Peer Intervention to Link Overdose Survivors to Treatment (PILOT)

Study Overview
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Brief Summary
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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.

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

Conditions
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Opioid Overdose

Intervention / Treatment
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* Behavioral: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer
* Behavioral: Treatment As Usual Peer


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer<br> | Behavioral: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer<br>* Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation.<br>Behavioral: Treatment As Usual Peer<br>* Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.<br>|
| Active Comparator: Treatment As Usual Peer<br> | Behavioral: Treatment As Usual Peer<br>* Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 at 180 days (6 months post-randomization) compared between experimental groups. | 180 days (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 180 days (6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overdose, peer support