Culturally Adapted Contingency Management
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: Cultually Adapted Contingency Management (CM), Basic Contingency Management (CM).
- Кому может быть актуально
- Состояния в реестре: Stimulant Use Disorders. 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
Cultural Adaptation of Contingency Management for Black Adults With Stimulant Use Disorder
Обзор
The purpose of this study is to develop a culturally adapted contingency management (CM) protocol for Black adults with stimulant use disorder.
Подробное описание
This project seeks to develop a culturally adapted Contingency Management (CM) intervention for Black adults with stimulant use disorder (StUD). CM is grounded in behavioral economics and involves the use of tangible positive reinforcements to incentivize verifiable pro-health behaviors. There has been a recent surge in fatal stimulant related drug overdoses in the Black community. Black adults in the United States have been experiencing faster rates of overdose deaths, with a rate of 49.5/100,000 in 2022 (1.4 times the rate among White Americans). A resurgence in stimulant use, contamination of community drug supplies with high potency synthetic opioids (HPSO) and a range of structural and social vulnerabilities are major drivers of this unfortunate trend. CM has been shown to be the most effective intervention for StUD as there are no FDA approved medications for this indication. Emerging evidence shows that Black adults who entered treatment with cocaine-positive urines did not show any gains in treatment retention or other clinical outcomes. This observation of disparate health outcomes has informed the urgency to culturally adapt CM for Black population which is at heightened risk given the opioids/stimulant polysubstance fatal overdose.
The objective of this research is to develop components of a culturally adapted CM using theoretically and empirically driven approaches. Specific research aims include: 1) Assessment of the target population's behavioral risks, perceived need for prevention, barriers, preferences for intervention and development of components of CM adaptation; 2) production of iterative drafts of the adapted CM and 3.) Pilot randomized controlled trial to examine the short-term efficacy of the adapted CM with the primary outcomes of percent negative urines and longest duration of abstinence during treatment. Aim 3 consists of PI training to deliver the culturally adapted treatment and the culturally adapted treatment will be piloted with the community that the treatment was adapted for over 12 weeks, twice weekly, with a 4 week lead-in phase.
Aims 1 and 2 are Observational aims not requiring registration that will inform Aim 3.
The focus of this registration is Aim 3.
Вмешательства
- Поведенческое Cultually Adapted Contingency Management (CM)
Same protocol as basic CM with adaptations incorporated. The adaption will involve the ADAPT-ITT framework and PEN-3 cultural model. - Поведенческое Basic Contingency Management (CM)
An escalating schedule of reinforcement for submitting stimulant-negative urine at each clinic visit over the course of the 12 weeks
Первичные конечные точки
- Percent negative urine samples [Срок оценки: Week 12]
- Mean longest duration of abstinence [Срок оценки: Week 12]
Вторичные конечные точки (4)
- Mean treatment retention [Срок оценки: Baseline and Week 12.]
- Acceptability of Intervention Measure (AIM) [Срок оценки: Week 12]
- Feasibility of Intervention Measure (FIM) [Срок оценки: Week 12]
- Client Satisfaction Questionnaire (CSQ-8) [Срок оценки: Week 12]
Критерии участия
Критерии включения
- participants must self-identify as Black/African American
- DSM-5 diagnosis of stimulant use disorder in the past month (30 days)
Критерии исключения
- individuals who are intoxicated or otherwise unable to provide consent
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
- Connecticut Mental Health Center (CMHC) — New Haven
Публикации
- Jegede OO, Becker SJ, Iheanacho T, Bellamy C, Petrakis I, Kiluk B, Rash C. Rationale, design and methods of the Cul-CM study: a protocol for cultural adaptation of contingency management in adults with stimulant use disorder. BMJ Open. 2026 Jul 8;16(7):e120424. doi: 10.1136/bmjopen-2026-120424. PMID 42419893
Идентификаторы
NCT: NCT07443332 · 2000040284 · 1K23DA063650-01