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

Primary Purpose

Drug Overdose, Opioid-Related Disorders, Drug Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Intervention
naloxone nasal spray kit
Personally-tailored opioid overdose prevention education (information packet)
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug Overdose focused on measuring Opioid Substitution Treatment, Telephone intervention, secondary prevention, naloxone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Cincinnati Addiction Sciences Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PTOEND

PTOEND+PI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Medication-Assisted Treatment Enrollment
whether or not participant enrolled in medication-assisted treatment within the follow-up period

Secondary Outcome Measures

Opioid Overdose Experience
whether or not participant experienced an opioid overdose within the follow-up period period.
Change in Opioid Use (Timeline Follow-back)
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.
Change in Opioid Use (Urine Drug Screen)
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.

Full Information

First Posted
September 30, 2016
Last Updated
June 4, 2020
Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02922959
Brief Title
A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
Acronym
TTIP-PRO
Official Title
A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
July 25, 2019 (Actual)
Study Completion Date
July 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Overdose, Opioid-Related Disorders, Drug Addiction, Drug Abuse, Substance Abuse
Keywords
Opioid Substitution Treatment, Telephone intervention, secondary prevention, naloxone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PTOEND
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PTOEND+PI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Intervention
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
naloxone nasal spray kit
Other Intervention Name(s)
NARCAN
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personally-tailored opioid overdose prevention education (information packet)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication-Assisted Treatment Enrollment
Description
whether or not participant enrolled in medication-assisted treatment within the follow-up period
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Opioid Overdose Experience
Description
whether or not participant experienced an opioid overdose within the follow-up period period.
Time Frame
12 months
Title
Change in Opioid Use (Timeline Follow-back)
Description
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.
Time Frame
at 12-month visit
Title
Change in Opioid Use (Urine Drug Screen)
Description
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.
Time Frame
at 12-month visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Winhusen, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Addiction Sciences Division
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34236298
Citation
Kropp F, Wilder C, Theobald J, Lewis D, Winhusen TJ. The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. Subst Abus. 2022;43(1):527-530. doi: 10.1080/08897077.2021.1949667. Epub 2021 Jul 8.
Results Reference
derived

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

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