Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

Официальное название

A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder

Обзор

This study will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (MOUD).

Подробное описание

The study is a 12-week, randomized, active-control, open-label, early phase II effectiveness trial of telemedicine treatment using sublingual buprenorphine as compared to in person clinic treatment with sublingual buprenorphine for outpatients seeking treatment for opioid use disorder (OUD). This telehealth protocol serves as a model of the integration of evidence-based practices in medication for opioid use disorder (MOUD) and could be used by non addiction specialists at scale. The primary outcome will be time to dropout. Participants will have daily study visits (either in person or remote) during the initial buprenorphine induction week and then twice per week during the maintenance phase (either in person or remote) over the 12-week trial. Remote visits will be conducted using the HIPAA-compliant technology, FaceTime and/or Webex.

Вмешательства

• Препарат Buprenorphine SL
  Up to 24 mg per day
• Другое Telehealth
  Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session
• Другое In-person treatment as usual
  in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.

Первичные конечные точки

• Time to drop out [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• meet DSM-5 criteria for OUD
• Voluntarily seeking buprenorphine treatment for OUD
• Able to provide informed consent and comply with study procedures

Критерии исключения

• Meeting DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis that would compromise safety of participation in the trial as determined by the study physician, such as an alcohol or sedative hypnotic use disorder that requires detoxification
• Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as a psychotic disorder including schizophrenia or schizoaffective disorder
• Concurrent methadone, buprenorphine, or vivitrol maintenance treatment
• Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
• Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients
• Unstable medical conditions, such as severe hepatic, renal, or cardiovascular disease, which might make participation
• Current or recent history history of significant violent or suicidal behavior or risk for suicide or homicide
• Legally mandated to substance use disorder treatment.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05339256 · 8305 · R21DA055835

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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