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Идёт набор NCT06718491

Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

Без фазы 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: Managing Physical Reactions to Overwhelming Emotions (IMPROVE), Health Education Training (HET).
Кому может быть актуально
Состояния в реестре: Opioid Use Disorder. Базовые параметры: от 18 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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Официальное название

Brief Digitally-Enhanced Intervention for Managing Emotional Pain and Reducing Alcohol Use During Medication for OUD

Обзор

The goal of this clinical trial is to reduce heavy drinking and enhance medication for opioid use disorder (MOUD) outcomes in individuals receiving MOUD. The main questions it aims to answer are: * Does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called Managing Physical Reactions to Overwhelming Emotions (IMPROVE), impact daily alcohol use and MOUD adherence? * Does the intervention change self-report and physiological responses to intolerance to uncertainty and anxiety sensitivity? Researchers will compare IMPROVE to a control intervention (health education treatment) to see if IMPROVE impacts daily alcohol use and MOUD adherence. Participants will: * Complete a baseline electroencephalography (EEG) and self-report questionnaires. * Complete three one-hour intervention sessions (IMPROVE or control) each one week a part. * Complete a post-intervention EEG and self-report questionnaires. * Complete five ecological momentary assessment (EMA) surveys a day for 21 days. * Complete self-report questionnaires one-month after their last intervention session.

Вмешательства

  • Поведенческое Managing Physical Reactions to Overwhelming Emotions (IMPROVE)
    Participants may be randomized to IMPROVE. IMPROVE is a three session virtual intervention delivered by research clinicians and augmented by a mobile application. The treatment is designed to target and reduce distress contributing to heavy alcohol use during medication for opioid use disorder treatment.
  • Поведенческое Health Education Training (HET)
    Participants may be randomized to HET. HET is an active control intervention that is equally intensive as IMPROVE It includes three virtual sessions and a mobile application. HET is designed to target healthy lifestyle behaviors such as diet and sleep.

Первичные конечные точки

  • Alcohol Use [Срок оценки: Change from baseline to post-treatment (week 4)]
  • Startle eyeblink potentiation during unpredictable threat [Срок оценки: Change from baseline to post-treatment (week 4)]
  • Self-reported Intolerance of Uncertainty [Срок оценки: Change from baseline to post-treatment (week 4)]
  • Late positive potential when viewing anxiety sensitivity evoking images [Срок оценки: Change from baseline to post-treatment (week 4)]
  • Self-reported Anxiety Sensitivity [Срок оценки: Change from baseline to post-treatment (week 4)]
Вторичные конечные точки (3)
  • Medication Adherence [Срок оценки: Change from baseline to post-treatment (week 4)]
  • Distress-related alcohol use [Срок оценки: Assessed multiple times a day for 21 days]
  • Daily alcohol craving [Срок оценки: Assessed multiple times a day for 21 days]

Критерии участия

Критерии включения

  • Enrolled in outpatient medication for opioid use disorder (MOUD) program (within the past month)
  • Heavy alcohol user defined using the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria (i.e., consume 8+/15+ drinks per week \[women/men\] with at least two binge episodes \[4/5+ drinks for women/men in a 2 hour period\] in the past month)
  • Elevated psychological distress defined as a total score of > 12 on the Kessler Psychological Distress Scale (K10; 0 to 40 range)
  • 18 years of age or older
  • Can read and comprehend English

Критерии исключения

  • Do not pass the informed decision-making capacity screener, suggesting cognitive impairment or an inability to provide informed consent
  • Presence of a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g., psychosis, mania, acute intoxication)
  • Current comorbid moderate to severe substance use disorder other than alcohol and opioids
  • Limited or no access to a smart phone that is compatible with the mobile application
  • Participation in Phase One
  • Possibility of being pregnant (by self-report)
  • Current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Ohio State University — Columbus

Идентификаторы

NCT: NCT06718491 · 2024H0358

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗