Integrating Brain, Neurocognitive, and Computational Tools in OUD

Официальное название

Integrating Brain, Neurocognitive, and Computational Tools in Opioid Use Disorder (OUD) to Characterize Executive Function and to Predict Clinical Outcomes.

Обзор

The 5-year K01 Mentored Research Scientist proposal will employ brain, neurocognitive, and computational tools (e.g., machine learning) to understand the impact of opioid-use disorder (OUD) and common co-occurring issues on executive function and clinical outcomes. There have been record numbers of fatal and non-fatal overdoses (ODs) associated with opioids (and other drugs) in the past 12-months. Improving classification and predictive capabilities to enhance treatment and prevent relapse is of the upmost importance. Deficits in neurocognition often are associated with poor treatment outcomes (e.g., more drug use, medication non-adherence), yet co-occurring issues associated with OUD (e.g., depression, anxiety, physical/sexual abuse, neglect) make it difficult to parse which contributing factors lead to worse executive function (EF) and poorer treatment outcomes. Novel brain, neurocognitive, and computational tools are needed to help determine these differences, in order to lay the foundation for better treatments. This need has shaped both the training plan and the associated research project in a 5-year K01 Mentored Research Scientist proposal, building on Dr. Regier's prior preclinical and clinical addiction neuroscience experience (focused mostly on cocaine-use disorders, cue-reactivity, subcortical networks, prior adversity, and univariate imaging techniques).

Вмешательства

• Диагностический тест Neurocognitive battery
  The Penn Computerized Neurobehavioral Battery (CNB) consists of a series of cognitive tasks, measuring accuracy and speed of performance in major cognitive domains, including executive functions (i.e., abstraction, sustained attention, working memory), episodic memory (i.e., verbal, facial, and spatial memory), complex cognitive processing (i.e., language reasoning, nonverbal reasoning, spatial processing), social cognition (i.e., emotion identification, emotion intensity differentiation, age di
• Диагностический тест fNIRS
  Functional near-infrared spectroscopy (fNIRS) is a noninvasive optical imaging technique that measures changes in oxygenated and deoxygenated hemoglobin (Hb) concentrations within the brain by means of their characteristic absorption spectra of the wavelengths range of 700-1000 nm \[35,36\].

Первичные конечные точки

• Drug use [Срок оценки: weeks 1 through 8]
• Medication adherence [Срок оценки: weeks 1 through 8]
• Mental health symptoms [Срок оценки: weeks 1 through 8]

Критерии участия

Критерии включения

• men and women with moderate to severe opioid use disorder by Diagnostic and Statistical Manual, version 5, (DSM-V) criteria on a stable (at least one week without change) dose of oral buprenorphine-naloxone or methadone. (for OUD group)
• Eligible participants will be between 18-60 years of age;
• able to read at an eighth-grade level;
• able to speak English.

Критерии исключения

• unable to understand or complete the tasks.
• Certain mental health conditions, including (but not limited to) bipolar I with current manic episode, schizophrenia, and schizoaffective disorder, determined by the Principal Investigator (PI) to interfere with study participation.
• moderate or severe substance-use disorder (for Healthy Controls)

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

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT06136247 · 854332

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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