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

• Sponsor: University of Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT02922959
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 29.5
• Patients Per Site Per Month: 2.7

Study Details

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)	N/A

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
• 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: Feb 7, 2017
• Actual Primary Completion Date: Jul 25, 2019
• Actual Study Completion Date: Jul 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 Names: 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 Names: 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 [12 months]

   whether or not participant enrolled in medication-assisted treatment within the follow-up period

Secondary Outcome Measures

1. Opioid Overdose Experience [12 months]

   whether or not participant experienced an opioid overdose within the follow-up period period.

2. Change in Opioid Use (Timeline Follow-back) [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) [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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)

• Informed Consent Form - Aug 8, 2018
• Study Protocol and Statistical Analysis Plan - Nov 8, 2017

More Information

Publications

None provided.

• 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
• First Posted: Oct 4, 2016
• Last Update Posted: Jun 24, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Theresa Winhusen, PhD, Professor; Associate Vice Chair and Division Director of Addiction Sciences, 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; Naloxone

Study Results

Participant Flow

Recruitment Details	Potential participants were recruited through various methods including advertisements, flyers, and word-of-mouth. Greater than 90% of participants were recruited from a syringe exchange program. All participants were given a thorough explanation of the study and signed an informed consent form.
Pre-assignment Detail	116 potential participants were consented and screened, and 80 were randomized to Personally-tailored opioid overdose education and naloxone distribution plus Peer Intervention (PTOEND+PI) (n=40) or PTOEND (n=40).

Arm/Group Title	PTOEND	PTOEND+PI
Arm/Group Description	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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.	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. 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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.
Period Title: Overall Study
STARTED	40	40
3 Weeks	38	36
3 Months	35	31
6 Months	28	30
12 Months	21	23
COMPLETED	21	23
NOT COMPLETED	19	17

Baseline Characteristics

Arm/Group Title	PTOEND	PTOEND+PI	Total
Arm/Group Description	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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.	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. 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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.	Total of all reporting groups
Overall Participants	40	40	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.0 (10.3)	40.3 (12.5)	39.1 (11.4)
Sex: Female, Male (Count of Participants)
Female	22 55%	14 35%	36 45%
Male	18 45%	26 65%	44 55%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.5%	1 2.5%	2 2.5%
Not Hispanic or Latino	39 97.5%	39 97.5%	78 97.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 12.5%	5 12.5%	10 12.5%
White	32 80%	32 80%	64 80%
More than one race	3 7.5%	3 7.5%	6 7.5%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PTOEND	PTOEND+PI
Arm/Group Description	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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.	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. 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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.
Measure Participants	40	40
Count of Participants [Participants]	7 17.5%	13 32.5%

2. Secondary Outcome

Title	Opioid Overdose Experience
Description	whether or not participant experienced an opioid overdose within the follow-up period period.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PTOEND	PTOEND+PI
Arm/Group Description	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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.	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. 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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.
Measure Participants	40	40
Count of Participants [Participants]	13 32.5%	5 12.5%

3. Secondary Outcome

Title	Change in Opioid Use (Timeline Follow-back)
Description	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.
Time Frame	at 12-month visit

Outcome Measure Data

Analysis Population Description

Analysis could only be done on data provided by participants who attended the 12-month visit

Arm/Group Title	PTOEND	PTOEND+PI
Arm/Group Description	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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.	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. 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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.
Measure Participants	21	23
Mean (Standard Deviation) [days]	-10.2 (12.7)	-8.7 (13.6)

4. Secondary Outcome

Title	Change in Opioid Use (Urine Drug Screen)
Description	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.
Time Frame	at 12-month visit

Outcome Measure Data

Analysis Population Description

Analysis could only be done on samples provided by participants who attended the 12-month visit

Arm/Group Title	PTOEND	PTOEND+PI
Arm/Group Description	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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.	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. 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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.
Measure Participants	21	23
Count of Participants [Participants]	18 45%	20 50%

Adverse Events

Time Frame	12 months. Adverse events were systematically assessed during each research visit.
Adverse Event Reporting Description	Serious Adverse Events were defined as an event that results in any of the following outcomes: death, life threatening, requires hospitalization, initial or prolonged, results in disability, congenital anomaly, requires intervention to prevent permanent impairment or damage, or other significant medical event. Other (non-Serious) adverse events were defined as suicidal ideation or homicidal ideation.
Arm/Group Title	PTOEND		PTOEND+PI
Arm/Group Description	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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.		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. 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. 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. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.
All Cause Mortality
	PTOEND		PTOEND+PI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Serious Adverse Events
	PTOEND		PTOEND+PI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/40 (22.5%)		7/40 (17.5%)
General disorders
Hospitalization for multiple causes	2/40 (5%)		0/40 (0%)
Infections and infestations
Hospitalization for infection/abscess	2/40 (5%)		1/40 (2.5%)
Musculoskeletal and connective tissue disorders
Hospitalization for musculoskeletal problem / injury	0/40 (0%)		3/40 (7.5%)
Nervous system disorders
Hospitalization for nervous system disorder	1/40 (2.5%)		1/40 (2.5%)
Pregnancy, puerperium and perinatal conditions
Congenital Anomaly or Birth Defect	1/40 (2.5%)		0/40 (0%)
Hospitalization related to pregnancy	2/40 (5%)		1/40 (2.5%)
Psychiatric disorders
Suicide Attempt	0/40 (0%)		1/40 (2.5%)
Hospitalization for psychiatric problem	2/40 (5%)		0/40 (0%)
Renal and urinary disorders
Hospitalization for renal disorder	0/40 (0%)		1/40 (2.5%)
Respiratory, thoracic and mediastinal disorders
Hospitalization for respiratory condition	1/40 (2.5%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	PTOEND		PTOEND+PI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.