Peer Intervention to Link Overdose Survivors to Treatment (PILOT)

NCT05123027 | Completed Results DMC

• 2 other identifiers: 001034413UG1DA013727-20S5
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the Peer Intervention to Link Overdose Survivors to Treatment (PILOT) study is to improve outcomes for individuals after surviving an overdose involving opioids. This study will be comparing the enhanced peer intervention known as PILOT for overdose survivors with treatment as usual (TAU) provided in the Emergency Department.

Conditions

Opioid Overdose

Keywords

overdose; peer support

Outcome Measures

Primary Outcomes (1)

• Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission

  Past month total score on the modified Overdose Risk Behavior Checklist (OBRC) at 180 days (6 months post-randomization) compared between experimental groups. The ORBC was a 13-item scale with 11 of the items used to generate a total score (ranging from 0-44); higher scores indicate greater frequency and number of overdose risk behaviors.

  180 days (6 months)

Secondary Outcomes (1)

• Number of Steps Achieved Along a Modified SUD Cascade of Care

  180 days (6 months)

Study Arms (2)

Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer

EXPERIMENTAL

Behavioral: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer; Behavioral: Treatment As Usual Peer

Treatment As Usual Peer

ACTIVE COMPARATOR

Behavioral: Treatment As Usual Peer

Interventions

Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer BEHAVIORAL

Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation.

Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer

Treatment As Usual Peer BEHAVIORAL

Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.

Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer; Treatment As Usual Peer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Identified as having had an intentional overdose as the Index NFOO.
• Actively suicidal at the time of screening (defined as current intention and/or plan for suicide attempt).
• Unable to complete study baseline procedures due to medical or psychiatric condition.
• Currently in jail, prison or in police custody at the time of the index ED visit or under current terms of civil commitment or guardianship (i.e., OHRP-defined prisoner status).
• Previously randomized as a participant in this study - individuals may only be enrolled and randomized once.
• Unwilling to follow study procedures (e.g., unable to provide sufficient locator information \[defined as two contacts\] or unavailable for follow-up assessments).

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Drug Abuse Treatment Clinical Trials Network: collaborator
• The Emmes Company, LLC: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Mercy Health Youngstown

Youngstown, Ohio, 44501, United States

Location

Prisma Health Upstate

Greenville, South Carolina, 29605, United States

Location

Providence Regional Medical Center

Everett, Washington, 98201, United States

Location

Related Publications (1)

• Papa C, McClure EA, McCauley J, Haynes L, Matheson T, Jones R, Jennings L, Lawdahl T, Ward R, Brady K, Barth KS. Peer Intervention to Link Overdose Survivors to Treatment (PILOT): Protocol for a Multisite, Randomized Controlled Trial Conducted Within the National Institute on Drug Abuse Clinical Trials Network. JMIR Res Protoc. 2024 Sep 17;13:e60277. doi: 10.2196/60277.

  PMID: 39288373 DERIVED

MeSH Terms

Conditions

Opiate Overdose; Drug Overdose

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Ralph Ward
• Organization: Medical University of South Carolina

wardrc@musc.edu

843-876-6110

Study Officials

• Kelly Barth, DO

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 17, 2021
• Study Start: December 28, 2021
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: February 7, 2025
• Results First Posted: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)