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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922959
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Theresa Winhusen, PhD, University of Cincinnati

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.

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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

Resource links provided by the National Library of Medicine


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.




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 3-month, 6-month, and 12-month visits ]
    self-reported opioid use in the prior 28 days

  3. Change in Opioid Use (Urine drug screen) [ Time Frame: at 3-month, 6-month, and 12-month visits ]
    assessed by a rapid urine drug screen system



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922959


Locations
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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
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Principal Investigator: Theresa Winhusen, PhD University of Cincinnati

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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    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 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.

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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:
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Substance-Related Disorders
Opioid-Related Disorders
Drug Overdose
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Naloxone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists