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Идёт набор NCT06440577

Craving & Decision-Making

Без фазы С лечением Decision Making

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: Audio-visual stimuli (Neutral-Relaxing), Audio-visual stimuli (Drug), Audio-visual stimuli (Non-Food), Audio-visual stimuli (Food).
Кому может быть актуально
Состояния в реестре: Decision Making. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Decision Neuroscience of Craving

Обзор

Craving is the strong desire for something, such as for substances in drug addiction and food or other activities in everyday life. Recent work suggests craving can influence how people make decisions and assign value to choice options available to them, yet the neural mechanisms underlying these interactions between craving and valuation remain unknown. To address this, this study uses cognitive decision-making tasks that measure how much individuals will pay (from a study endowment) to have everyday consumer items or snack foods when they crave something specific (opioids or a specific snack, respectively). First, the study will identify the neural mechanisms for how drug craving (craving for opioids) interacts with valuation for consumer items that have associations with drug use or not in people receiving treatment for opioid use disorder (OUD). This will be evaluated in the activity patterns and interactions among brain regions involved in craving and value assignment during decision-making. Then, the study will examine for parallel mechanisms for how food craving (craving for a specific snack) interacts with valuation for snack food items that have similar features to the craved snack or not in people receiving treatment for OUD and non-psychiatric community control participants.

Вмешательства

  • Поведенческое Audio-visual stimuli (Neutral-Relaxing)
    Audio instruction for participant to allow themselves to experience their feelings followed by 3-min passive viewing of images of neutral everyday objects (e.g., tools, dirt) and their use (construction, gardening).
  • Поведенческое Audio-visual stimuli (Drug)
    Audio instruction for participant to allow themselves to experience their feelings followed by 3-min passive viewing of images of drug paraphernalia (e.g., syringe, tourniquet, heroin) and preparation.
  • Поведенческое Audio-visual stimuli (Non-Food)
    Audio instruction for participant to focus their attention on the experimenter followed by 3-min audio-guided viewing of the experimenter opening/unwrapping an everyday object (e.g., box of crayons) and taking out its contents.
  • Поведенческое Audio-visual stimuli (Food)
    Audio instruction for participant to focus their attention on the experimenter followed by 3-min audio-guided viewing of the experimenter opening/unwrapping a snack (e.g., chocolate bar, bag of chips) and taking out its contents.

Первичные конечные точки

  • Willingness-to-pay [Срок оценки: during the task]
  • fMRI-BOLD activity measured during willingness-to-pay decisions [Срок оценки: during the task]

Критерии участия

Критерии включения

  • At least 18 years of age
  • Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures
  • Minimum of 6th grade reading level

Additional inclusion criteria for participants with OUD:

  • Primary diagnosis of OUD encompassing heroin and/or painkiller use
  • Receiving medications for OUD treatment on an outpatient basis
  • At least 12-month history of opioid use

Критерии исключения

  • Unable to speak or read English
  • Active psychosis or mania
  • Current or past schizophrenia diagnosis
  • History of intellectual disability or developmental or neurological disorder, seizures or epilepsy, or loss consciousness lasting more than 30 minutes
  • Severe medical conditions requiring hospitalization or that, in the opinion of the study staff could compromise study participation
  • MRI contraindications (claustrophobia, nonremovable piercings, certain metal in the body etc.) or pregnancy

Additional exclusion criteria for community control participants:

  • Positive urine drug screen
  • Current or past problematic substance use other than nicotine, and alcohol abuse confined to college or military service
  • Current or past bipolar disorder diagnosis
  • Use of central nervous system medications within the past 6 weeks (e.g., antidepressants, Ritalin)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Rutgers, The State University of New Jersey — Piscataway

Идентификаторы

NCT: NCT06440577 · Pro2018002176 · R01DA054201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗