Clinical trial NCT05123027: Peer Intervention to Link Overdose Survivors to Treatment (PILOT)
Official title: NIDA CTN-0107 Peer Intervention to Link Overdose Survivors to Treatment (PILOT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Overdose
Keywords: overdose
peer support
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Drug Abuse Treatment Clinical Trials Network
name: The Emmes Company, LLC
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-11-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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:

1. Be 18 years of age or older at time of first contact by research staff (no upper age limit for inclusion).
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 include those who are:

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).

Primary outcomes:
measure: Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission
timeFrame: 180 days (6 months)
Secondary outcomes:
measure: Number of Steps Achieved Along a Modified SUD Cascade of Care
timeFrame: 180 days (6 months)
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Mercy Health Youngstown
state: Ohio
city: Greenville
country: United States
facility: Prisma Health Upstate
state: South Carolina
city: Everett
country: United States
facility: Providence Regional Medical Center
state: Washington
Study officials:
affiliation: Medical University of South Carolina
name: Kelly Barth, DO
role: PRINCIPAL_INVESTIGATOR
References: