Cocaine Cue-reactivity Incubation Study

Официальное название

Cognitive Reappraisal for Mitigating Incubation of Cocaine Cue-Reactivity

Обзор

In this study, the research team proposes to longitudinally assess incubation of cue-reactivity, its reduction with cognitive reappraisal (CR; a self-regulation technique) and examine the impact of CR on clinical outcomes in individuals with cocaine use disorder (CUD). The primary objective is to use psychophysiological markers for tracking brain activity and behavior and changes therein with the use of CR during abstinence in CUD. The secondary objective is to examine whether brain and behavioral changes are associated with clinical outcomes in individuals with CUD. The primary endpoint is the time-related change in brain and behavioral indices with CR during abstinence in individuals with CUD. The secondary endpoint is the impact of CR-mediated changes on clinical outcomes of individuals with CUD. In this 5-yearlong study the research team will recruit 252 individuals seeking-treatment for CUD, 126 of whom will be randomly assigned to complete the Cognitive Reappraisal task repeatedly at 2 weeks, 1-2 months, 3 months, and 5 months after abstinence initiation (CR+ group), and the other 126 will be assigned to complete a Control task at the same time points (CR- group). All individuals between the ages of 18 and 65 years, irrespective of sex and sexual orientation will be recruited. Participation in the research study will be 5 sessions taking place (one at 2 weeks from screening, one at a month from screening, one at 3 months from screening, one at 5 months from screening, and one the month after the 5 month session) over the course of 6 months. The study will include EEG testing and will be administered multiple times over the course of 6 months. Participants will be randomized to one of the two groups; one group will get the Cognitive Reappraisal (CR+) intervention and the other group will get a Control intervention (CR-).

Вмешательства

• Поведенческое Cognitive Reappraisal
  Cognitive Reappraisal (CR) is a cognitive-behavioral technique and will complete the Cognitive Reappraisal task.
• Поведенческое Control cue-reactivity task
  Participants will complete a control cue-reactivity task.

Первичные конечные точки

• Change in Late Positive Potential (LPP) amplitude [Срок оценки: <2 months, 3 months, and 5 months after abstinence initiation]

Вторичные конечные точки (2)

• Change in Late Positive Potential (LPP) amplitude with CR [Срок оценки: <2 months, 3 months, and 5 months after abstinence initiation]
• Changes in cocaine abstinence duration [Срок оценки: <2 months, 3 months, and 5 months after abstinence initiation]

Критерии участия

Критерии включения

• Ability to understand and give informed consent
• Age 18-65
• DSM-5 Diagnosis of CUD (Cocaine Use Disorder)
• Have appropriate abstinence duration (i.e., <2 months) at the first visit.
• Must be seeking treatment for CUD (at the first visit)

Критерии исключения

• DSM-5 diagnosis for other psychiatric illnesses (other than mood and anxiety disorders that are highly comorbid with substance use disorders)
• Urine positive for any psychoactive drugs (e.g., cocaine, methamphetamine, cannabis, opiates, benzodiazepines, etc.) at baseline
• Head trauma with loss of consciousness
• History of neurological diseases, including seizures
• Thick and/or non-removable hair braids that present difficulty for EEG electrode-scalp contact

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

Фундаментальное исследование

Центры проведения

США · 1 центр

• Icahn School of Medicine at Mount Sinai — New York

Идентификаторы

NCT: NCT07091877 · STUDY-22-01618 · R01DA058039

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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