A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses

NCT02922959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-06-24

Study results available
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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.

Conditions

  • Drug Overdose
  • Opioid-Related Disorders
  • Drug Addiction
  • Drug Abuse
  • Substance Abuse

Interventions

BEHAVIORAL

Peer Intervention

The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets. The primary goal of the call is for the participant and the Peer Interventionist to have an open exchange of information about medication-assisted treatment (MAT) for opioid use disorder.

DRUG

naloxone nasal spray kit

Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to the patient participants, which may be useful in the event of a future opioid overdose.

BEHAVIORAL

Personally-tailored opioid overdose prevention education (information packet)

Personally-tailored information packet with three participant-specific reports ("Personal Overdose Risk Factors Report"; "Medication Assisted Treatment (MAT) Report"; and the "Opioid Overdose Information Report"), and general written information about opioid overdose and treatment for opioid use disorder.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Theresa Winhusen, PhD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-07
Primary Completion
2019-07-25
Completion
2019-07-25

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02922959 on ClinicalTrials.gov