Cognitive Reappraisal for Mitigating Incubation of Cocaine Cue-Reactivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Change in Late Positive Potential (LPP) amplitude
研究概览
简要总结
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-).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change in Late Positive Potential (LPP) amplitude
时间窗: <2 months, 3 months, and 5 months after abstinence initiation
EEG-derived Late Positive Potential (LPP) amplitude will be measured while participants view cocaine-related cues. Higher amplitudes indicate greater cue reactivity.
次要结局
- Change in Late Positive Potential (LPP) amplitude with CR(<2 months, 3 months, and 5 months after abstinence initiation)
- Changes in cocaine abstinence duration(<2 months, 3 months, and 5 months after abstinence initiation)
研究者
Muhammad Parvaz
Associate Professor
Icahn School of Medicine at Mount Sinai