Clinical trial NCT06367387: Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment
Official title: Pain Self-Management and Patient-Oriented Dosing for Pain and Retention in Office-based Addiction Treatment: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Opioid Use Disorder
Chronic Pain
Keywords: pain self-management
buprenorphine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-04-16
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants will be stratified by recruitment clinic and dose of buprenorphine at enrollment (≤16 mg vs \>16 mg) and randomized in 2x2 factorial design: 1) either to PSM or Usual Care, and then 2) either to POD or standard buprenorphine dosing. The randomization schema will be generated by the TREETOP Data Core using a stratified permuted block design and will be integrated into the web-based data collection and management system (REDCap).
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Adults at least 18 years old from participating clinics
2. Ability to speak, read, and understand English
3. Capable of providing informed consent
4. Access to phone and/or internet
5. Documented diagnosis of Opioid Use Disorder (OUD)
6. 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)
7. 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
8. Have high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Under 18 years of age
2. Have cancer-related pain
3. 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
4. Currently prescribed 32mg of an oral or sublingual buprenorphine mono or combination product
5. Currently prescribed an injectable formulation of buprenorphine
6. Pregnancy or intention to become pregnant within 4 months of enrollment
7. Currently prescribed naltrexone
8. 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.

Primary outcomes:
measure: Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline
timeFrame: Baseline, 3 Months
measure: Proportion of Participants Retained in buprenorphine Treatment at 3 months Post-baseline
timeFrame: 3 Months
Secondary outcomes:
measure: Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline
timeFrame: Baseline, 3 Months
measure: Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline
timeFrame: Baseline, 3 Months
measure: Proportion of Participants Taking any MOUD at 3-, 6-, 9- and 12-months Post-baseline
timeFrame: 3 Months, 6 Months, 9 Months, 12 Months
measure: Change from Baseline in Self-efficacy as Assessed by the PROMIS Self-Efficacy for Managing Symptoms SF-4a at 3 months Post-baseline
timeFrame: Baseline, 3 Months
measure: Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline
timeFrame: 3 Months
measure: Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline
timeFrame: 3 Months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Outpatient Addiction Treatment Services (OATS)
state: Maryland
city: Baltimore
country: United States
facility: Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center
state: Maryland
city: Baltimore
country: United States
facility: Comprehensive Care Practice (CCP) - Johns Hopkins Bayview Medical Center
state: Maryland
city: Hagerstown
country: United States
facility: Wells House
state: Maryland
city: Portland
country: United States
facility: Central City Concern (CCC)
state: Oregon
city: Portland
country: United States
facility: Recovery Works Northwest (RWNW)
state: Oregon
city: Portland
country: United States
facility: OHSU Harm Reduction Bridges to Care (HRBR)
state: Oregon
city: Portland
country: United States
facility: OHSU Internal Medicine Clinic (IMC)
state: Oregon
city: McKeesport
country: United States
facility: UPMC Latterman Family Health Center
state: Pennsylvania
city: New Kensington
country: United States
facility: UPMC St. Margaret Family Health Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Internal Medicine Recovery Engagement Program (IM-REP)
state: Pennsylvania
city: Martinsburg
country: United States
facility: WVU Crisis Support & Recovery Center
state: West Virginia
city: Morgantown
country: United States
facility: WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT)
state: West Virginia
Study officials:
affiliation: University of Pittsburgh
name: Jessica S Merlin, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: