NCT02282306

Brief Summary

There has been a dramatic rise in opioid overdose (OOD) deaths in recent years. Attempts to ameliorate the problem have largely focused on increasing the accessibility of naloxone, an opioid antagonist that is effective in OOD reversal. Individuals who have experienced a non-fatal OOD are at risk for additional overdoses and yet there are no interventions that specifically target this high-risk population. To address this gap, the investigators have developed the "Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid Overdoses" (TTIP-PRO). The overall goal of the present study is to conduct a pilot evaluation of the TTIP-PRO. The research literature suggests the need for an intervention targeting patients experiencing a non-fatal OOD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

October 30, 2014

Last Update Submit

May 27, 2015

Conditions

OverdoseOpioid-related DisordersDrug AddictionDrug AbuseSubstance AbuseOpioid Use, UnspecifiedOpioid DependenceDrug Overdose

Outcome Measures

Primary Outcomes (1)

  • Study Acceptability (proportion of patients who: a). call about the study and b). agree to participate in the study and c). who complete the study.)

    Acceptability of the study will be assessed based on the proportion of patients who: a). call about the study and b). agree to participate in the study and c). who complete the study. Acceptability of the study will be further assessed by peer interventionists who: a). complete the training and b). complete the study (i.e. continue to successfully provide intervention to assigned participants through the end of the study).

    6 months

Secondary Outcomes (1)

  • Impact of TTIP-PRO on knowledge about Opioid Overdose. (will be assessed with a paired difference test (e.g., paired t-test))

    6 months

Study Arms (1)

TTIP-PRO

OTHER

Patients who have experienced an OOD in the past 8 months will be eligible to receive TTIP-PRO. A letter about the study will be sent to those patients. Interested patients will call the UC Health staff working on this study. The intervention entails administering the Personal Opioid-Overdose Risk Survey and the Opioid Overdose and Treatment Awareness Survey to the patient. The TTIP-PRO computer program uses the information to generate the "Personal Feedback Report", which is used by the Peer Interventionist to provide the intervention. The TTIP-PRO computer program also creates the "Personal Risk Factors Report" which is mailed to the participant with some other helpful information.

Behavioral: TTIP-PRO

Interventions

TTIP-PROBEHAVIORAL

The peer-delivered TTIP-PRO intervention is designed to: 1). increase the patient's knowledge of risk factors for OOD, with a particular emphasis on the patient's personal risk factors. This aim is one of harm reduction and is intended to help patients who continue to abuse opioids to use in a safer manner and 2).For patients who are open to considering treatment, to encourage the patient to get treatment for his/her opioid use disorder. This goal is based on research findings that effective treatment reduces the risk of OOD.

TTIP-PRO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have been treated for an OOD by the UCMC ED within the prior 8 months
  • have used heroin and/or abused prescription opioids in the prior 12 months
  • be 18 years of age or older at time of enrollment
  • be able to provide verbal consent to participate in English

You may not qualify if:

  • demonstrate difficulty understanding the study as assessed with four true-false questions (i.e., 1. This is a research study; 2. Your participation is entirely voluntary; 3. You will be asked questions about your risk of opioid overdose.; 4. Your participation will involve several phone calls).
  • be 18 years of age or older at time of enrollment
  • be enrolled in a methadone-maintenance or buprenorphine- maintenance treatment program for at least one year
  • report being opioid-abstinent for at least one year
  • meet at least one of the following: has experienced/witnessed/lost a family member or friend to an overdose
  • be able to provide informed consent in English
  • have significant treatment/clinical concerns as determined by treatment program staff
  • The primary pool of potential Peer Interventionists will be patients enrolled in the UC Health (University of Cincinnati Physicians Company) methadone-maintenance or buprenorphine- maintenance treatment programs. Recruitment will be through clinic postings and word of mouth. It is estimated that 2-3 Peer Interventionists will be enrolled in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

3131 Harvey Avenue, Suite 104

Cincinnati, Ohio, 45229, United States

Location

UC Physicians Company, LLC Opioid Treatment Program

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • Winhusen T, Theobald J, Lewis D, Wilder CM, Lyons MS. Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). Health Educ Res. 2016 Apr;31(2):146-60. doi: 10.1093/her/cyw010.

    PMID: 27004905DERIVED

MeSH Terms

Conditions

Drug OverdoseOpioid-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Prescription Drug MisuseDrug MisuseChemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Study Officials

  • Theresa Winhusen, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 4, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(2)