Peer Intervention to Link Overdose Survivors to Treatment (PILOT)

NCT ID: NCT05123027

Last Updated: 2025-02-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-28

Study Completion Date

2024-02-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Overdose

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Treatment As Usual Peer

Intervention Type BEHAVIORAL

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

Treatment As Usual Peer

Group Type ACTIVE_COMPARATOR

Treatment As Usual Peer

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Treatment As Usual Peer

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Drug Abuse Treatment Clinical Trials Network

NETWORK

Sponsor Role collaborator

The Emmes Company, LLC

INDUSTRY

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kelly Barth

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kelly Barth, DO

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mercy Health Youngstown

Youngstown, Ohio, United States

Site Status

Prisma Health Upstate

Greenville, South Carolina, United States

Site Status

Providence Regional Medical Center

Everett, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39288373 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3UG1DA013727-20S5

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00103441

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Emergency Department Longitudinal Integrated Care
NCT05327166 ACTIVE_NOT_RECRUITING NA
Mobile Peer Support for OUD Recovery
NCT05405712 ACTIVE_NOT_RECRUITING NA
Safety & Prevention Outcomes Study
NCT01894087 COMPLETED NA