Clinical trial NCT02922959: A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
Official title: A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Overdose
Opioid-Related Disorders
Drug Addiction
Drug Abuse
Substance Abuse
Keywords: Opioid Substitution Treatment
Telephone intervention
secondary prevention
naloxone
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-10-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Medication-Assisted Treatment Enrollment
timeFrame: 12 months
Secondary outcomes:
measure: Opioid Overdose Experience
timeFrame: 12 months
measure: Change in Opioid Use (Timeline Follow-back)
timeFrame: at 12-month visit
measure: Change in Opioid Use (Urine Drug Screen)
timeFrame: at 12-month visit
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Addiction Sciences Division
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Theresa Winhusen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.