A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
TTIP-PRO
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedStudy Start
First participant enrolled
February 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2019
CompletedResults Posted
Study results publicly available
June 24, 2020
CompletedJune 24, 2020
June 1, 2020
2.5 years
September 30, 2016
June 4, 2020
June 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication-Assisted Treatment Enrollment
whether or not participant enrolled in medication-assisted treatment within the follow-up period
12 months
Secondary Outcomes (3)
Opioid Overdose Experience
12 months
Change in Opioid Use (Timeline Follow-back)
at 12-month visit
Change in Opioid Use (Urine Drug Screen)
at 12-month visit
Study Arms (2)
PTOEND
ACTIVE COMPARATORPTOEND: 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
EXPERIMENTALPTOEND+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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cincinnatilead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
University of Cincinnati Addiction Sciences Division
Cincinnati, Ohio, 45229, United States
Related Publications (1)
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.
PMID: 34236298DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Theresa Winhusen
- Organization
- University of Cincinnati Addiction Sciences Division
Study Officials
- PRINCIPAL INVESTIGATOR
Theresa Winhusen, PhD
University of Cincinnati
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor; Associate Vice Chair and Division Director of Addiction Sciences
Study Record Dates
First Submitted
September 30, 2016
First Posted
October 4, 2016
Study Start
February 7, 2017
Primary Completion
July 25, 2019
Study Completion
July 25, 2019
Last Updated
June 24, 2020
Results First Posted
June 24, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
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.