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Идёт набор NCT07086014

Methamphetamine Cue-reactivity

— Наблюдательное Methamphetamine 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: Cognitive Reappraisal.
Кому может быть актуально
Состояния в реестре: Methamphetamine Use Disorder. Базовые параметры: 18 лет — 60 лет · Мужчины.
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

Cue Reactivity Modulation in MSM With Methamphetamine Use Disorder

Обзор

In this observational cohort study, the researchers propose to first identify a psychophysiological marker of methamphetamine cue-reactivity and its incubation with abstinence from methamphetamine use (MUD) and examine group-differences between men who have sex with men (MSM) and non-MSM MUD. The primary objective is to identify psychophysiological markers of methamphetamine (MA) cue-reactivity and its abstinence incubation. The secondary objective is to examine group-differences in methamphetamine use disorder (MUD) individuals between homosexual men (MSM) and heterosexual men (non-MSM). The primary endpoint is to assess incubation of cue-reactivity longitudinally with its reduction in cognitive reappraisal, and the secondary endpoint is to examine the impact of cognitive reappraisal on clinical outcomes of methamphetamine use disorder (MUD) in homosexual men (MSM). 2-year long study. Screening and enrollment will be done at different locations of the Addiction Institute of Mount Sinai. The EEG session will be done at Icahn School of Medicine at Mount Sinai. Participation in the research study will be for a single EEG session.

Подробное описание

Cognitive Reappraisal (CR) is an extensively characterized emotion-regulation strategy that impacts early cognitive stages of emotion-generative processes and can be used to regulate emotional experience and expression. CR techniques include "distancing" that aims at changing the emotional impact of a situation by taking the perspective of a detached observer, and "reinterpretation" that focuses on re-evaluating the emotional situation in unemotional terms. Neuroimaging studies of CR implicate the engagement of regions that have typically been associated with conflict monitoring, selective attention, and regulation of negative affect. A growing literature indicates that CR can attenuate heightened cue-reactivity in addicted individuals. The researchers preliminary data in CUD are consonant with this view and show that decrease in cue-reactivity can be quantified by a reduction in the LPP (Parvaz et al., PNAS, 2021). The researchers have also shown that more frequent use of CR is correlated with reduced cue-reactivity and lower craving in CUD. Others have reported that CR can modulate attention bias to affective stimuli with sustained decrease even after regulation demands are lifted. Clinical studies show that CR training is associated with better cognitive control, and better clinical outcomes in smokers. Thus, CR has the potential to decrease MA cue-reactivity and may lead to better clinical outcomes in MSM with MUD.

Вмешательства

  • Поведенческое Cognitive Reappraisal
    an emotion-regulation strategy while being asked to complete cognitive tasks.

Первичные конечные точки

  • Change in EEG-derived late positive potential (LPP) Amplitude [Срок оценки: at approx. 2 weeks and 3 months abstinence]

Критерии участия

Критерии включения

  • Ability to understand and give informed consent
  • Identify as either MSM or non-MSM
  • Males; Age 18-60
  • DSM-5 Diagnosis of MUD (Methamphetamine Use Disorder)
  • Have appropriate abstinence duration \[i.e., current Methamphetamine users (MA): 2 weeks (range: 1-3 weeks); MA-abstinent: 3 months (range: 2-4 months)\]
  • Treatment-seeking MUD must be in a treatment facility for substance use disorder, with MA as the primary drug (at the first visit)
  • Treatment-seeking MUD must be abstinent from MA use for approximately 2 weeks (range: 1-3 weeks) at enrollment.

Критерии исключения

  • Women

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Icahn School of Medicine at Mount Sinai — New York

Идентификаторы

NCT: NCT07086014 · STUDY-20-00284 · R61DA056779

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗