Clinical trial NCT05973838: Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention
Official title: Peer-Delivered, Behavioral Activation Intervention to Improve Polysubstance Use and Retention in Mobile Telemedicine OUD Treatment in an Underserved, Rural Area
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polysubstance Addiction
Opioid Medication Assisted Treatment
Treatment Adherence
Retention in Care
Substance-Related Disorders
Keywords: Substance-Related Disorders
Opioid-Related Disorders
Polysubstance Use
Mental disorders
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore
name: Weill Medical College of Cornell University
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-08-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in parallel to receive either the Peer Activate intervention on the MTU or enhanced treatment as usual (TAU: treatment as usual services on the MTU in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at a midpoint (1-month), and follow ups at 3-month, 6-month and 12-months following the baseline assessment. Follow up assessments will be conducted by a blinded assessor.
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) and reduce polysubstance use among patients with OUD and polysubstance use in an underserved, rural area. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the investigators will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over twelve months.

Detailed description: There is a significant burden of opioid and polysubstance use, disproportionately affecting underserved, rural areas of the US. Yet many rural communities are poorly equipped to meet the pressing need for addiction treatment, including medications for OUD (MOUD) and evidence-based interventions (EBIs) to address the rise in opioid use disorder (OUD) and co-occurring stimulant use.The availability of telemedicine aboard a mobile treatment unit (TM-MTU), led by University of Maryland Baltimore in partnership with Maryland Department of Health, has helped fill the void of rural practitioners by providing buprenorphine for OUD treatment in rural areas, however, OUD treatment retention remains an ongoing challenge, with polysubstance use and stimulant use exacerbating this. Peer recovery specialists (PRSs), trained individuals with their own lived experience with substance use disorder (SUD) and recovery, are a promising strategy to improve OUD treatment retention and polysubstance use via the TM-MTU using a reinforcement-based approach.

Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving OUD treatment retention and reducing polysubstance use in rural areas. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, including for stimulant use specifically, 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. BA has been shown to be feasibly delivered by peers and community health workers.

This study proposes to evaluate the effectiveness, implementation, and cost-effectiveness of an adapted PRS-delivered BA approach on the TM-MTU ("Peer Activate-MTU") compared to enhanced treatment as usual (ETAU; facilitated referrals and general PRS support) for patients with OUD and other polysubstance use. The investigators propose a randomized Type 1 hybrid effectiveness-implementation trial (n=180) to evaluate Peer Activate-MTU compared to ETAU. Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on polysubstance use, as well as OUD treatment retention and buprenorphine adherence. The investigators will also evaluate the implementation of Peer-Active-MTU, including feasibility, acceptability, fidelity, and adoption guided by RE-AIM.

Eligibility criteria: Inclusion Criteria:

Patient participants in the RCT must be 18 or older; receive OUD treatment as part of the telemedicine program; and exhibit polysubstance use within the past three-months (i.e., use of one or more non-prescribed substances (excluding opioids and/or tobacco) by urine toxicology or self-report.

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

Primary outcomes:
measure: Six-Month Polysubstance Use Urinalysis
timeFrame: Measured from baseline to 6-month follow-up
measure: Six-Month Polysubstance Use Self Report
timeFrame: Assessed between the baseline assessment 6-month follow-up
Secondary outcomes:
measure: Six-month OUD Treatment Retention
timeFrame: Measured from intake through 6-month follow up
measure: Six-month Buprenorphine Adherence
timeFrame: Measured from intake to six-month follow-up
measure: Six-month Self-Report Buprenorphine Adherence
timeFrame: Assessed between the baseline assessment and 6-month follow-up
measure: Six-Month Problems Associated with Substance Use
timeFrame: Assessed between the baseline assessment and 6-month follow-up
measure: Intervention Uptake
timeFrame: Assessed between the baseline assessment and 6-month follow-up
measure: Intervention Session Attendance
timeFrame: Assessed between the baseline assessment 6-month follow-up
measure: Intervention Fidelity
timeFrame: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)
Other outcomes:
measure: Three-month OUD Treatment Retention
timeFrame: Measured from intake through 3-month follow up
measure: Three-Month Polysubstance Use Urinalysis
timeFrame: Measured from baseline to 3-month follow-up.
measure: Three-Month Polysubstance Use Self Report
timeFrame: Measured from baseline to 3-month follow-up.
measure: Three-Month Problems Associated with Substance Use
timeFrame: Assessed between baseline assessment and 3-month follow-up.
measure: Three-month Buprenorphine Adherence
timeFrame: Measured over 3 months
measure: Three-month Self-Report Buprenorphine Adherence
timeFrame: Assessed between the baseline assessment and 3-month follow-up
measure: Twelve-month OUD Treatment Retention
timeFrame: Measured from intake through 12-month follow up
measure: Twelve-Month Polysubstance Use Urinalysis
timeFrame: Measured from baseline to 12-month follow-up.
measure: Twelve-Month Polysubstance Use Self Report
timeFrame: Measured from baseline to 12-month follow-up.
measure: Twelve-Month Problems Associated with Substance Use
timeFrame: Assessed between the baseline and 12-month follow-up.
measure: Twelve-month Buprenorphine Adherence
timeFrame: Measured over 12 months
measure: Twelve-month Self-Report Buprenorphine Adherence
timeFrame: Assessed between the baseline assessment and 12-month follow-up
measure: Six-month Treatment Cost
timeFrame: Measured from baseline to 6-month follow-up
measure: Six-month Healthcare Resource Utilization
timeFrame: Measured from baseline to 6-month follow-up
measure: Six-month Health-related Quality of Life
timeFrame: Measured from baseline to 6-month follow-up
measure: Six-month Non-Medical and Other Resource Utilization
timeFrame: Measured from baseline to 6-month follow-up
measure: Six-month Criminal and Legal Activities
timeFrame: Measured from baseline to 6-month follow-up
measure: Overdose risk
timeFrame: Measured from baseline to 6-month follow-up
Locations:
city: Baltimore
country: United States
facility: University of Maryland Baltimore (UMD Drug Treatment Center)
state: Maryland
city: College Park
country: United States
facility: University of Maryland, College Park
state: Maryland
city: Denton
country: United States
facility: Caroline County Behavioral Health
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Jessica F Magidson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Baltimore
name: Sarah M Kattakuzhy, MD
role: PRINCIPAL_INVESTIGATOR
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