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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05123027
Recruitment Status : Recruiting
First Posted : November 17, 2021
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
National Drug Abuse Treatment Clinical Trials Network
The Emmes Company, LLC
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kelly S. Barth, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Opioid Overdose Behavioral: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer Behavioral: Treatment As Usual Peer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: NIDA CTN-0107 Peer Intervention to Link Overdose Survivors to Treatment (PILOT)
Actual Study Start Date : December 28, 2021
Estimated Primary Completion Date : May 15, 2023
Estimated Study Completion Date : June 15, 2023

Arm Intervention/treatment
Experimental: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer 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.

Behavioral: Treatment As Usual Peer
Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.

Active Comparator: Treatment As Usual Peer Behavioral: Treatment As Usual Peer
Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.




Primary Outcome Measures :
  1. Number of self-reported overdose risk behaviors at 180 days (6 months) after Index ED admission [ Time Frame: 180 days (6 months) ]
    Past month total score on the modified Overdose Risk Behavior Checklist at 180 days (6 months post-randomization) compared between experimental groups.


Secondary Outcome Measures :
  1. Number of steps achieved along a modified SUD Cascade of Care [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05123027


Contacts
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Contact: Erin McClure, PhD 843-792-7192 mccluree@musc.edu
Contact: Carrie Papa, MBA 843-876-1507 papa@musc.edu

Locations
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United States, Ohio
Mercy Health Youngstown Not yet recruiting
Youngstown, Ohio, United States, 44501
Contact: Suzette Miller, MSN    330-480-6958    smiller3@mercy.com   
United States, South Carolina
Prisma Health Upstate Recruiting
Greenville, South Carolina, United States, 29605
Contact: Alain Litwin, MD       Alain.Litwin@prismahealth.org   
United States, Washington
Providence Regional Medical Center Not yet recruiting
Everett, Washington, United States, 98201
Contact: Thomas Robey, MD       terobey@northsoundem.com   
Sponsors and Collaborators
Medical University of South Carolina
National Drug Abuse Treatment Clinical Trials Network
The Emmes Company, LLC
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kelly Barth, DO Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Kelly S. Barth, Medical University of South Carolina:
Informed Consent Form  [PDF] June 16, 2021

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Responsible Party: Kelly S. Barth, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT05123027    
Other Study ID Numbers: 00103441
3UG1DA013727-20S5 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This study will comply with the NIH Data Sharing Policy and Implementation Guidance (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm) and the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kelly S. Barth, Medical University of South Carolina:
overdose
peer support
Additional relevant MeSH terms:
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Drug Overdose
Opiate Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Opioid-Related Disorders
Narcotic-Related Disorders
Mental Disorders