Drug OverdoseTTIP-PRONCT02922959

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

A study testing Peer Intervention, naloxone nasal spray kit and Personally-tailored opioid overdose prevention education (information packet) in people with Drug Overdose and Opioid-Related Disorders, run by University of Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Drug Overdose, Opioid-Related Disorders, Drug Addiction
What is being tested?: Peer Intervention, naloxone nasal spray kit and Personally-tailored opioid overdose prevention education (information packet)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 7 Feb 2017to 25 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Cincinnati Addiction Sciences Division
Cincinnati, Ohio, 45229

Other trials in United States

About this study

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.

Read the 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.

Conditions: Drug Overdose, Opioid-Related Disorders, Drug Addiction, Drug Abuse, Substance Abuse
Being tested: Peer Intervention, naloxone nasal spray kit, Personally-tailored opioid overdose prevention education (information packet)
Keywords: Opioid Substitution Treatment, Telephone intervention, secondary prevention, naloxone
Medical subject headings: Drug Overdose, Opioid-Related Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peer InterventionBehavioural
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.
naloxone nasal spray kitDrug
Also called NARCAN
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.
Personally-tailored opioid overdose prevention education (information packet)Behavioural
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.

Study groups in NCT02922959
Study group	Role	What they receive
PTOEND	Active comparator	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. Receives: Drug: naloxone nasal spray kit; Behavioral: Personally-tailored opioid overdose prevention education (information packet)
PTOEND+PI	Experimental	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. Receives: Behavioral: Peer Intervention; Drug: naloxone nasal spray kit; Behavioral: Personally-tailored opioid overdose prevention education (information packet)

What is being measured

The primary outcome is the main question the study is designed to answer.

Medication-Assisted Treatment Enrollment
whether or not participant enrolled in medication-assisted treatment within the follow-up period
Measured: 12 months

Secondary outcomes (3)

Opioid Overdose Experience
whether or not participant experienced an opioid overdose within the follow-up period period.
Measured: 12 months
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.
Measured: at 12-month visit
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.
Measured: at 12-month visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 201725 Jul 2019

First posted4 Oct 2016 (estimated)
Study start7 Feb 2017
Primary completion25 Jul 2019
Study completion25 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Drug OverdoseStudies of the same condition, open and under way.
More trials run by University of CincinnatiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02922959
Sponsor's protocol ID: 2016-6635
Other IDs: R34DA040862
Acronym: TTIP-PRO
Status last verified: Jun 2020
First submitted: 30 Sep 2016
Last updated: 24 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Kropp F, Wilder C, Theobald J, Lewis D, Winhusen TJ. The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. Subst Abus. 2022;43(1):527-530. doi: 10.1080/08897077.2021.1949667. Epub 2021 Jul 8.
PubMed 34236298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Drug Overdose trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
ClinicalTrials.gov ID: NCT02922959
Acronym / sponsor ID: TTIP-PRO / 2016-6635
Conditions: Drug Overdose, Opioid-Related Disorders, Drug Addiction, Drug Abuse, Substance Abuse
Keywords: Opioid Substitution Treatment, Telephone intervention, secondary prevention, naloxone
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: University of CincinnatiUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 7 Feb 2017 (actual)
Primary completion: 25 Jul 2019 (actual)
Study completion: 25 Jul 2019 (actual)
First posted: 4 Oct 2016 (estimated)
Results: Posted 24 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PTOEND	Active comparator	Drug: naloxone nasal spray kit, Behavioral: Personally-tailored opioid overdose prevention education (information packet)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.
PTOEND+PI	Experimental	Behavioral: Peer Intervention, Drug: naloxone nasal spray kit, Behavioral: Personally-tailored opioid overdose prevention education (information packet)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peer InterventionThe 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.	Behavioural	PTOEND+PI
naloxone nasal spray kitAlso: NARCANNaloxone 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.	Drug	PTOEND, PTOEND+PI
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.	Behavioural	PTOEND, PTOEND+PI

Primary outcome

Medication-Assisted Treatment Enrollment
Time frame: 12 months
whether or not participant enrolled in medication-assisted treatment within the follow-up period

3 secondary outcomes

Opioid Overdose Experience
Time frame: 12 months
Change in Opioid Use (Timeline Follow-back)
Time frame: at 12-month visit
Change in Opioid Use (Urine Drug Screen)
Time frame: at 12-month visit

Results and safety

Results posted to the registry on 24 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PTOEND	40	21
PTOEND+PI	40	23

Primary outcome: Medication-Assisted Treatment Enrollment

Time frame: 12 months. Count of participants. Unit: Participants

Measure	PTOEND n = 40	PTOEND+PI n = 40
Value	7	13

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Adverse events were systematically assessed during each research visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PTOEND	9 of 40 (22.5%)	0 of 40 (0%)	0 of 40
PTOEND+PI	7 of 40 (17.5%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34236298Kropp F, Wilder C, Theobald J, Lewis D, Winhusen TJ. The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. Subst Abus. 2022;43(1):527-530. doi: 10.1080/08897077.2021.1949667. Epub 2021 Jul 8.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Theresa Winhusen, PhD principal investigator

University of Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication-Assisted Treatment Enrollment (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02922959, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.