The Neural Basis of Approach Bias Modification in Opioid Users With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3
研究概览
简要总结
To investigate the neurobiological mechanisms underlying opioid approach bias during a pilot RCT of opioid approach bias modification. The investigators are combining novel ultra-high field MRI technology with the promising treatment of modifying cognitive bias away from detrimental prescription drug use will generate novel neural data and potentially yield a new therapeutic tool to reduce problematic opioid use.
详细描述
The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 6-session (over 2 weeks) clinical trial of opioid approach bias modification (OABM) in 20 male and female veterans with chronic pain at high risk for opioid-related adverse events at the San Francisco Veterans Affairs Health Care System, between ages 18-69. The study consists of screening, 2-week cognitive training, Week-3 post-assessment. Assessment of the neurobiological mechanisms of opioid approach bias will be administered at baseline and Week-3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female veterans eligible for VA services
- •Ages 18-69
- •Chronic pain (current pain lasting ≥ 90 days)
- •Prescribed chronic opioids (≥ 90 days in past year)
- •High risk for opioid-related averse outcomes (≥ 20mg morphine equivalent daily dose).
排除标准
- •Psychotic, bipolar disorders or other psychiatric disorders judged to be unstable by the PI
- •Current or past history of the following: intrinsic cerebral tumors, cerebrovascular accident/disease, brain aneurysm, arteriovenous malformations, surgical implantation of neurostimulators or cardiac pacemakers, demyelinating and neurodegenerative diseases, penetrating traumatic brain injury, and any other MRI contraindications.
- •No female participant will be pregnant or actively attempting to conceive to prevent any unnecessary exposure to high magnetic fields or radio frequency energy to the unborn child.
- •Concurrent participation in a treatment study
- •Moderately Severe/Severe withdrawal from opioids based on a score of 25 or more on the Clinical Opiate Withdrawal Scale (COWS)
研究组 & 干预措施
opioid approach bias training
Immediately following screening, patients will be randomly assigned to receive 6 sessions of opioid approach bias modification taking place over two weeks.
干预措施: opioid approach bias modification (Behavioral)
sham training
Immediately following screening, patients will be randomly assigned to receive 6 sessions of sham training taking place over two weeks.
干预措施: sham training (Behavioral)
结局指标
主要结局
Change in reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3
时间窗: baseline to end of treatment, week 3
millisecond reaction time of (opioid push - opioid pull) - (non-opioid push - opioid pull) on an opioid approach-avoidance task where participants are asked to respond to the format of presented pictures, irregardless of the content. There are two categories of pictures; 20 different opioid pictures and 20 different non-opioid pictures, with two-hundred trials. Millisecond reaction time will be measured at baseline, prior to each training session during the 2-week training period, and at week 3 post training assessment. Primary outcome is change in reaction time across time in active vs. sham condition.
次要结局
未报告次要终点