A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/17/2018 |
| Start Date: | February 7, 2017 |
| End Date: | July 2019 |
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.
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.
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.
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:
- Inability to participate due to emergency treatment
- 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.
We found this trial at
1
site
3131 Harvey Avenue
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
Phone: 513-725-6329
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