Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mean Cognitive Change from Baseline to Endpoint
研究概览
简要总结
Research has consistently found that cognitive impairment is common in persons with a history of substance abuse. The most commonly identified impairments across all substances are in attentional and working memory functioning and executive functioning; opioid-specific research finds that memory is an additional area of common impairment. Initial research in applying cognitive rehabilitation methods to substance abuse have shown it to be helpful overall.
To develop a cognitive rehabilitation intervention that is effective for opioid abuse, this study will adapt a cognitive training program that has been shown to be effective in other patient groups. Patients in a residential opioid-abuse treatment program will undergo a cognitive evaluation and then be assigned to receive the 4-week cognitive intervention or the 4-week placebo control arm. It is expected that the intervention group will show greater gains on the cognitive post test and will have higher rated treatment adherence and opioid treatment program completion rates.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has completed the detoxification process
- •Has completed at least 8 years of formal education
- •Speaks and reads English fluently
- •Is beginning residential inpatient treatment for opioid abuse (note: may be receiving treatment for polysubstance abuse but opioid must be one of their regular drugs of abuse)
排除标准
- •Unable to self-consent (has a proxy for medical decision-making, legal guardian, or been otherwise determined unable to give consent)
- •Past diagnosis or suspected current diagnosis of a neurodevelopmental disorder (e.g., autism, learning disability), attention-deficit disorder, or neurocognitive disorder (e.g., dementia)
- •History of major head trauma (defined as loss of consciousness for 30 minutes or longer) or brain surgery. (Note: History of concussion, including brief loss of consciousness, is okay)
结局指标
主要结局
Mean Cognitive Change from Baseline to Endpoint
时间窗: Post-intervention at week 4
Change in overall cognitive summary score from pretest to posttest on NIH Toolbox.
Substance Abuse Program Completion Rate
时间窗: Until treatment program discharge, usually 30-45 days
Completion rate of recommended treatment program length, quantified as percentage completed
次要结局
未报告次要终点