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Completed

NCT Number: NCT02922959

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

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.

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Key information

Conditions

Drug Overdose Chemically-Induced Disorders Drug Abuse Drug Addiction Drug Misuse Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Prescription Drug Misuse Substance Abuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati Addiction Sciences Division

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peer Intervention

Behavioral

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 kit

Drug

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.

Other names: NARCAN

Personally-tailored opioid overdose prevention education (information packet)

Behavioral

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 outcomes

  1. Medication-Assisted Treatment Enrollment

    Time frame: 12 months

    whether or not participant enrolled in medication-assisted treatment within the follow-up period

Secondary outcomes

  1. Opioid Overdose Experience

    Time frame: 12 months

    whether or not participant experienced an opioid overdose within the follow-up period period.

  2. Change in Opioid Use (Timeline Follow-back)

    Time frame: 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.

  3. Change in Opioid Use (Urine Drug Screen)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: TTIP-PRO

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2016
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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