Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation

Официальное название

Improving Buprenorphine Initiation Among Individuals With Opioid Use Disorder Using Fentanyl

Обзор

The goal of this pragmatic randomized controlled trial is to compare treatment outcomes of two strategies for initiating buprenorphine treatment (low-dose initiation and direct-to-inject) in adults with opioid use disorder (OUD) who use fentanyl. This study aims to: 1. Compare effectiveness of each strategy on treatment retention in a real world, clinical setting, and 2. Assess differences between strategies in patient-reported outcomes, including withdrawal symptoms, cravings, drug use, treatment satisfaction, and overall acceptability. Participants will: 1. Be randomized to initiate buprenorphine via a low-dose initiation or direct-to-inject protocol at an outpatient buprenorphine clinic, 2. Keep a diary of craving and withdrawal symptoms for the first 7 days after initiation, and 3. Visit the outpatient clinic 7, 30, and 90 days after initiation for urinary drug screen and follow-up surveys.

Вмешательства

• Препарат Injectable buprenorphine
  Starting dose (8-32mg) of long-acting injectable buprenorphine (Brixadi or Sublocade) on day 1, followed by monthly maintenance doses (e.g., 128mg Brixadi or 300mg Sublocade)
• Препарат Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
  Starting dose (0.5mg) of sublingual buprenorphine tablets in blister packs (Brixadi or Sublocade) on day 1, followed by 0.5-1.0mg daily increases in week 1 and maintenance dosing based on shared decision-making with provider

Первичные конечные точки

• Continuous retention in outpatient buprenorphine treatment by day 90 [Срок оценки: 90 days]
• Self-reported protocol satisfaction at day 7 [Срок оценки: 7 days]

Вторичные конечные точки (12)

• Per protocol and as-treated retention in outpatient buprenorphine treatment at day 90 [Срок оценки: 90 days]
• Successful buprenorphine initiation within first 7 days [Срок оценки: 7 days]
• Fentanyl use during days 1-7 determiend by urinary drug screen [Срок оценки: 7 days]
• Fentanyl use during days 8-30 determined by urinary drug screen [Срок оценки: 30 days]
• Fentanyl use during days 31-90 determined by urinary drug screen [Срок оценки: 90 days]
• Self-reported concurrent fentanyl use during days 1-7 [Срок оценки: 7 days]
• Self-reported concurrent fentanyl use during days 8-30 [Срок оценки: 30 days]
• Self-reported concurrent fentanyl use during days 31-90 [Срок оценки: 90 days]
• Self-reported number of days of fentanyl use in first 7 days [Срок оценки: 7 days]
• Self-reported number of days of concurrent fentanyl use during first 30 days [Срок оценки: 30 days]
• Self-reported number of days of concurrent fentanyl use during days 31-90 [Срок оценки: 90 days]
• Baseline withdrawal symptoms, measured with COWS [Срок оценки: 0 days]

Критерии участия

Критерии включения

• Age ≥ 18 years of age at Visit 1.
• Documentation of an OUD diagnosis as evidenced by meeting two or more of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) Criteria for Opioid Use Disorder
• Self-reported daily use of fentanyl ≥ 5 out of the past 7 days at baseline,
• Fentanyl-positive urine drug screening at baseline,
• Interest in stopping or reducing fentanyl use,
• Publicly insured through San Francisco Medicaid or Medicare and therefore able receive buprenorphine prescription dispensing through Community Behavioral Health Services (CBHS) Pharmacy

Критерии исключения

• Currently nursing, pregnant, or anticipating pregnancy in the next 6 months
• Methadone-positive urine drug screening at baseline
• Buprenorphine-positive urine drug screening at baseline
• Be unable to provide any locator or contact information at least one contact in addition to themselves
• Any pending legal action that could prevent participation in study activities
• Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data (e.g., acute psychosis), or cognitive impairment (e.g., dementia)

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

• San Francisco Outpatient Buprenorphine Induction Clinic — San Francisco

Публикации

• Noel M, Abbs E, Suen L, Samuel L, Dobbins S, Geier M, Soran CS. The Howard Street Method: A Community Pharmacy-led Low Dose Overlap Buprenorphine Initiation Protocol for Individuals Using Fentanyl. J Addict Med. 2023 Jul-Aug 01;17(4):e255-e261. doi: 10.1097/ADM.0000000000001154. Epub 2023 Feb 17. PMID 37579105
• Rosenwohl-Mack S, Suen LW, Logan AA, Peterson D, Snyder HR. Outpatient Initiation of 7-Day Injectable Buprenorphine: A Direct-to-Inject Case Series. Subst Use Addctn J. 2025 Oct;46(4):1064-1069. doi: 10.1177/29767342251330412. Epub 2025 Apr 4. PMID 40183345

Идентификаторы

NCT: NCT07469501 · 1K23DA060329-01 · 1K23DA060329-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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