N/A
N=150
Peer Intervention to Link Overdose Survivors to Treatment (PILOT)
Opioid Overdose
Bottom Line
View on ClinicalTrials.gov: NCT05123027 ↗Enrolled (actual)
150
Serious AEs
26.0%
Results posted
Feb 2025
Primary outcome: Primary: Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission — 4.5; 5.6 units on a scale — p=0.399
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer (Behavioral); Treatment As Usual Peer (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission |
4.5; 5.6 | 0.399 |
| SECONDARY Number of Steps Achieved Along a Modified SUD Cascade of Care |
4.4; 3.9 | 0.53 |
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 the Emergency Department.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT05123027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.