Cognitive Functioning in Opioid Use Disorder: Examining the Impacts of Computerized Working Memory Training and Non-Fatal Opioid Overdose
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- NIH Toolbox Cognition Battery
研究概览
简要总结
This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose and cognitive functioning. This study will also examine the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life, drug use). The training component of the study lasts 1 month, with follow up visits and 1-month and 3-months post training.
详细描述
This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose (i.e. overdose that does not result in death), cognitive functioning, and the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life). Participants (n=30) with a history of at least one prior opioid OD, who are enrolled in buprenorphine treatment, will be randomized to 20 sessions of an active (n=15) or sham (n=15) working memory training. Patients will complete measures of cognitive functioning during screening, post-training, and at 1-month and 3-month follow up. Participants will also complete the measures of decision making, psychosocial functioning and drug use at baseline, post-training, and follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants and research staff will be blinded to participant's training condition (active vs. sham)
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
- •Meets DSM-5 criteria for moderate-severe Opioid Use Disorder (OUD) in the past 6 months
- •Enrolled in a suboxone (buprenorphine/naloxone) program; willing to provide consent for research team to contact treatment provider
- •History of at least 1 prior opioid overdose
- •Recent history of illicit opioid use
- •In good physical health
- •Access to a smartphone, tablet, or computer
排除标准
- •Evidence of a co-occurring, untreated psychiatric condition that would make participation risky or difficulty
- •Lack of access to a home computer, smartphone, or tablet
- •Unable to speak, read and/or communicate in English
研究组 & 干预措施
Active
Working memory training with task-difficulty increasing across sessions
干预措施: CogMed (Other)
Sham
Working memory training with task-difficulty remaining constant across sessions.
干预措施: CogMed (Other)
结局指标
主要结局
NIH Toolbox Cognition Battery
时间窗: 3-month Follow up
A brief computerized test of key neuropsychological functions
NIH Toolbox Cognition Battery
时间窗: Post-Training (1-month from baseline)
A brief computerized test of key neuropsychological functions
NIH Toolbox Cognition Battery
时间窗: 1-month Follow up
A brief computerized test of key neuropsychological functions
次要结局
- Illicit Substance Use: Timeline Follow Back (TLFB)(3-month follow up)
- Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)(3-month follow up)
- Quality of Life Scale (QOLS)(3-month follow up)
- Impulsive decision making (Delay Discounting Task)(3-month follow up)
- Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)(Post-training (1 month from baseline))
- Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)(1-month follow up)
- Illicit Substance Use: Timeline Follow Back (TLFB)(Post-training (1-month from baseline))
- Illicit Substance Use: Timeline Follow Back (TLFB)(1-month follow up)
- Quality of Life Scale (QOLS)(Post-training (1 month from baseline))
- Quality of Life Scale (QOLS)(1-month follow up)
- Impulsive decision making (Delay Discounting Task)(Post-training (1 month from baseline))
- Impulsive decision making (Delay Discounting Task)(1-month follow up)
研究者
Sandra D. Comer
Professor of Neurobiology
New York State Psychiatric Institute