Opioid-Related Disorders Clinical Trial
Official title:
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.
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.
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