Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment
- Conditions
- Opioid Use DisorderChronic Pain
- Interventions
- Behavioral: Usual CareDrug: Patient-Oriented Dosing (POD)Behavioral: Pain Self-Management (PSM)
- Registration Number
- NCT06367387
- Lead Sponsor
- Jessica Merlin
- Brief Summary
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:
1. 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.
2. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 460
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 from participating clinics
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Ability to speak, read, and understand English
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Capable of providing informed consent
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Access to phone and/or internet
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Documented diagnosis of Opioid Use Disorder (OUD)
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Within <180 days (6 months) of a new treatment episode, ideally within 90 days (3 months)
- New treatment episode is defined as not having received prescribed buprenorphine treatment in an outpatient setting for OUD in the prior 30 days (1 month)
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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
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Have high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)
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
- History of hypersensitivity to buprenorphine that a clinician-determined caused serious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylactic shock
Individuals with common comorbidities, such as depression, anxiety, or alcohol, methamphetamine, and other substance use disorders will not be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Usual Care + Standard Buprenorphine Dosing Usual Care 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. Usual Care + Patient-Oriented Dosing (POD) 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. Usual Care + Patient-Oriented Dosing (POD) Usual Care 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. Pain Self-Management (PSM) + Patient-Oriented Dosing (POD) 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. Pain Self-Management (PSM) + Patient-Oriented Dosing (POD) Pain Self-Management (PSM) 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. Pain Self-Management (PSM) + Standard Buprenorphine Dosing Pain Self-Management (PSM) 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. Usual Care + Standard Buprenorphine Dosing Standard Buprenorphine Dosing Condition 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. Pain Self-Management (PSM) + Standard Buprenorphine Dosing Standard Buprenorphine Dosing Condition 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.
- Primary Outcome Measures
Name Time Method Proportion of Participants Retained in buprenorphine Treatment at 3 months Post-baseline 3 Months Proportion retained is defined as # completed visits divided by # scheduled visits
Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline 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
- Secondary Outcome Measures
Name Time Method Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline Baseline, 3 Months The Pain, Enjoyment, and General Activity (PEG) Scale is a validated, self-report 3-item tool assessing pain intensity and interference over the past week. The PEG scale consists of 3 separate numerical scales. Each scale has ratings ranging from 0-10. The PEG score is calculated by averaging the three numbers; a higher score indicates greater pain.
Change = 3 month score - baseline scoreChange from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline Baseline, 3 Months The Pain Catastrophizing Scale is a validated, self-report 6-item tool assessing assess pain catastrophizing for chronic pain. The PCS-6 uses a 5-point scale, ranging from 0 (not at all) to 4 (all the time). The total score ranges from 0 to 24, with higher score representing greater catastrophic thinking.
Change = 3 month score - baseline scoreProportion of Participants Taking any MOUD at 3-, 6-, 9- and 12-months Post-baseline 3 Months, 6 Months, 9 Months, 12 Months Measured by self-report and medical chart extraction
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 The PROMIS Self-Efficacy for Managing Symptoms - Short Form 4a is a validated, self-report 4-item tool assessing current level of confidence to managing symptoms in relation to a chronic condition. The PROMIS SF v1.0 - Pain Interference 4a consists of 4 questions and uses a 5-point scale, ranging from 1 (I am not confident at all) to 5 ( I am very confident). 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 example, a T-score of 55 on the PROMIS Self-Efficacy for Managing Emotions indicates that the respondent has greater self-efficacy for managing their emotions than the general chronic condition population (i.e., half a standard deviation higher).
Change = 3 month score - baseline scoreNumber 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 The modified ASI is a validated, self-report tool which includes questions from the Addiction Severity Index section on drug and alcohol use and includes questions about specific opioids used. The number of days in the last 30 that a participant reports using heroin, fentanyl, and/or opioid analgesics (percocet, oxycodone, oxycontin, vicodin, dilaudid, hydrocodone, hydromorphone, morphine, or codeine) will be summed for the outcome "Number of days non-prescribed opioids were used in the past 30 days." Number of days may range from 0 to 90.
Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline 3 Months The IMPOWR Opioid Misuse Screening scale is an exploratory, self-report scale consisting of 4 questions about the use of prescribed pain medications. Each question response ranges from Never (0) to Almost Always (4) with a possible summed score ranging from 0 to 16, with higher scores indicating more severe misuse.
Trial Locations
- Locations (13)
Outpatient Addiction Treatment Services (OATS)
🇺🇸Baltimore, Maryland, United States
Wells House
🇺🇸Hagerstown, Maryland, United States
WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT)
🇺🇸Morgantown, West Virginia, United States
UPMC Internal Medicine Recovery Engagement Program (IM-REP)
🇺🇸Pittsburgh, Pennsylvania, United States
Central City Concern (CCC)
🇺🇸Portland, Oregon, United States
OHSU Harm Reduction Bridges to Care (HRBR)
🇺🇸Portland, Oregon, United States
OHSU Internal Medicine Clinic (IMC)
🇺🇸Portland, Oregon, United States
Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center
🇺🇸Baltimore, Maryland, United States
Comprehensive Care Practice (CCP) - Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
Recovery Works Northwest (RWNW)
🇺🇸Portland, Oregon, United States
UPMC Latterman Family Health Center
🇺🇸McKeesport, Pennsylvania, United States
UPMC St. Margaret Family Health Center
🇺🇸New Kensington, Pennsylvania, United States
WVU Crisis Support & Recovery Center
🇺🇸Martinsburg, West Virginia, United States