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Набор скоро начнётся NCT07306078

Methylphenidate and Response to Alcohol Cues

Фаза II С лечением Alcohol 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: Methylphenidate Pill, Placebo Pill.
Кому может быть актуально
Состояния в реестре: Alcohol Use Disorder. Базовые параметры: 18 лет — 25 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

Attentional Ability and Resilience to Alcohol Use Disorder: Neurocognitive Mechanisms: Protocol Two

Обзор

The purpose of this study is to determine whether changes in attention levels related to taking a single dose of a medication called methylphenidate, also known as Ritalin, affects responses to alcohol cues. The study will observe the effects of methylphenidate or a placebo on neural and craving responses to alcohol cues through fMRI and behavioral testing. Participants will be involved in one remote and two in-person sessions.

Подробное описание

Recent studies have revealed a robust link between attentional ability and resilience against stress-related psychopathology, in general, and against alcohol use disorder (AUD) specifically. For example, self-reported attentional ability correlates with scales of psychological resilience and with lower alcohol misuse in at-risk individuals. One mechanism by which attention may relate to resilience in AUD is through its effects on alcohol cue reactivity. Exposure to alcohol cues can induce motivation to drink alcohol for those with AUD. Leveraging the high rates of co-morbidity of AUD and attention-deficit/hyperactivity disorder, this pilot study seeks to demonstrate whether experimentally enhancing attention in individuals with alcohol misuse reduces markers of addiction severity (i.e., craving and attentional bias responses to alcohol cues) and will explore the neural and behavioral mechanisms. Methylphenidate not only improves sustained attention, but in users of cocaine and methamphetamine, it was previously shown to reduce craving, attentional bias, and neural responses to viewing drug-related cues. This study will use this commonly-prescribed medication as a pharmacological probe of attentional processes related to alcohol use disorder. It is hypothesized that acute methylphenidate-associated attentional enhancement will engage compensatory brain mechanisms that will lead to attenuated craving, reduced attentional bias, and modulated neural responses to alcohol cues in young adults. Fifty young adults reporting hazardous alcohol use will be recruited for a double-blind, placebo-controlled, within-subjects experiment to test the effects of an acute 20 mg methylphenidate administration to increase attention on cue-induced alcohol craving \[during functional magnetic resonance imaging (fMRI)\] and attentional bias. Subjects will also perform computerized tasks of general attention with non-alcohol-related stimuli.

Вмешательства

  • Препарат Methylphenidate Pill
    Encapsulated methylphenidate
  • Другое Placebo Pill
    Encapsulated placebo

Первичные конечные точки

  • Neural responses to cues [Срок оценки: 15 minutes]
Вторичные конечные точки (1)
  • Self-reported craving [Срок оценки: 15 minutes]

Критерии участия

Критерии включения

  • Adults ages 18-25 years
  • Meets DSM-5 criteria for Alcohol Use Disorder -OR- score on the Alcohol Use Disorders Identification Test (AUDIT) of >=8
  • Fluent in English
  • Normal or corrected to normal vision

Критерии исключения

  • Meets DSM-5 criteria for psychotic disorders, neurological disorders, or substance use disorders other than Alcohol Use Disorder.
  • Participant routinely uses psychoactive drugs or medications except for non-dependent marijuana or nicotine use (due to common use of these substances in individuals with Alcohol Use Disorder).
  • Participant has contraindications for taking methylphenidate.
  • Participant has contraindications for being in an MRI machine
  • Self-reported history of high blood pressure over 140/90 or consistent readings of 140/90 or above upon arrival for a session.
  • History of seizure disorder
  • Liver disease
  • Participant is currently pregnant or trying to become pregnant

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Florida — Gainesville

Идентификаторы

NCT: NCT07306078 · IRB202500591 · R01AA032400

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗