Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months
研究概览
简要总结
The purpose of this research study is to look at the effect of programs aimed at helping people manage chronic pain and medication treatment. The program sessions focus on educational information and strategies for pain and medication management. The researchers enroll people who have chronic pain and have recently begun buprenorphine treatment to see if participants could benefit from these programs. This research study will help the researchers learn how to improve current therapies for pain and medication management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having a diagnosis of an opioid use disorders (OUD) within the past 12 months;
- •started buprenorphine (the term we use to refer to all buprenorphine products including buprenorphine/naloxone) treatment within the past 6 months
- •at least moderate or greater self-reported pain on average over the past 3 months;
- •regular and consistent access to a telephone and willingness to use the phone for study sessions.
排除标准
- •buprenorphine medication prescribed in the form of a monthly injection and/or a transdermal patch
- •self-reported pregnancy at the time of study enrollment
- •currently living outside of the United States
结局指标
主要结局
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months
时间窗: 3-months post enrollment
In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 3 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 3-month follow-up.
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months
时间窗: 3-months post enrollment
In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 3 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 3-month follow-up.
次要结局
- Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months(12-months post enrollment)
- Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 3-month Follow up (Compared to Baseline)(3-months post enrollment)
- Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 3-month Follow up (Compared to Baseline)(3-months post enrollment)
- Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months(3-months post enrollment)
- Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 12-month Follow up (Compared to Baseline)(12-months post enrollment)
- Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 12-month Follow up (Compared to Baseline)(12-months post enrollment)
- Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months(12-months post enrollment)
- Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months(3-months post enrollment)
- Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 12-month Follow up (Compared to Baseline)(12-months post enrollment)
- Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 3-month Follow up (Compared to Baseline)(3-months post enrollment)
- Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 3-month Follow up (Compared to Baseline)(3-months post enrollment)
- Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 12-month Follow up (Compared to Baseline)(12-months post enrollment)
- Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months(12-months post enrollment)
研究者
Mark A. Ilgen
Professor of Psychiatry
University of Michigan