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Идёт набор NCT05829655

Measuring Acute Drug Demand in Humans

Ранняя фаза I С лечением Opioid Use Disorder Opioid Dependence

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: Drug A (Blinded Drug), Drug B (Blinded Drug), Drug C (Blinded Drug), Drug D (Blinded Drug).
Кому может быть актуально
Состояния в реестре: Opioid Use Disorder, Opioid Dependence. 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
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Обзор

This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.

Подробное описание

This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs. Suvorexant is not approved as a treatment to reduce drug use but is approved by the Food and Drug Administration (FDA) to treat insomnia (trouble falling asleep or staying asleep). This study consists of a screening visit and an approximate 14 to 16 day inpatient (overnight) stay at the University of Maryland, Baltimore. Participants will be stabilized on hydromorphone, randomly assigned to receive either suvorexant or placebo, and complete 5 experimental sessions that include taking blinded study medications.

Вмешательства

  • Препарат Drug A (Blinded Drug)
    Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
  • Препарат Drug B (Blinded Drug)
    Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
  • Препарат Drug C (Blinded Drug)
    Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
  • Препарат Drug D (Blinded Drug)
    Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
  • Препарат Suvorexant (20mg/day)
    Double blind administration of suvorexant once per day during residential stay until discharge.
  • Препарат Placebo
    Double blind administration of placebo once per day during residential stay until discharge.

Первичные конечные точки

  • Demand Intensity [Срок оценки: Upon completion of experimental session (~8 hours post drug administration)]
  • Demand Elasticity [Срок оценки: Upon completion of experimental session (~8 hours post drug administration)]
  • Cross-Price Elasticity [Срок оценки: After Experimental Session 4]
Вторичные конечные точки (1)
  • Total Mean Sleep Time [Срок оценки: Through study completion, up to two weeks]

Критерии участия

Критерии включения

  • Age between 18 and 65 years old
  • Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe)
  • Lifetime substance use history criterion \[blinded\]
  • Medically cleared to take suvorexant and blinded study medications
  • Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests

Критерии исключения

  • Pregnant or breast feeding
  • Seeking opioid use treatment
  • Significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff
  • Known contraindications or allergies to suvorexant and/or the blinded study medications

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • General Clinical Research Center — Baltimore

Идентификаторы

NCT: NCT05829655 · HP-00116510 · R01DA055634

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗