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

NIDA CTN-0107 Peer Intervention to Link Overdose Survivors to Treatment (PILOT)

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.

Study Overview

• Status: Completed
• Conditions: Opioid Overdose
• Intervention / Treatment: Behavioral: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer; Behavioral: Treatment As Usual Peer

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin McClure, PhD; Phone Number: 843-792-7192; Email: mccluree@musc.edu
• Study Contact Backup: Name: Carrie Papa, MBA; Phone Number: 843-876-1507; Email: papa@musc.edu

Study Locations

• United States
  • Ohio
    • Youngstown, Ohio, United States, 44501
      • Mercy Health Youngstown
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Upstate
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

To be included in this study participants must:

1. Be 18 years of age or older at time of first contact by research staff (no upper age limit for inclusion).

2. Meet one of the following non-fatal overdose involving opioids (NFOO) criteria:

   1. Having presented to the Emergency Department for any health issue within the past 48 hours AND self-report having a known or suspected overdose involving opioids in the past 72 hours, OR
   2. Having presented to the Emergency Department within the past 48 hours for any SUD-related health issue, self-report having a known or suspected overdose involving opioids in the past 30 days
3. Be able to provide sufficient locator information, defined as identifying at least two individual contacts other than the participant.
4. Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study as determined by research staff.
5. Be willing and able to confirm future SUD treatment receipt as evidenced by 2 out of 3 of the following: (a) signing appropriate releases to for study staff to confirm treatment with follow-up provider; (b) having technology necessary to visualize medication bottles and transmit to study team utilizing HIPAA-compliant platform; and/or (c) able and willing to undergo toxicology tests (in person or via HIPAA-compliant videoconferencing).

Exclusion criteria include those who are:

1. Identified as having had an intentional overdose as the Index NFOO.
2. Actively suicidal at the time of screening (defined as current intention and/or plan for suicide attempt).
3. Unable to complete study baseline procedures due to medical or psychiatric condition.
4. 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).
5. Previously randomized as a participant in this study - individuals may only be enrolled and randomized once.
6. Unwilling to follow study procedures (e.g., unable to provide sufficient locator information [defined as two contacts] or unavailable for follow-up assessments).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer	Behavioral: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer; Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation.; Behavioral: Treatment As Usual Peer; Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.
Active Comparator: Treatment As Usual Peer	Behavioral: Treatment As Usual Peer; Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 at 180 days (6 months post-randomization) compared between experimental groups.	180 days (6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of steps achieved along a modified SUD Cascade of Care	Number of steps achieved along a modified Substance Use Disorder (SUD) Cascade of Care (0-11 steps possible) at 180 days post-randomization (6 months).	180 days (6 months)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA); The Emmes Company, LLC; National Drug Abuse Treatment Clinical Trials Network
• Investigators: Principal Investigator: Kelly Barth, DO, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Actual): February 8, 2024
• Study Completion (Actual): February 8, 2024

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: overdose; peer support
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Drug Overdose; Opiate Overdose
• Other Study ID Numbers: 00103441; 3UG1DA013727-20S5 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study will comply with the NIH Data Sharing Policy and Implementation Guidance (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm) and the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No