of opioid use disorder
• History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing fentanyl use during treatment)

Критерии исключения

• Previous enrollment in the trial
• Incarcerated or in police custody\*
• Pregnant
• Live outside of Rhode Island (RI)
• Unable to provide informed consent
• Allergy to Buprenorphine
• Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician \*Participants that become incarcerated/or in police custody during the study will be withdrawn.

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brown University — Providence

Публикации

• Chambers LC, Hallowell BD, Zullo AR, Paiva TJ, Berk J, Gaither R, Hampson AJ, Beaudoin FL, Wightman RS. Buprenorphine Dose and Time to Discontinuation Among Patients With Opioid Use Disorder in the Era of Fentanyl. JAMA Netw Open. 2023 Sep 5;6(9):e2334540. doi: 10.1001/jamanetworkopen.2023.34540. PMID 37721749
• Armeni K, Chambers LC, Peachey A, Berk J, Langdon KJ, Peterson L, Beaudoin FL, Wightman RS. Randomised clinical trial of a 16 mg vs 24 mg maintenance daily dose of buprenorphine to increase retention in treatment among people with an opioid use disorder in Rhode Island: study protocol paper. BMJ Open. 2024 Nov 9;14(11):e085888. doi: 10.1136/bmjopen-2024-085888. PMID 39521460

Идентификаторы

NCT: NCT06316830 · STUDY00000075

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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