Opioid Addiction, Opioid Medication Assisted Treatment, Opioid Use, Opioid Use Disorder, Retention in Care, Substance-Related Disorders, Treatment Adherence
Conditions
Keywords
Disease, Substance-Related Disorders, Opioid-Related Disorders, Mental Disorders
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, minority 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 Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT), we will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over six months.
Detailed description
The opioid use disorder (OUD) crisis disproportionately affects low-income, racial/ethnic minorities. There is a pressing need to improve retention in medication for opioid use disorder (MOUD), particularly among low-income, racial/ethnic minorities. Training peer recovery specialists (PRSs), individuals with their own lived experience with substance use disorder (SUD), in evidence-based interventions (EBIs) may be a promising strategy to improve MOUD retention for low-income, minority individuals with OUD. Yet, few EBIs have been evaluated for PRS delivery to promote MOUD retention. Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving MOUD retention for low-income, minority individuals with OUD. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, and improving medication adherence (i.e., for HIV) among low-income, minority populations with SUD as well as depression, which is a barrier to MOUD retention. Importantly for implementation, BA also is feasible and cost-effective using lay counselor delivery. Following from this prior research, BA is an ideal EBI to evaluate for improving MOUD retention using a PRS-delivered model. This Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT) builds upon our team's formative work, as well as our recent open label-pilot (R61AT010799) to develop and pilot the PRS-delivered BA approach. Guided by Aarons' stage model and Proctor's model of implementation, we proposed a mixed-methods, Type 1 hybrid effectiveness-implementation study to evaluate implementation and the effectiveness of the intervention on MT retention.
Interventions
The PRS-delivered Peer Activate intervention will consist of approximately four weekly core sessions (approximately 30 minutes-1 hour) with two additional sessions to reinforce core content, and then 6 optional booster sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to assist in their retention and persistence in methadone treatment and incorporating value-driven, substance-free, rewarding activities into their daily life.
Sponsors
University of Maryland, Baltimore
Henry Ford Health System
University of Maryland, College Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
At the approximately 3-Month (or at completion/discontinuation of intervention) and approximately 6-Month Follow-Up assessments (or approximately 3 months after 3-month follow up assessment or at discontinuation of intervention), a trained and blinded member of the research team will complete assessments with the participant.
Intervention model description
Participants will be randomized in parallel to receive either the Peer Activate intervention or treatment as usual (TAU: weekly group and individual counseling with an addiction counselor in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at an approximately 3-month follow-up (or at completion/discontinuation of the intervention), and at an approximately 6-month follow-up (or at 3 months after completion/discontinuation of the intervention).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Initiated methadone at the study site in the past three months (and no less than two weeks prior to study enrollment) or demonstrated challenges with methadone adherence in the past three months as indicated by one or more of the following: a) at least one missing take-home bottle at the time of bottle return; b) screened negative for methadone in routinely administered clinic urinalysis tests; c) transitioned from an extended take-home bottle schedule to daily dosing schedule; or d) at least one missed methadone dose in the past 3 months as identified through clinic records * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MT Persistence | Measured at final follow up (approximately six-months post-baseline) | Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period) |
| MT Retention | Measured at final follow up (approximately six-months post-baseline assessment) | Defined dichotomously as retention (yes/no) in methadone treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability Measured by Intervention Attendance | Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment) | Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, we will measure the % of patients enrolled who attend ≥75% sessions. We will also collect qualitative feedback relating to acceptability. |
| Intervention Fidelity Measured by Independent Rating | Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment) | Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and we will assess the % of intervention components delivered as intended. |
| MT Persistence | Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment) | Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period) |
| Changes in substance use | Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline) | Assess prevalence of opioid use and other substance use (urinalysis and timeline follow back) |
| MT Retention | Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment) | Defined dichotomously as retention (yes/no) in methadone treatment |
| Intervention Feasibility Measured by Intervention Initiation | Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment) | Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention. We will also collect qualitative feedback relating to feasibility. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms | Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline) | Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms. |
| Changes in substance use | Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline) | Assess prevalence of opioid use and other substance use (urinalysis and timeline followback) |
Countries
United States
Outcome results
None listed