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

Not Applicable

Completed

Conditions: Substance Abuse
Opioid-Related Disorders
Drug Abuse
Drug Overdose
Drug Addiction

Interventions: Behavioral: Peer Intervention
Drug: naloxone nasal spray kit
Behavioral: Personally-tailored opioid overdose prevention education (information packet)

Registration Number: NCT02922959

Lead Sponsor: University of Cincinnati

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTOEND+PI	naloxone nasal spray kit	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.
PTOEND	naloxone nasal spray kit	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 (information packet)	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.
PTOEND	Personally-tailored opioid overdose prevention education (information packet)	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	Peer Intervention	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.

Primary Outcome Measures

Name	Time	Method
Medication-Assisted Treatment Enrollment	12 months	whether or not participant enrolled in medication-assisted treatment within the follow-up period

Secondary Outcome Measures

Name	Time	Method
Opioid Overdose Experience	12 months	whether or not participant experienced an opioid overdose within the follow-up period period.
Change in Opioid Use (Timeline Follow-back)	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.
Change in Opioid Use (Urine Drug Screen)	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.