Retention in treatment is one of the most critical problems facing patients in bup/nx-based office based addiction treatment (OBAT), and strategies to improve retention are urgently needed. Even though most patients with OUD have chronic pain, and undermanaged pain is an important factor in return to use, pain is not typically addressed in OUD treatment. Our Retention research project posits that treating pain and OUD at the same time will improve pain outcomes and help people stay engaged with addiction treatment. This project is innovative in several important ways:
- Developing a standardized flex-bup protocol: While flex-bup is commonly used in clinical practice, scientific literature evaluating this approach is limited and has not been developed or evaluated in a systematic approach.
- Tailoring PSM to OBAT: To our knowledge, this has not yet been reported in the literature.
- Leveraging pain treatment to improve OBAT retention: Using chronic pain treatment to improve OBAT retention outcomes is highly patient-centered.
- Developing measures of retention in OBAT: Accurate measurement is key to assessing retention, but there are no standard approaches to retention measurement in OBAT. We will draw from HIV literature and involve an HIV retention expert to examine several approaches to evaluating retention outcome and compare information gleaned from each approach.
Principal Investigator: Dr. Jessica Merlin
Specific Aims
- Aim 1: Tailor evidence-based pain self-management (PSM) and flexible Buprenorphine/Naloxone (flex-bup) treatments to individuals with chronic pain receiving office-based addiction treatment (OBAT). We will use intervention mapping, a systematic, theory-based, qualitative approach to tailoring existing behavioral interventions to new populations. We will use the Health Equity Implementation Framework to investigate potential barriers and facilitators.
- Aim 2: Evaluate both the effectiveness and the barriers to and facilitators of implementation of PSM-OBAT and flex-bup in OBAT. We will use a 2x2 factorial Hybrid Type 1 trial design to separately evaluate the effectiveness of PSM-OBAT and flex-bup among individuals with chronic pain and OUD who have been on a stable dose of bup/nx for at least 2 weeks.
- Aim 3: Evaluate the cost effectiveness of PSM-OBAT and flex-bup compared with enhanced usual care.
Research Sites
Pennsylvania
Pennsylvania recruitment sites are located in Allegheny and five surrounding counties, which include urban and rural populations. Pennsylvania is #5 in the US in age-adjusted overdose deaths (35.6/100,000) and in 2020, Allegheny County reported 586 overdose deaths, reversing a previously decreasing trend. Deaths are predominantly in white males and are driven by fentanyl and heroin. This pattern is repeated in most of the surrounding counties.
Participating Clinics: UPMC Internal Medicine Recovery Engagement Program (IM-REP)
Research Team: Dr. Hailey Bulls (Co-PI), Dr. Jane Liebschutz (Co-I)
West Virginia
Retention project participants from West Virginia will be recruited from clinics across the state. Central Appalachia is one of the US epicenters of the opioid epidemic and West Virginia has consistently led the US in age-adjusted opioid overdose deaths. Due to the state’s almost entirely rural composition, West Virginians face significant barriers to both addiction and chronic pain treatment.
Participating Clinics: Cabin Creek Health Systems, Comprehensive Opioid Addiction Treatment (COAT)
Research Team: Dr. Erin Winstanley (Site PI)
Oregon
Three clinical sites affiliated with Oregon Health & Science University (OHSU) and the Western States Node of the NIDA CTN will serve as recruitment sites for the Retention project. Based on data from Oregon.gov, in 2018, there were 8 overdose deaths per 100,000 Oregonians, a trend that has leveled off over the past decade. Overdoses are mainly related to heroin and pharmaceutical opioids, with fentanyl not far behind. There was an increase in overdose deaths in 2020 that may be attributable to the COVID-19 pandemic and is driven by fentanyl. In May 2020, opioids were involved in 73% of overdose deaths, including fentanyl in 40%.
Participating Clinics: OHSU, Central City Concern, Recovery Works NW
Research Team: Dr. Jonathan Robbins (Site PI), Dr. Todd Korthuis (Site PI), Dr. Brian Chan (Co-I), Dr. Benjamin Morasco (Co-I)
Maryland (Baltimore)
The Retention project will recruit participants from two urban OBATs in Baltimore, MD. In the US, Maryland has the highest absolute number of opioid-related deaths in non-Hispanic Black individuals and is #4 in age-adjusted overdose deaths, with these deaths concentrated in Baltimore. Particular challenges faced by Black communities include lack of access to treatment, intersecting stigma of minority status and OUD, legitimate fears of legal consequences, intergenerational poverty, and lack of respectful care, among others.
Participating Clinics: Comprehensive Care Practice (CCP), East Baltimore Medical Center (EBMC)
Research Team: Dr. Deanna Wilson (Co-I)