Pain Self-Management and Patient-Oriented Dosing for Pain and Retention in Office-based Addiction Treatment: a Randomized Trial
概览
- 阶段
- 4 期
- 干预措施
- Usual Care
- 疾病 / 适应症
- Opioid Use Disorder
- 发起方
- Erin Winstanley
- 入组人数
- 268
- 试验地点
- 26
- 主要终点
- Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv).
The research study is testing two different interventions along with usual clinical care:
- Pain Self-Management (PSM): an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain.
- Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels.
The interventions will take place over a period of 12 weeks (3 months). Additionally, participants will complete surveys every 3 months for a period of 1 year (total of 5 survey visits). Participants will receive $50 compensation for each survey visit completed (up to $250 over one year) and can receive up to an additional $100 bonus compensation.
There are risks associated with participating in the study, including breach of confidentiality, psychological distress caused by discussing difficult topics, and risks associated with the POD intervention.
研究者
Erin Winstanley
Professor
University of Pittsburgh
入排标准
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Adults at least 18 years old
- •Patient at a participating clinic
- •Ability to speak, read, and understand English
- •Capable of providing informed consent
- •Access to phone and/or internet
- •Documented diagnosis of Opioid Use Disorder (OUD)
- •On a stable dose of an oral or sublingual buprenorphine mono or combination product (\<4 times per day, daily dosage \<32 mg) for at least 7 days during incident new episode of care
- •Have high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Under 18 years of age
- •Have cancer-related pain
- •Are currently in jail, prison, or overnight facility as required by court of law or have pending legal action that could prevent participation in study activities
- •Currently prescribed 32mg of an oral or sublingual buprenorphine mono or combination product
- •Currently prescribed an injectable formulation of buprenorphine
- •Pregnancy or intention to become pregnant within 4 months of enrollment
- •Currently prescribed naltrexone or received naltrexone (Vivitrol) injection in the past 60 days
- •History of hypersensitivity to buprenorphine that a clinician-determined caused serious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylactic shock
- •Currently prescribed/taking methadone or have taken methadone in the past 30 days
研究组 & 干预措施
Usual Care + Standard Buprenorphine Dosing
Usual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions. Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
干预措施: Usual Care
Usual Care + Standard Buprenorphine Dosing
Usual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions. Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
干预措施: Standard Buprenorphine Dosing Condition
Usual Care + Patient-Oriented Dosing (POD)
Usual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions. Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone for treating participants with both opioid use disorder (OUD) and chronic pain. POD allows titration of buprenorphine or buprenorphine/naloxone dosing up to 32mg/day, split into four doses per day, based on the participant's pain level.
干预措施: Patient-Oriented Dosing (POD)
Usual Care + Patient-Oriented Dosing (POD)
Usual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions. Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone for treating participants with both opioid use disorder (OUD) and chronic pain. POD allows titration of buprenorphine or buprenorphine/naloxone dosing up to 32mg/day, split into four doses per day, based on the participant's pain level.
干预措施: Usual Care
Pain Self-Management (PSM) + Standard Buprenorphine Dosing
Pain self-management (PSM) is a manualized behavioral intervention tailored for patients in outpatient-based addiction treatment (OBAT) programs. PSM consists of 12 intervention sessions, comprising 6 group sessions and 6 individual sessions. Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
干预措施: Pain Self-Management (PSM)
Pain Self-Management (PSM) + Standard Buprenorphine Dosing
Pain self-management (PSM) is a manualized behavioral intervention tailored for patients in outpatient-based addiction treatment (OBAT) programs. PSM consists of 12 intervention sessions, comprising 6 group sessions and 6 individual sessions. Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
干预措施: Standard Buprenorphine Dosing Condition
Pain Self-Management (PSM) + Patient-Oriented Dosing (POD)
Pain self-management (PSM) is a manualized behavioral intervention tailored for patients in outpatient-based addiction treatment (OBAT) programs. PSM consists of 12 intervention sessions, comprising 6 group sessions and 6 individual sessions. Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone for treating participants with both opioid use disorder (OUD) and chronic pain. POD allows titration of buprenorphine or buprenorphine/naloxone dosing up to 32mg/day, split into four doses per day, based on the participant's pain level.
干预措施: Patient-Oriented Dosing (POD)
Pain Self-Management (PSM) + Patient-Oriented Dosing (POD)
Pain self-management (PSM) is a manualized behavioral intervention tailored for patients in outpatient-based addiction treatment (OBAT) programs. PSM consists of 12 intervention sessions, comprising 6 group sessions and 6 individual sessions. Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone for treating participants with both opioid use disorder (OUD) and chronic pain. POD allows titration of buprenorphine or buprenorphine/naloxone dosing up to 32mg/day, split into four doses per day, based on the participant's pain level.
干预措施: Pain Self-Management (PSM)
结局指标
主要结局
Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline
时间窗: Baseline, 3 Months
The PROMIS Pain Interference - Short Form 4a is a validated, self-report 4-item tool assessing pain interference over the past 7 days. The PROMIS SF v1.0 - Pain Interference 4a consists of 4 questions and uses a 5-point scale, ranging from 1 (not at all) to 5 (very much). The total raw score equals the sum the values of the response to each question. The raw score is converted to a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. That is, a person has more problems with pain hindering activities. By comparison, a pain interference T-score of 40 is one SD better than average. Change = 3 month score - baseline score
次要结局
- Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline(Baseline, 3 Months)
- Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline(Baseline, 3 Months)
- Proportion of Participants Retained in buprenorphine Treatment at 3 months Post-baseline(3 Months)
- Proportion of Participants Taking any MOUD at 3-, 6-, 9- and 12-months Post-baseline(3 Months, 6 Months, 9 Months, 12 Months)
- Change from Baseline in Self-efficacy as Assessed by the PROMIS Self-Efficacy for Managing Symptoms SF-4a at 3 months Post-baseline(Baseline, 3 Months)
- Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline(3 Months)
- Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline(3 Months)