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

Opioid-Related Disorders Clinical Trial

— TTIP-PRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922959
• Other study ID #: 2016-6635
• Secondary ID: R34DA040862
• Status: Completed
• Phase: N/A
• Start date: February 7, 2017
• Est. completion date: July 25, 2019

Study information

• Verified date: June 2020
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 25, 2019
• Est. primary completion date: July 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Abuse
• Drug Addiction
• Drug Overdose
• Opioid-Related Disorders
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• Peer Intervention
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.

Drug:
• naloxone nasal spray kit
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.

Behavioral:
• Personally-tailored opioid overdose prevention education (information packet)
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.

Locations

Country	Name	City	State
United States	University of Cincinnati Addiction Sciences Division	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication-Assisted Treatment Enrollment	whether or not participant enrolled in medication-assisted treatment within the follow-up period	12 months
Secondary	Opioid Overdose Experience	whether or not participant experienced an opioid overdose within the follow-up period period.	12 months
Secondary	Change in Opioid Use (Timeline Follow-back)	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.	at 12-month visit
Secondary	Change in Opioid Use (Urine Drug Screen)	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.	at 12-month visit