Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Behavioral Activation
  • Medication for Opioid Use Disorder (MOUD)
  • Methadone Maintenance
  • Opioid Use Disorder
  • Peer Delivered
  • Retention in Care
  • Substance Use
  • Substance Use Disorders
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Opioid use disorder (OUD) disproportionately affects low-income, racial/ethnic minorities (Stahler, 2018). MOUD is efficacious for treating OUD. However, adherence to MOUD is often low, which includes poor treatment retention, especially among low-income, racial/ethnic minority individuals (Stahler,...

Opioid use disorder (OUD) disproportionately affects low-income, racial/ethnic minorities (Stahler, 2018). MOUD is efficacious for treating OUD. However, adherence to MOUD is often low, which includes poor treatment retention, especially among low-income, racial/ethnic minority individuals (Stahler, 2018;Williams, 2017). This may be due to barriers such as stigma, challenges navigating services, housing instability, fluctuating motivation and readiness, and other structural and psychosocial factors (Timko, 2016;Carroll, 2015). Peer recovery coaches (PRCs) may be uniquely suited to address these barriers to retention (Jack, 2017;Bassuk, 2016). PRCs are trained individuals who have a personal, lived experience with substance use. Using their lived experience, PRCs can support individuals with OUD to stay retained in care. Rapid increases in the use of PRCs nationwide demonstrates the appeal of employing PRCs as a potentially sustainable solution to support the behavioral treatment needs in OUD care. Yet, few evidence-based interventions have been evaluated for PRC delivery to promote MOUD retention. Prior research has been inconclusive regarding psychosocial interventions to support MOUD retention (Timko, 2016;Carroll, 2017). Reinforcement-based approaches, such as contingency management, have empirical support for improving MOUD retention, but also can have low adoption in community settings due to organizational and provider barriers, including cost in medically underserved areas (Timko, 2016;Carroll, 2017;Carroll, 2015). Successful interventions need to be not only effective in improving MOUD retention, but also be feasible and sustainable to deliver for underserved populations. Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving MOUD retention for low-income, minority individuals with OUD (Magidson, 2011). Originally developed as an efficacious treatment for depression, BA aims to increase positive reinforcement by promoting engagement in adaptive, valued behaviors (Lejuez, 2011). By targeting increases in positive reinforcement, BA has been effective in improving substance use disorder (SUD) treatment retention and preventing future relapse among low-income, minority individuals with SUD. Further, BA has improved medication adherence (i.e., for HIV) among low-income, minority populations with SUD, as well as depression, which may also be a barrier to MOUD retention. Importantly for implementation, BA has previously been implemented in low-resource settings (largely internationally) using lay health workers (e.g., peers, community health workers). However, to date, prior work has yet to evaluate a PRC-delivered BA intervention to support MOUD retention. This study builds upon formative work to adapt and evaluate PRC-delivered BA to support MOUD retention for low-income, minority individuals initiating methadone at an outpatient, opioid treatment program in a medically underserved community in Baltimore, Maryland (Magidson, 2011;Magidson, 2018;Satinsky, 2020). The current study has three phases, the first being formative, qualitative work, to adapt the proposed treatment approach. The second phase is a pilot trial (current phase). The pilot trial is an open-label, Type 1 hybrid effectiveness-implementation trial assessing the feasibility, acceptability, and fidelity (implementation outcomes) of a PRC-delivered BA intervention for MOUD retention in methadone maintenance, and evaluating retention in the methadone program at three months (primary effectiveness outcome).

Tracking Information

NCT #
NCT04248933
Collaborators
  • University of Maryland, Baltimore
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Jessica F Magidson, PhD Assistant Professor