A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses (TTIP-PRO)

• ClinicalTrials.gov Identifier: NCT02922959
• Recruitment Status: Completed
• First Posted: October 4, 2016
• Results First Posted: June 24, 2020
• Last Update Posted: June 24, 2020
• Sponsor: University of Cincinnati
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Theresa Winhusen, PhD, University of Cincinnati

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Drug Overdose; Opioid-Related Disorders; Drug Addiction; Drug Abuse; Substance Abuse	Behavioral: Peer Intervention; Drug: naloxone nasal spray kit; Behavioral: Personally-tailored opioid overdose prevention education (information packet)	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
• Actual Study Start Date: February 7, 2017
• Actual Primary Completion Date: July 25, 2019
• Actual Study Completion Date: July 25, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: PTOEND; PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution. Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.	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.; Other Name: NARCAN; 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.
Experimental: PTOEND+PI; PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention. In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer 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.; Other Name: NARCAN; 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.

Outcome Measures

Primary Outcome Measures :

1. Medication-Assisted Treatment Enrollment [ Time Frame: 12 months ]
   whether or not participant enrolled in medication-assisted treatment within the follow-up period

Secondary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Ohio

University of Cincinnati Addiction Sciences Division

Cincinnati, Ohio, United States, 45229

Sponsors and Collaborators

University of Cincinnati

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Theresa Winhusen, PhD; University of Cincinnati

  Study Documents (Full-Text)

Documents provided by Theresa Winhusen, PhD, University of Cincinnati:

Informed Consent Form  [PDF] August 8, 2018

Study Protocol and Statistical Analysis Plan  [PDF] November 8, 2017

More Information

• Responsible Party: Theresa Winhusen, PhD, Professor; Associate Vice Chair and Division Director of Addiction Sciences, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT02922959
• Other Study ID Numbers: 2016-6635; R34DA040862 ( U.S. NIH Grant/Contract )
• First Posted: October 4, 2016
• Results First Posted: June 24, 2020
• Last Update Posted: June 24, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data will be shared in a timely manner, i.e., no later than the acceptance for publication of the main findings from the final dataset. The dataset will include information about illegal activities (e.g., illicit opioid use, etc.). Thus, in addition to only a de-identified database being shared, we will also require a data sharing agreement. The data sharing agreement will require commitment to: 1) not re-disclose the data; 2) secure the data; 3) use the data for research purposes only; 4) make no attempt to identify individual participants; 5) destroy the data once the planned research activities have been completed; 6) follow all relevant NIH policies.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theresa Winhusen, PhD, University of Cincinnati:

Opioid Substitution Treatment; Telephone intervention; secondary prevention; naloxone

Additional relevant MeSH terms:

Substance-Related Disorders; Opioid-Related Disorders; Drug Overdose; Opiate Overdose; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Naloxone; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Narcotic Antagonists