An interventional study of Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer and Treatment As Usual Peer in Opioid Overdose, sponsored by Medical University of South Carolina. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Prevention
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.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
This study's enrollment of 150 is below the median of 184 across 48 interventional studies indexed under Opiate Overdose.
Browse Opiate Overdose studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be included in this study participants must:
Meet one of the following non-fatal overdose involving opioids (NFOO) criteria:
Exclusion criteria include those who are:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer · Behavioral: Treatment As Usual Peer
Behavioral: Treatment As Usual Peer
Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation.
Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.
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.
Time frame: 180 days (6 months)
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.
Time frame: 180 days (6 months)
A randomized, controlled, parallel group design was implemented across three sites within the National Drug Abuse Treatment Clinical Trials Network (CTN): Prisma Health Systems (Southern Consortium Node); Mercy Health (Ohio Valley Node), and Providence Regional Medical Center (Pacific Northwest Node). From December 2021 through February 2024, 150 participants identified in the ED as opioid overdose survivors were approached to participate in the study.
| Milestone | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Treatment As Usual Peer |
|---|---|---|
| Started | 72 | 78 |
| Completed | 48 | 50 |
| Not completed | 24 | 28 |
| Withdrew: Lost to follow-up | 17 | 22 |
| Withdrew: Incarceration | 3 | 4 |
| Withdrew: Death | 2 | 2 |
| Withdrew: Other | 2 | 0 |
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.
| units on a scale | PILOT Intervention Arm | Treatment as Usual (TAU) Arm |
|---|---|---|
| Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission | 4.5 ± 6.7 | 5.6 ± 7.8 |
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.
| units on a scale | PILOT Intervention Arm | Treatment as Usual (TAU) Arm |
|---|---|---|
| Number of Steps Achieved Along a Modified SUD Cascade of Care | 4.4 ± 2.6 | 3.9 ± 2.5 |
Collected over 28 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | 2/72 (2.8%) | 21/72 (29.2%) | 0/72 (0%) |
| Treatment As Usual Peer | 2/78 (2.6%) | 18/78 (23.1%) | 0/78 (0%) |
| Event | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Treatment As Usual Peer |
|---|---|---|
| DeathInjury, poisoning and procedural complications | 1/72 | 0/78 |
| DeathGeneral disorders | 1/72 | 0/78 |
| HospitalizationSurgical and medical procedures | 1/72 | 0/78 |
| HospitalizationInfections and infestations | 1/72 | 0/78 |
| HospitalizationPregnancy, puerperium and perinatal conditions | 1/72 | 0/78 |
| HospitalizationInjury, poisoning and procedural complications | 1/72 | 0/78 |
| HospitalizationRespiratory, thoracic and mediastinal disorders | 1/72 | 0/78 |
| HospitalizationPsychiatric disorders | 1/72 | 0/78 |
| HospitalizationInjury, poisoning and procedural complications | 1/72 | 0/78 |
| HospitalizationPsychiatric disorders | 1/72 | 0/78 |
| Age, Categorical(Participants) | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Treatment As Usual Peer | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 70 | 76 | 146 |
| >=65 years | 2 | 2 | 4 |
| Age, Continuous(years) | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Treatment As Usual Peer | Total |
|---|---|---|---|
| Mean | 39.3 ± 11.58 | 38.1 ± 11.28 | 38.7 ± 11.41 |
| Sex: Female, Male(Participants) | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Treatment As Usual Peer | Total |
|---|---|---|---|
| Female | 21 | 30 | 51 |
| Male | 51 | 48 | 99 |
| Ethnicity (NIH/OMB)(Participants) | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Treatment As Usual Peer | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 8 | 14 |
| Not Hispanic or Latino | 66 | 70 | 136 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Treatment As Usual Peer | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 2 | 5 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 12 | 23 |
| White | 51 | 53 | 104 |
| More than one race | 2 | 6 | 8 |
| Unknown or Not Reported | 5 | 5 | 10 |
| Baseline ORBC score(units on a scale) | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Treatment As Usual Peer | Total |
|---|---|---|---|
| Mean | 12.6 ± 7.4 | 12 ± 7.9 | 12.3 ± 7.7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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).
Ran from Dec 2021 to primary completion in Feb 2024, 25 months.
Results were first posted in Feb 2025, 11 months after primary completion.
Of 28 interventional studies with no phase under Opiate Overdose, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's 25 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina →