Evaluation of a Novel Intervention to Prevent Polysubstance Overdoses Involving Illicit Stimulants

NCT05493475 | Completed

• 1 other identifier: Nationwide Children's Hospital
• Study Type: interventional
• Target: 653
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the feasibility, acceptability, and associated benefits and harms of integrating FTS education and distribution into select courts in rural and urban communities in Ohio.

Conditions

Opiate Overdose; Fentanyl Overdose; Harm Reduction

Outcome Measures

Primary Outcomes (6)

• Key informant interviews

  Key informant interviews will be conducted with court personnel and peer recovery mentors who are affiliated with the court sites to discuss and obtain feedback on the intervention design and research protocols. Key informants will be asked to provide feedback on participant recruitment strategies, discuss potential barriers to the program's success, and describe any concerns with the implementation plan. Quantitative Data/Process Measures: * \# interested court sites * \# Court sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTSED and OEND at baseline * \# replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire

  Quarter 2 of Year 1

• Follow-up questionnaire

  A follow-up questionnaire will occur with intervention arm site personnel to gauge satisfaction with the program and identify any concerns. Quantitative Data/Process Measures: * \# interested court sites * \# Court sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTSED and OEND at baseline * \# replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire

  Quarter 3 of Year 3

• Interview

  Intervention arm site personnel will be interviewed to identify barriers and facilitating factors related to offering FTS education and distribution at OEND sites. Quantitative Data/Process Measures: * \# interested court sites * \# Court sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTSED and OEND at baseline * \# replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire

  Quarter 2 of Year 3

• Interview

  Intervention arm sites will be interviewed about the acceptability of the program. Quantitative Data/Process Measures: * \# interested court sites * \# Court sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTSED and OEND at baseline * \# replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire

  6-month follow-up

• Questionnaire

  All participants (in both the intervention and non-intervention arms) will complete a questionnaire at enrollment (for the intervention group, prior to the intervention) and again at 6 months. Both questionnaires (baseline and 6 months) will include the same questions about the participant's knowledge of and self-efficacy in reducing their risk of an opioid overdose by using FTS.

  6-month follow-up

• Questionnaire

  Participants in the intervention arm will be contacted biweekly for 2 years and asked if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Intervention arm participants will be asked to notify the study team when they receive a positive FTS result. Participants in the non-intervention arm will be contacted biweekly up to a maximum of 2 years after enrollment to ask if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Fatal overdoses among participants in the intervention and non-intervention arms of the study will be identified by reviewing death certificates issued by the Ohio Department of Health quarterly starting in Year 2.

  Quarter 3 of Year 3

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Each participant in the intervention arm will receive one-on-one education on the purpose, benefits, and limitations of fentanyl test strip (FTS) testing and undergo a brief 20-minute FTS educational intervention (including a 2-3-minute video and hands-on demonstrations on how to use FTS). They will also receive a supply of 10 FTS upon enrollment and continued supply upon request throughout the 2-year follow up period. Each participant will also receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period.

Behavioral: Fentanyl Test Strips

Non-Intervention Arm

NO INTERVENTION

Each participant will receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period. Fentanyl test strip (FTS) education and a supply of FTS will be offered to participants in the non-intervention arm of the study during the final quarter of year 3.

Interventions

Fentanyl Test Strips BEHAVIORAL

A brief fentanyl test strip (FTS) education intervention will be given to participants at court sites in the intervention arm after enrollment and collecting baseline data. It will be offered one-on-one with participants and will include the purpose, benefits, and limitations of FTS testing, and information on how to use FTS, interpret the results, what to do if the FTS is positive, and how to use FTS for different drug delivery methods. Participants will practice and demonstrate use of the FTS, and the short video on how to interpret the FTS will include an on-camera statement on the importance of testing for fentanyl. The video will be accessible to participants after study enrollment. Participants will be advised of the possibility of both false positive/negative results, and that the drugs may be mixed with other substances not detectable with FTS. Participants will be encouraged to practice other harm reduction strategies.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Not incarcerated at time of study enrollment
• Currently enrolled in one of the following Ohio drug courts: Criminal drug court, Veterans' court, Mental health court, Human trafficking court, Family treatment court, O.V.I. court or on probation with a participating court
• Self-reported use of illicit stimulants in the past 6 months
• Has a phone number or email address to allow for follow-up contact
• Understands English (Based on the 2012-2016 American Community Survey, only 2.4% of Ohioans 5 years and older speak English less than "very well.")

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43207, United States

Location

MeSH Terms

Conditions

Opiate Overdose; Harm Reduction

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders; Behavior

Study Officials

• Nichole Michaels, PhD

  Nationwide Children's Hospital, Center for Injury Research & Policy

  PRINCIPAL INVESTIGATOR

• Gary Smith, MD, DRPH

  Nationwide Children's Hospital, Center for Injury Research & Policy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 9, 2022
• Study Start: November 10, 2022
• Primary Completion: August 30, 2025
• Study Completion: September 29, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests may be submitted starting 12 months after publication and will be made available for up to 24 months.
• Access Criteria: Researchers with an approved data use agreement and statistical analysis plan.

Locations

US (1)