Trial Outcomes & Findings for A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses (NCT NCT02922959)
NCT ID: NCT02922959
Last Updated: 2020-06-24
Results Overview
whether or not participant enrolled in medication-assisted treatment within the follow-up period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
12 months
Results posted on
2020-06-24
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
3 Weeks
|
38
|
36
|
|
Overall Study
3 Months
|
35
|
31
|
|
Overall Study
6 Months
|
28
|
30
|
|
Overall Study
12 Months
|
21
|
23
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
19
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
Baseline characteristics by cohort
| Measure |
PTOEND
n=40 Participants
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
n=40 Participants
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
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
39.1 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthswhether or not participant enrolled in medication-assisted treatment within the follow-up period
Outcome measures
| Measure |
PTOEND
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Medication-Assisted Treatment Enrollment
|
7 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 monthswhether or not participant experienced an opioid overdose within the follow-up period period.
Outcome measures
| Measure |
PTOEND
n=40 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Opioid Overdose Experience
|
13 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at 12-month visitPopulation: Analysis could only be done on data provided by participants who attended the 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.
Outcome measures
| Measure |
PTOEND
n=21 Participants
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
n=23 Participants
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.
|
|---|---|---|
|
Change in Opioid Use (Timeline Follow-back)
|
-10.2 days
Standard Deviation 12.7
|
-8.7 days
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: at 12-month visitPopulation: Analysis could only be done on samples provided by participants who attended the 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.
Outcome measures
| Measure |
PTOEND
n=21 Participants
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
n=23 Participants
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.
|
|---|---|---|
|
Change in Opioid Use (Urine Drug Screen)
|
18 Participants
|
20 Participants
|
Adverse Events
PTOEND
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
PTOEND+PI
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PTOEND
n=40 participants at risk
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
n=40 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hospitalization for musculoskeletal problem / injury
|
0.00%
0/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
7.5%
3/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
2.5%
1/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Congenital Anomaly or Birth Defect
|
2.5%
1/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
0.00%
0/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
|
Nervous system disorders
Hospitalization for nervous system disorder
|
2.5%
1/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
2.5%
1/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
|
Renal and urinary disorders
Hospitalization for renal disorder
|
0.00%
0/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
2.5%
1/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization related to pregnancy
|
5.0%
2/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
2.5%
1/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
|
Infections and infestations
Hospitalization for infection/abscess
|
5.0%
2/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
2.5%
1/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
|
Psychiatric disorders
Hospitalization for psychiatric problem
|
5.0%
2/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
0.00%
0/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for respiratory condition
|
2.5%
1/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
0.00%
0/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
|
General disorders
Hospitalization for multiple causes
|
5.0%
2/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
0.00%
0/40 • 12 months. Adverse events were systematically assessed during each research visit.
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Theresa Winhusen
University of Cincinnati Addiction Sciences Division
Phone: 5135858292
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place