Integrative Treatment for Achieving Holistic Recovery From Comorbid Chronic Pain and Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Change in Pain Interference
研究概览
简要总结
This study is a multisite randomized clinical trial of a treatment designed to reduce pain interference while simultaneously addressing relapse prevention among individuals who have co-occurring chronic pain and Opioid Use Disorder (OUD). This study will recruit approximately 160 individuals who are currently being treated in clinics specializing in the physician management of OUD. To increase generalizability of study findings and increase internal validity of the physician management component of treatment, all participants will be stabilized on buprenorphine for OUD as part of their usual clinical care. Individuals will be randomized to either: (1) enhanced usual care or (2) the integrated ACT + MBRP treatment. The investigators hypothesize that: (1) the combination of ACT + MBRP in buprenorphine-prescribed patients with chronic pain will be more efficacious across primary and secondary outcome measures in comparison to Enhanced Usual Care and (2) examination of treatment mechanism data will indicate treatment-related changes that are consistent with the theoretical models of ACT+MBRP.
详细描述
Opioid prescription in the treatment of chronic pain is frequent and carries a consequent risk of poor treatment outcome, as well as higher morbidity and mortality in a clinically significant number of patients, particularly those who meet criteria for OUD. Despite the alarming increases in opioid misuse and OUD nationally, there are few treatment options available that target both pain-related interference and OUD in an integrated fashion among patients with chronic pain. To date, there are no evidence-based treatment options that aim to minimize pain interference while simultaneously addressing OUD among individuals with medication prescribed for OUD.
The present trial builds upon a pilot study that tested the feasibility of integrating two empirically-supported psychosocial interventions, ACT to reduce pain interference and MBRP to reduce opioid misuse. Following successful integration of the interventions, outcome analyses found that the integrated ACT + MBRP intervention reduced both pain interference and opioid misuse at a 6-month follow-up in comparison to physician management alone.
This study is a multisite randomized clinical trial that will recruit approximately 160 individuals who are currently being treated in clinics specializing in the physician management of OUD. To increase generalizability of study findings and increase internal validity of the physician management component of treatment, all participants will be stabilized on buprenorphine for OUD as part of their usual clinical care. Individuals will be randomized to either: (1) enhanced usual care or (2) the integrated ACT + MBRP treatment.
The primary outcome, pain interference, will be assessed at the end of the active treatment phase and at 6- and 12-month follow-ups. Secondary outcomes will include pain intensity, depression, and pain-related fear, and an exploratory outcome of self-report of substance use with urine testing for confirmation. Treatment mechanism variables, including chronic pain acceptance, engagement in values-based action, and opioid craving will be assessed weekly during the active phase of treatment.
Our overall hypotheses are that: (1) the combination of ACT + MBRP in buprenorphine-prescribed patients with chronic pain will be more efficacious across primary and secondary outcome measures in comparison to EUC and (2) examination of treatment mechanism data will indicate treatment-related changes that are consistent with the theoretical models of ACT+MBRP.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
All investigators (Drs. Pearson, Witkiewitz, Hurlocker, Ilgen, and Lin) will be blinded. The research coordinators located within each site will not be blinded, as they will be involved in coordinating participant screening and randomization. Data analysis will be conducted by a study statistician blinded to participant condition.
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
- •Stabilized on a dose of buprenorphine for a period of at least 1 month. Buprenorphine stabilization will be defined as a consistent dose for at least 30 consecutive days.
- •Willing to comply with all study procedures and be available for the duration of the study.
- •Aged 18 years or older.
- •Enrolled as a patient in one of the participating clinics.
- •Presence of chronic pain for > 6 months in duration.
排除标准
- •Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders.
- •Unable to read English.
- •Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
结局指标
主要结局
Change in Pain Interference
时间窗: Change from baseline through 12-month follow-up period
Pain interference between participants randomized to ACT+MBRP vs EUC assessed by Pain interference will be measured via Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference: The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference. Each item ranges from 0 (not at all) to 5 (very much interfered) and higher scores reflect more severe pain interference. This questionnaire asks about pain interference in the past 7 days (collected once at baseline, post-treatment, and months 6 and 12).
次要结局
- Change in Craving(Change from baseline through 12-week treatment period and 12-month follow-up period)
- Change in Depression(Change from baseline through 12-month follow-up period)
- Change in Pain Intensity(Change from baseline through 12-month follow-up period)
- Change in Pain Acceptance(Change from baseline through 12-week treatment period and 12-month follow-up period)
- Change in Valued-Action(Change from baseline through 12-week treatment period and 12-month follow-up period)
- Change in Pain-Related Anxiety(Change from baseline through 12-month follow-up period)
研究者
Katie A Witkiewitz
Grant Principal Investigator
University of New Mexico