Trial Outcomes & Findings for Peer Intervention to Link Overdose Survivors to Treatment (PILOT) (NCT NCT05123027)

Last Updated: 2025-02-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

150 participants

Primary outcome timeframe

180 days (6 months)

Results posted on

2025-02-07

Participant Flow

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.

Participants were identified and recruited from the ED at the time of ED admission (primary method of recruitment). Recruitment, approaching patients, screening, consent, and study procedures were completed in-person or remotely, utilizing HIPAA-compliant videoconferencing. Participants could be approached, screened and randomized after ED admission and could be randomized after screening had occurred in the ED.

Participant milestones

Participant milestones
Measure	Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer 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.	Treatment As Usual Peer Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.
Overall Study STARTED	72	78
Overall Study COMPLETED	48	50
Overall Study NOT COMPLETED	24	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer 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.	Treatment As Usual Peer Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.
Overall Study Lost to Follow-up	17	22
Overall Study Incarceration	3	4
Overall Study Death	2	2
Overall Study Other	2	0

Baseline Characteristics

Peer Intervention to Link Overdose Survivors to Treatment (PILOT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer n=72 Participants 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.	Treatment As Usual Peer n=78 Participants Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=99 Participants	76 Participants n=107 Participants	146 Participants n=206 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Age, Continuous	39.3 years STANDARD_DEVIATION 11.58 • n=99 Participants	38.1 years STANDARD_DEVIATION 11.28 • n=107 Participants	38.7 years STANDARD_DEVIATION 11.41 • n=206 Participants
Sex: Female, Male Female	21 Participants n=99 Participants	30 Participants n=107 Participants	51 Participants n=206 Participants
Sex: Female, Male Male	51 Participants n=99 Participants	48 Participants n=107 Participants	99 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=99 Participants	8 Participants n=107 Participants	14 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=99 Participants	70 Participants n=107 Participants	136 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	11 Participants n=99 Participants	12 Participants n=107 Participants	23 Participants n=206 Participants
Race (NIH/OMB) White	51 Participants n=99 Participants	53 Participants n=107 Participants	104 Participants n=206 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	6 Participants n=107 Participants	8 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants
Baseline ORBC score	12.6 units on a scale STANDARD_DEVIATION 7.4 • n=99 Participants	12 units on a scale STANDARD_DEVIATION 7.9 • n=107 Participants	12.3 units on a scale STANDARD_DEVIATION 7.7 • n=206 Participants

PRIMARY outcome

Timeframe: 180 days (6 months)

Population: Intent to treat analysis. All randomized subjects were included in the analysis. A participant contributed to the Day 180 estimate if they had all fixed effect covariates including baseline ORBC score and an ORBC score at Day 180

Outcome measures

Outcome measures
Measure	PILOT Intervention Arm n=72 Participants In addition to usual care steps (TAU arm), also meets in the ED and over the next 180 days with PILOT peer with specialized training in overdose survivor engagement.	Treatment as Usual (TAU) Arm n=78 Participants Receives routine clinical treatment in the ED including TAU peer support specialists able to provide Screening, Brief Intervention, Referral to Treatment (SBIRT) interventions for patients presenting with substance use disorders or substance-related issues.
Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission	4.5 units on a scale Standard Deviation 6.7	5.6 units on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: 180 days (6 months)

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.

Outcome measures

Outcome measures
Measure	PILOT Intervention Arm n=72 Participants In addition to usual care steps (TAU arm), also meets in the ED and over the next 180 days with PILOT peer with specialized training in overdose survivor engagement.	Treatment as Usual (TAU) Arm n=78 Participants Receives routine clinical treatment in the ED including TAU peer support specialists able to provide Screening, Brief Intervention, Referral to Treatment (SBIRT) interventions for patients presenting with substance use disorders or substance-related issues.
Number of Steps Achieved Along a Modified SUD Cascade of Care	4.4 units on a scale Standard Deviation 2.6	3.9 units on a scale Standard Deviation 2.5

Adverse Events

Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer

Serious events: 21 serious events

Other events: 0 other events

Deaths: 2 deaths

Treatment As Usual Peer

Serious events: 18 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer n=72 participants at risk 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.	Treatment As Usual Peer n=78 participants at risk Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.
General disorders Death	1.4% 1/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	0.00% 0/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
Cardiac disorders Death	0.00% 0/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	1.3% 1/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
Injury, poisoning and procedural complications Death	1.4% 1/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	0.00% 0/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
Psychiatric disorders Hospitalization	1.4% 1/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	0.00% 0/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
Injury, poisoning and procedural complications Hospitalization	1.4% 1/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	0.00% 0/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
Respiratory, thoracic and mediastinal disorders Hospitalization	1.4% 1/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	0.00% 0/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
Infections and infestations Hospitalization	1.4% 1/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	0.00% 0/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
General disorders Hospitalization	1.4% 1/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	0.00% 0/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
Social circumstances Hospitalization	0.00% 0/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	1.3% 1/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
Cardiac disorders Hospitalization	0.00% 0/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	1.3% 1/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
Surgical and medical procedures Hospitalization	1.4% 1/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	0.00% 0/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
Pregnancy, puerperium and perinatal conditions Hospitalization	1.4% 1/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	0.00% 0/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.
Renal and urinary disorders Hospitalization	1.4% 1/72 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.	0.00% 0/78 • 28 weeks Given the low-risk nature of this study, only select Adverse Events (AEs) and Serious Adverse Events (SAEs), collectively termed Safety Events were tracked and reported. Accordingly, Safety Events associated with participant death, post-index overdoses, ED visits, and hospitalizations were solicited during the 30-, 90-, 180-, and 210-day visits (or in-between visits if reported spontaneously). Reporting timeframes for Safety Events followed regulatory requirements.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ralph Ward

Medical University of South Carolina

Phone: 843-876-6110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place