Opioid OverdosePILOTNCT05123027

Peer Intervention to Link Overdose Survivors to Treatment (PILOT)

A study testing Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer and Treatment As Usual Peer in people with Opioid Overdose, run by Medical University of South Carolina at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid Overdose
What is being tested?: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer and Treatment As Usual Peer
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 3 sitesUnited States
Study dates: 28 Dec 2021to 8 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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

Conditions: Opioid Overdose
Being tested: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer, Treatment As Usual Peer
Keywords: overdose, peer support
Medical subject headings: Opiate Overdose, Drug Overdose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peer Intervention to Link Overdose Survivors to Treatment (PILOT) PeerBehavioural
Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation.
Treatment As Usual PeerBehavioural
Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.

Study groups in NCT05123027
Study group	Role	What they receive
Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer	Experimental	Not described Receives: Behavioral: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer; Behavioral: Treatment As Usual Peer
Treatment As Usual Peer	Active comparator	Not described Receives: Behavioral: Treatment As Usual Peer

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 180 days (6 months)

Secondary outcomes (1)

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). Higher scores are associated with better outcomes.
Measured: 180 days (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Dec 20218 Feb 2024

First posted17 Nov 2021
Study start28 Dec 2021
Primary completion8 Feb 2024
Study completion8 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid OverdoseStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05123027
Sponsor's protocol ID: 00103441
Other IDs: 3UG1DA013727-20S5
Acronym: PILOT
Status last verified: Jan 2025
First submitted: 26 Oct 2021
Last updated: 7 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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).

Publications

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.
PubMed 39288373

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual

All Opioid Overdose trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NIDA CTN-0107 Peer Intervention to Link Overdose Survivors to Treatment (PILOT)
ClinicalTrials.gov ID: NCT05123027
Acronym / sponsor ID: PILOT / 00103441
Conditions: Opioid Overdose
Keywords: overdose, peer support
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: National Drug Abuse Treatment Clinical Trials Network, The Emmes Company, LLC, National Institute on Drug Abuse (NIDA)
Study start: 28 Dec 2021 (actual)
Primary completion: 8 Feb 2024 (actual)
Study completion: 8 Feb 2024 (actual)
First posted: 17 Nov 2021 (actual)
Results: Posted 7 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peer Intervention to Link Overdose Survivors to Treatment (PILOT) PeerParticipants will meet with the PILOT Peer consistently throughout the 6 months of study participation.	Behavioural	Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer
Treatment As Usual PeerParticipants will receive recovery resources and standard of care procedures specific to the Emergency Department.	Behavioural	Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer, Treatment As Usual Peer

Primary outcome

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.

1 secondary outcome

Number of Steps Achieved Along a Modified SUD Cascade of Care
Time frame: 180 days (6 months)

Results and safety

Results posted to the registry on 7 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer	72	48
Treatment As Usual Peer	78	50

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

Time frame: 180 days (6 months). Mean (Standard Deviation). Unit: units on a scale

Measure	PILOT Intervention Arm n = 72	Treatment as Usual (TAU) Arm n = 78
Value	4.5 (6.7)	5.6 (7.8)

Treatment as Usual (TAU) Arm: Risk Ratio (RR): 0.70 (95% CI 0.30 to 1.62), p = 0.399, Mixed Models Analysis

Population analysed: Intent to treat analysis. All randomized subjects were included in the analysis. A participant contributed to the Day 180 estimate if they had all fixed effect covariates including baseline ORBC score and an ORBC score at Day 180

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 28 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer	21 of 72 (29.2%)	0 of 72 (0%)	2 of 72
Treatment As Usual Peer	18 of 78 (23.1%)	0 of 78 (0%)	2 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39288373Papa 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.
Individual participant dataSharing planned: No. 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).

Related trials for Opioid Overdose

Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kelly Barth, DO principal investigator

Medical University of South Carolina

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission (time frame: 180 days (6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05123027, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.