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临床试验/NCT03226132
NCT03226132已完成不适用

Biobehavioral Mechanisms Underlying Improving Sleep to Reduce Risk for Substance Use Disorder

Florida State University2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2017年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
2
主要终点
Substance Use Motives (Marijuana Motives Measure)

研究概览

简要总结

Substance use disorders (SUDs) are a prevalent and impairing condition, particularly among trauma exposed individuals. The current proposal aims to address the critical need for targeted direct SUD prevention in this population by intervening on a novel, malleable risk factor for SUD common among trauma-exposed individuals: sleep disturbance. Sleep disturbance prospectively predicts the development of SUD and may confer risk for SUD by increasing stress reactivity, decreasing decision-making abilities, and ultimately promoting substance use to relieve negative affect, a core etiological factor in SUD. However, to our knowledge, no experimental studies have determined whether improving sleep leads to reductions in SUD risk. As such, the current study will use a randomized controlled trial design to test the effects of brief behavioral treatment for insomnia (BBTI) against a waitlist control among a sample of trauma-exposed young adults with poor sleep and risk for SUD (N = 60). We aim to determine the direct and indirect effects of condition (BBTI vs. waitlist control) on SUD symptoms, substance use-related problems, coping motives, and posttraumatic stress symptoms through improvements in sleep. Furthermore, we will test direct and indirect effects of condition on theoretically proposed mechanisms underlying the association between sleep disturbance and SUD risk (i.e., stress reactivity, cravings in response to stress).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Trauma exposure
  • Current cannabis use
  • Insomnia symptoms
  • Age 18-30

排除标准

  • Severe substance use disorder
  • Receiving treatment related to sleep or substance use

结局指标

主要结局

Substance Use Motives (Marijuana Motives Measure)

时间窗: Change from Baseline to Three Months Follow-Up

Insomnia Severity Index (ISI)

时间窗: Change from Baseline to Three Months Follow-Up

PTSD Symptoms (PTSD Checklist-5)

时间窗: Change from Baseline to Three Months Follow-Up

Substance Use Frequency (Timeline Followback)

时间窗: Change from Baseline to Three Months Follow-Up

Substance Use Disorder Symptoms (Cannabis Use Disorder Identification Test; Structured Clinical Interview for Diagnostic and Statistical Manual [DSM]-5)

时间窗: Change from Baseline to Three Months Follow-Up

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

Norman Schmidt

Professor

Florida State University

研究点 (2)

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