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Идёт набор NCT06726200

A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use

Ранняя фаза I С лечением Opioid Use Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Buprenorphine + naloxone (Suboxone), Buprenorphine Injection.
Кому может быть актуально
Состояния в реестре: Opioid Use Disorder. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized Controlled Trial Examining Extended-Release Injectable Buprenorphine in Those Who Use High Potency Synthetic Opioids

Обзор

The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and/or other high potency synthetic opioids. Individuals aged 18-65 will be eligible for enrollment. The main questions it aims to answer are: Are there differences in frequency of drug use after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Are there differences in rates of sustained relapse after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Investigators also seek to understand and explore: How factors like body fat, body weight, and quantity of fentanyl use before treatment influence treatment outcomes. How blood levels of buprenorphine and its metabolite norbuprenorphine early on in treatment may influence treatment outcomes. How factors like craving and opioid withdrawal symptoms influence treatment outcomes. Participants will: Complete a brief overnight hospital stay in an inpatient research unit. This hospital stay will enable participants to start treatment with either sublingual buprenorphine or injectable buprenorphine. Provide blood and urine samples while on the inpatient unit and at follow up. Complete in-person follow up visits at 1-, 2-, 3- and 4-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.

Вмешательства

  • Препарат Buprenorphine + naloxone (Suboxone)
    Participants randomized to sublingual buprenorphine naloxone will initiate treatment based on clinical guidelines/standard of care
  • Препарат Buprenorphine Injection
    Participants randomized to injectable buprenorphine naloxone will receive a 300mg injection after receiving/tolerating a single 4/1 mg sublingual buprenorphine/naloxone dose

Первичные конечные точки

  • Percentage of Days Abstinent from Opioids [Срок оценки: 4 week follow up period]
  • Sustained Relapse [Срок оценки: 4 week follow up period]
Вторичные конечные точки (3)
  • Time to Peak Clinical Opiate Withdrawal Scale (COWS) score [Срок оценки: During the inpatient induction period (approximately 1 overnight stay)]
  • Peak Clinical Opiate Withdrawal Scale (COWS) score [Срок оценки: During the inpatient induction period (approximately 1 overnight stay)]
  • Dropout during induction [Срок оценки: During the inpatient induction period (approximately 1 overnight stay)]

Критерии участия

Критерии включения

  • Aged 18 to 65
  • Voluntarily seeking treatment for opioid use disorder (OUD)
  • Consistent use of fentanyl or other high potency synthetic opioids
  • Meets DSM-5 criteria for OUD with at least moderate severity
  • Able to provide written informed consent in English and willing to comply with study procedures

Критерии исключения

  • Meets DSM-5 criteria for another substance use disorder as the primary diagnosis
  • Has an active, unmanaged psychiatric condition that would make participation hazardous (e.g., acute, psychosis, current suicidality, current manic episode)
  • Has an active, unmanaged medical condition that would make participation hazardous or preclude use of buprenorphine or ancillary medications for withdrawal (e.g., unmanaged hypertension, unmanaged diabetes, clinically significant abnormality on ECG, acute hepatitis)
  • Buprenorphine or methadone treatment in the past 30 days
  • Known allergy, hypersensitivity or intolerance to buprenorphine
  • Pregnancy, lactation, or unwillingness to use adequate contraceptive methods
  • Current physiological dependence on sedative-hypnotics or alcohol that would require medically supervised detoxification
  • Liver function tests > 2x the upper limit of normal
  • Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days

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
  • Substance Treatment and Research Service — New York

Идентификаторы

NCT: NCT06726200 · AAAV2503 · K23DA057392-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗