N/A
N=80
A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
Drug Overdose · Opioid-Related Disorders · Drug Addiction · Drug Abuse · Substance Abuse
Bottom Line
View on ClinicalTrials.gov: NCT02922959 ↗Enrolled (actual)
80
Serious AEs
20.0%
Results posted
Jun 2020
Primary outcome: Primary: Medication-Assisted Treatment Enrollment — 7; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peer Intervention (Behavioral); naloxone nasal spray kit (Drug); Personally-tailored opioid overdose prevention education (information packet) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication-Assisted Treatment Enrollment |
7; 13 | — |
| SECONDARY Opioid Overdose Experience |
13; 5 | — |
| SECONDARY Change in Opioid Use (Timeline Follow-back) |
-10.2; -8.7 | — |
| SECONDARY Change in Opioid Use (Urine Drug Screen) |
18; 20 | — |
Summary
This project will further develop and test the Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid Overdoses (TTIP-PRO), a promising, low-cost, intervention to facilitate entry into medication assisted treatment (MAT) for individuals experiencing a non-fatal opioid overdoses (OOD). A prior small-scale pilot/feasibility study of TTIP-PRO (NCT02282306) found that the participating patients and the Peer Interventionists were satisfied with their participation, the intervention was acceptable, and the system for generating patient-tailored intervention information performed well. The overall goal of the present study is to conduct a pilot randomized controlled trial of TTIP-PRO versus a control group. It is hypothesized that patients in the TTIP-PRO group will have more favorable drug-abuse-related outcomes than patients in the control group.
Eligibility Criteria
Inclusion Criteria
- Report having been treated for an OOD within the past 6 months
- Age 18 years or older;
- Scores "high risk" for heroin and/or non-medical use of prescription opioids on the National Institute on Drug Abuse modified Alcohol, Smoking and Substance Involvement Screening Test (NIDA-modified ASSIST) (i.e., ≥ 27)
- Be able to understand the study, and having understood, provide written informed consent in English
- Access to a phone (for TTIP-PRO intervention and phone follow-up)
- Be willing to have their intervention audio recorded and rated if randomized to TTIP-PRO
- Have an opioid-positive baseline/screening urine drug screen.
Exclusion Criteria
- In the judgment of the investigator, would not be expected to complete the study protocol (e.g., due to relocation from the clinic area, probable incarceration, etc.)
- Current engagement in addiction treatment
- Residence more than 40 miles from the location of follow-up visits
- Inability to provide sufficient contact information (must provide at least 2 reliable locators)
- Prior participation in the current study.
Data sourced from ClinicalTrials.gov (NCT02922959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.