A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses (TTIP-PRO)

June 4, 2020 updated by: Theresa Winhusen, PhD, University of Cincinnati
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pilot study is a randomized controlled intent-to-treat (ITT) clinical trial. Approximately eighty eligible participants will be randomized in a 1:1 ratio to the control condition (Information and NARCAN® (naloxone) Nasal Spray kit) or to the experimental condition (TTIP-PRO in addition to the elements provided in the control condition). All participants will complete a follow-up phone call approximately 3-weeks post-randomization, during which process measures will be completed, and in-person visits at approximately 3, 6-, and 12-months following enrollment.

This is a single site study; all data will be collected at the University of Cincinnati. Approximately 80 participants will be randomized into this pilot efficacy trial. The hypotheses to be tested include that participants assigned to the TTIP-PRO intervention will: have a higher rate of enrollment in MAT, have a lower rate of recurring opioid overdose, and have greater reduction in illicit opioid use.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • University of Cincinnati Addiction Sciences Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PTOEND

PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.

Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.
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.
Other Names:
  • NARCAN
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.
Experimental: PTOEND+PI

PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.

In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.
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.
Other Names:
  • NARCAN
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication-Assisted Treatment Enrollment
Time Frame: 12 months
whether or not participant enrolled in medication-assisted treatment within the follow-up period
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Overdose Experience
Time Frame: 12 months
whether or not participant experienced an opioid overdose within the follow-up period period.
12 months
Change in Opioid Use (Timeline Follow-back)
Time Frame: at 12-month visit
Difference in self-reported opioid use in the prior 28 days, from Baseline to 12-month visit, computed as: (12-month opioid use days - Baseline opioid use days); negative values indicate a reduction in self-reported opioid use days from Baseline to 12-month visit.
at 12-month visit
Change in Opioid Use (Urine Drug Screen)
Time Frame: at 12-month visit
Number of participants who provided an opioid-negative urine sample, assessed by a rapid urine drug screen system, at the 12-month visit. Results that were positive, but specific to only buprenorphine or methadone, were counted as negative for participants with verified enrollment in medication-assisted treatment. Note that all participants were required to have an opioid-positive urine sample at Baseline, in order to be eligible for the study.
at 12-month visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2017

Primary Completion (Actual)

July 25, 2019

Study Completion (Actual)

July 25, 2019

Study Registration Dates

First Submitted

September 30, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-6635
  • R34DA040862 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared in a timely manner, i.e., no later than the acceptance for publication of the main findings from the final dataset. The dataset will include information about illegal activities (e.g., illicit opioid use, etc.). Thus, in addition to only a de-identified database being shared, we will also require a data sharing agreement. The data sharing agreement will require commitment to: 1) not re-disclose the data; 2) secure the data; 3) use the data for research purposes only; 4) make no attempt to identify individual participants; 5) destroy the data once the planned research activities have been completed; 6) follow all relevant NIH policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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