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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)

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

NCT ID

NCT02922959

First Posted

September 30, 2016

Last Updated

June 4, 2020

Sponsor

University of Cincinnati

Collaborators

National Institute on Drug Abuse (NIDA)

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

Studies a U.S. FDA-regulated Device Product

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

Arm Title

PTOEND+PI

Arm Type

Experimental

Arm Description

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

Time Frame

at 12-month visit

Title

Change in Opioid Use (Urine Drug Screen)

Description

Time Frame

at 12-month visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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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