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Completed

NCT Number: NCT05123027

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mercy Health Youngstown, Youngstown, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

To be included in this study participants must:

  • Be 18 years of age or older at time of first contact by research staff (no upper age limit for inclusion).
  • Meet one of the following non-fatal overdose involving opioids (NFOO) criteria:
  • 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
  • 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
  • Be able to provide sufficient locator information, defined as identifying at least two individual contacts other than the participant.
  • 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.
  • 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:

  • 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).

Treatment and study plan

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.

Treatment As Usual Peer

Behavioral

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

Primary outcomes

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

    Time frame: 180 days (6 months)

    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.

Secondary outcomes

  1. Number of Steps Achieved Along a Modified SUD Cascade of Care

    Time frame: 180 days (6 months)

    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). Higher scores are associated with better outcomes.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Drug Abuse Treatment Clinical Trials Network
  • National Institute on Drug Abuse (NIDA)
  • The Emmes Company, LLC

Registry information

Official study title

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

Acronym: PILOT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2021
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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