Clinical trial NCT04248933: Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase
Official title: Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MAT Among Low-Income, Minority Individuals With OUD - Pilot Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Substance Use Disorders
Opioid-use Disorder
Peer Delivered
Medication for Opioid Use Disorder (MOUD)
Methadone Treatment
Retention in Care
Behavioral Activation
Keywords: Substance-Related Disorders
Medication Treatment for Opioid Use Disorder
Opioid Crisis
Epidemic, Opioid
Opioid Addiction
Treatment Adherence
Retention in Care
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-01-30
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) among low-income, minoritized individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this pilot trial, the investigators will evaluate the feasibility, acceptability, and fidelity of this approach (implementation outcomes) and preliminary effectiveness on methadone treatment retention at three months.

Detailed 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, 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 specialists (PRSs) may be uniquely suited to address these barriers to retention (Jack, 2017;Bassuk, 2016). PRSs are trained individuals who have a personal, lived experience with substance use. Using their lived experience, PRSs can support individuals with OUD to stay retained in care. Rapid increases in the use of PRSs nationwide demonstrate the appeal of employing PRSs as a potentially sustainable solution to support the behavioral treatment needs in OUD care. Yet, few evidence-based interventions have been evaluated for PRS 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 PRS-delivered BA intervention to support MOUD retention.

This study builds upon formative work to adapt and evaluate PRS-delivered BA to support MOUD retention for low-income, minoritized 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 PRS-delivered BA intervention for MOUD retention in methadone treatment, and evaluating retention in the methadone program at three months (primary effectiveness outcome).

Eligibility criteria: Inclusion Criteria:

* Initiated methadone at the study site or demonstrated challenges with methadone adherence in the past three months (e.g., at least one indicator of a missed methadone dose)
* Minimum of 18 years old

Exclusion Criteria:

* Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation
* Inability to understand the study and provide informed consent in English
* Positive pregnancy status at enrollment

Primary outcomes:
measure: MOUD Retention Rate: % of Patients Retained at 3 Months
timeFrame: Measured daily from intake to post-treatment (approximately 12-weeks)
measure: Intervention Feasibility: % of Patients Who Agree to Participate in the Intervention
timeFrame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Secondary outcomes:
measure: Intervention Acceptability: % of Patients Who Attend ≥75% Sessions
timeFrame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
measure: Intervention Fidelity: Percentage of Intervention Components Delivered by Peer as Intended
timeFrame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Other outcomes:
measure: Change in Opioid Use
timeFrame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
measure: Change in Methadone Use
timeFrame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
measure: Change in Depressive Symptoms
timeFrame: Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Locations:
city: Baltimore
country: United States
facility: University of Maryland Baltimore Drug Treatment Center
state: Maryland
city: College Park
country: United States
facility: University of Maryland, College Park
state: Maryland
Study officials:
affiliation: Assistant Professor
name: Jessica F Magidson, PhD
role: PRINCIPAL_INVESTIGATOR
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