Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
University of Maryland, College Park
Study ID
NCT05973838
Status
Recruiting

Conditions

  • Opioid Medication Assisted Treatment
  • Polysubstance Addiction
  • Retention in Care
  • Substance-Related Disorders
  • Treatment Adherence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Peer-Delivered Behavioral Activation ("Peer Activate") — BEHAVIORAL
    The PRS-delivered Peer Activate intervention will consist of approximately six weekly "core" sessions (approximately 30 minutes-1 hour), and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to reduce barriers to medication nonadherence and incorporate value-driven, substance-free, rewarding activities into their daily life to reduce polysubstance use and improve retention.

Study Details

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 underserved areas. 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.

Key Dates

Start date
Jun 15, 2023
Status verified
Apr 2026
Primary completion
Jul 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Peer-Delivered Behavioral Activation ("Peer Activate")
    Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use.
  • No Intervention: Treatment As Usual
    Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed.

Primary Outcome Measure

Six-Month Polysubstance Use Urinalysis [ Time Frame: Measured from baseline to 6-month follow-up ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
HIPS ClinicWashington D.C.District of Columbia20002
Sarah M. Kattakuzhy, MD
443-691-4638
University of Maryland Baltimore (UMD Drug Treatment Center)BaltimoreMaryland21223
Heather Fitzsimons
443-462-3400
Sarah M Kattakuzhy, MD (PRINCIPAL_INVESTIGATOR)
Eric Weintraub, MD (SUB_INVESTIGATOR)
Annabelle M Belcher, PhD (SUB_INVESTIGATOR)
University of Maryland, College ParkCollege ParkMaryland20742
Morgan S Anvari, BA
3014055095
Jessica F Magidson, PhD
301-405-5095
Jessica F Magidson, PhD (PRINCIPAL_INVESTIGATOR)
Caroline County Behavioral HealthDentonMaryland21629
Jessica Tuel, MSW
410-479-8172

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