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Trial Outcomes & Findings for SafetyNet Program for Opioid Use Disorder (OUD) (NCT NCT04253782)

NCT ID: NCT04253782

Last Updated: 2024-10-18

Results Overview

Count of positive urine tests at 30 days after intervention per patient (data obtained via chart review)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

30 days post intervention

Results posted on

2024-10-18

Participant Flow

Due to COVID interruptions investigators only looked at the total number of patients that enrolled in the study which was 81, then compared differences between those who were successfully followed up and those who were not. (This was only among individuals who enrolled in the study.) There were no comparisons made to historic controls or to patients who accepted BUP in the ED during that time period.

Participant milestones

Participant milestones
Measure
SafetyNet Without Successful Follow Ups
Participants that received SafetyNet and had unsuccessful follow-ups.
SafetyNet With Successful Follow Ups
Participants that received SafetyNet and had successful follow-ups.
Overall Study
STARTED
36
45
Overall Study
COMPLETED
34
45
Overall Study
NOT COMPLETED
2
0

Reasons for withdrawal

Reasons for withdrawal
Measure
SafetyNet Without Successful Follow Ups
Participants that received SafetyNet and had unsuccessful follow-ups.
SafetyNet With Successful Follow Ups
Participants that received SafetyNet and had successful follow-ups.
Overall Study
Death
2
0

Baseline Characteristics

SafetyNet Program for Opioid Use Disorder (OUD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SafetyNet Without Successful Follow Ups
n=36 Participants
Participants that received SafetyNet and had unsuccessful follow-ups.
SafetyNet With Successful Follow Ups
n=45 Participants
Participants that received SafetyNet and had successful follow-ups.
Total
n=81 Participants
Total of all reporting groups
Age, Continuous
37.50 years
STANDARD_DEVIATION 10.49 • n=5 Participants
41.62 years
STANDARD_DEVIATION 11.15 • n=7 Participants
39.79 years
STANDARD_DEVIATION 10.99 • n=5 Participants
Sex/Gender, Customized
Gender · Male
21 Participants
n=5 Participants
34 Participants
n=7 Participants
55 Participants
n=5 Participants
Sex/Gender, Customized
Gender · Female
14 Participants
n=5 Participants
11 Participants
n=7 Participants
25 Participants
n=5 Participants
Sex/Gender, Customized
Gender · Other
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Black
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · White
20 Participants
n=5 Participants
23 Participants
n=7 Participants
43 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
6 Participants
n=5 Participants
11 Participants
n=7 Participants
17 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Other/Unlisted
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United States
36 participants
n=5 Participants
45 participants
n=7 Participants
81 participants
n=5 Participants
Insurance
Private
3 Participants
n=5 Participants
4 Participants
n=7 Participants
7 Participants
n=5 Participants
Insurance
Medicare
2 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
Insurance
Medicaid
30 Participants
n=5 Participants
36 Participants
n=7 Participants
66 Participants
n=5 Participants
Insurance
None
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 30 days post intervention

Count of positive urine tests at 30 days after intervention per patient (data obtained via chart review)

Outcome measures

Outcome measures
Measure
SafetyNet Without Successful Follow Ups
n=36 Participants
Participants that received SafetyNet and had unsuccessful follow-ups.
SafetyNet With Successful Follow Ups
n=45 Participants
Participants that received SafetyNet and had successful follow-ups.
Frequency of Positive Urine Tests at 30 Days (Chart Review)
3 positive tests
1 Participants
0 Participants
Frequency of Positive Urine Tests at 30 Days (Chart Review)
0 positive tests
35 Participants
45 Participants

PRIMARY outcome

Timeframe: 180 days post intervention

Count of positive urine tests at 180 days after intervention per patient (data obtained via chart review)

Outcome measures

Outcome measures
Measure
SafetyNet Without Successful Follow Ups
n=36 Participants
Participants that received SafetyNet and had unsuccessful follow-ups.
SafetyNet With Successful Follow Ups
n=45 Participants
Participants that received SafetyNet and had successful follow-ups.
Frequency of Positive Urine Tests at 180 Days (Chart Review)
0 positive tests
31 Participants
42 Participants
Frequency of Positive Urine Tests at 180 Days (Chart Review)
1 positive test
2 Participants
3 Participants
Frequency of Positive Urine Tests at 180 Days (Chart Review)
2 positive tests
1 Participants
0 Participants
Frequency of Positive Urine Tests at 180 Days (Chart Review)
3 positive tests
1 Participants
0 Participants
Frequency of Positive Urine Tests at 180 Days (Chart Review)
4 positive tests
1 Participants
0 Participants

PRIMARY outcome

Timeframe: 30 days post intervention

Count of Emergency Department Overdose(s) at 30 days after intervention per patient (data obtained via chart review)

Outcome measures

Outcome measures
Measure
SafetyNet Without Successful Follow Ups
n=36 Participants
Participants that received SafetyNet and had unsuccessful follow-ups.
SafetyNet With Successful Follow Ups
n=45 Participants
Participants that received SafetyNet and had successful follow-ups.
Frequency of Emergency Department Overdose(s) at 30 Days (Chart Review)
0 overdoses
32 Participants
39 Participants
Frequency of Emergency Department Overdose(s) at 30 Days (Chart Review)
1 overdose
2 Participants
3 Participants
Frequency of Emergency Department Overdose(s) at 30 Days (Chart Review)
2 overdoses
2 Participants
2 Participants
Frequency of Emergency Department Overdose(s) at 30 Days (Chart Review)
3 overdoses
0 Participants
1 Participants

PRIMARY outcome

Timeframe: 180 days post intervention

Count of Emergency Department Overdose(s) at 180 days after intervention per patient (data obtained via chart review)

Outcome measures

Outcome measures
Measure
SafetyNet Without Successful Follow Ups
n=36 Participants
Participants that received SafetyNet and had unsuccessful follow-ups.
SafetyNet With Successful Follow Ups
n=45 Participants
Participants that received SafetyNet and had successful follow-ups.
Frequency of Emergency Department Overdose(s) at 180 Days (Chart Review)
2 overdoses
0 Participants
4 Participants
Frequency of Emergency Department Overdose(s) at 180 Days (Chart Review)
5 overdoses
1 Participants
0 Participants
Frequency of Emergency Department Overdose(s) at 180 Days (Chart Review)
0 overdoses
27 Participants
34 Participants
Frequency of Emergency Department Overdose(s) at 180 Days (Chart Review)
1 overdose
5 Participants
4 Participants
Frequency of Emergency Department Overdose(s) at 180 Days (Chart Review)
3 overdoses
2 Participants
1 Participants
Frequency of Emergency Department Overdose(s) at 180 Days (Chart Review)
4 overdoses
1 Participants
0 Participants
Frequency of Emergency Department Overdose(s) at 180 Days (Chart Review)
6 overdoses
0 Participants
1 Participants
Frequency of Emergency Department Overdose(s) at 180 Days (Chart Review)
9 overdoses
0 Participants
1 Participants

PRIMARY outcome

Timeframe: 180 days post intervention

Percentage of patients engaged in Medication Assisted Therapy (MAT) within 180 days after intervention (data obtained via chart review)

Outcome measures

Outcome measures
Measure
SafetyNet Without Successful Follow Ups
n=36 Participants
Participants that received SafetyNet and had unsuccessful follow-ups.
SafetyNet With Successful Follow Ups
n=45 Participants
Participants that received SafetyNet and had successful follow-ups.
Percentage of Patients Engaged in Medication Assisted Therapy (MAT) Within 180 Days (Chart Review)
23 Participants
32 Participants

PRIMARY outcome

Timeframe: 180 days post intervention

Percentage of patients with any use of Suboxone within 180 days after intervention (data obtained via chart review)

Outcome measures

Outcome measures
Measure
SafetyNet Without Successful Follow Ups
n=36 Participants
Participants that received SafetyNet and had unsuccessful follow-ups.
SafetyNet With Successful Follow Ups
n=45 Participants
Participants that received SafetyNet and had successful follow-ups.
Percentage of Patients With Any Use of Suboxone Within 180 Days (Chart Review)
10 Participants
19 Participants

PRIMARY outcome

Timeframe: 30 days post intervention

Population: Patient self-report data was not collected due to logistical challenges including COVID-19.

Frequency of positive urine tests within 30 days after intervention (data obtained via self-report)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 180 days post intervention

Population: Patient self-report data was not collected due to logistical challenges including COVID-19.

Frequency of positive urine tests within 180 days after intervention (data obtained via self-report)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days post intervention

Percentage of patients with at least 1 positive urine test at 30 days after intervention (data obtained via chart review)

Outcome measures

Outcome measures
Measure
SafetyNet Without Successful Follow Ups
n=36 Participants
Participants that received SafetyNet and had unsuccessful follow-ups.
SafetyNet With Successful Follow Ups
n=45 Participants
Participants that received SafetyNet and had successful follow-ups.
Percentage of Positive Urine Tests at 30 Days (Chart Review)
1 Participants
0 Participants

SECONDARY outcome

Timeframe: 180 days post intervention

Percentage of patients with at least 1 positive urine test at 180 days after intervention (data obtained via chart review)

Outcome measures

Outcome measures
Measure
SafetyNet Without Successful Follow Ups
n=36 Participants
Participants that received SafetyNet and had unsuccessful follow-ups.
SafetyNet With Successful Follow Ups
n=45 Participants
Participants that received SafetyNet and had successful follow-ups.
Percentage of Positive Urine Tests at 180 Days (Chart Review)
5 Participants
3 Participants

SECONDARY outcome

Timeframe: 30 days post intervention

Population: Patient self-report data was not collected due to logistical challenges including COVID-19.

Percentage of positive urine tests within 30 days after intervention (data obtained via chart review)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 180 days post intervention

Population: Patient self-report data was not collected due to logistical challenges including COVID-19.

Percentage of positive urine tests within 180 days after intervention (data obtained via self-report)

Outcome measures

Outcome data not reported

Adverse Events

SafetyNet Without Successful Follow Ups

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

SafetyNet With Successful Follow Ups

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Joseph, MD

Yale School of Medicine

Phone: (203) 785-4404

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place