Peer Intervention to Link Overdose Survivors to Treatment (PILOT)

Opioid Overdose Clinical Trial

— PILOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05123027
• Other study ID #: 00103441
• Secondary ID: 3UG1DA013727-20S
• Status: Completed
• Phase: N/A
• Start date: December 28, 2021
• Est. completion date: February 8, 2024

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 the Emergency Department.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 8, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Drug Overdose
• Opiate Overdose
• Opioid Overdose

Intervention

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

Locations

Country	Name	City	State
United States	Providence Regional Medical Center	Everett	Washington
United States	Prisma Health Upstate	Greenville	South Carolina
United States	Mercy Health Youngstown	Youngstown	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Drug Abuse Treatment Clinical Trials Network, National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)