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临床试验/NCT07086014
NCT07086014招募中不适用

Cue Reactivity Modulation in MSM With Methamphetamine Use Disorder

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年8月19日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
88
试验地点
1
主要终点
Change in EEG-derived late positive potential (LPP) Amplitude

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Change in EEG-derived late positive potential (LPP) Amplitude

时间窗: at approx. 2 weeks and 3 months abstinence

Change in amplitude (or incubation of) the EEG-derived late positive potential (LPP) - an objective neurophysiological marker of drug cue-reactivity - occurs 400 msec after the onset of a drug-related cue. The LPP amplitude has also shown to predict self-reported craving, simulated drug-seeking behavior and relapse, highlighting the clinical utility of this objective metric of cue-reactivity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Parvaz

Associate Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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