Trial Outcomes & Findings for Rapid Initiation of Drug Treatment Engagement (NCT NCT03908437)
NCT ID: NCT03908437
Last Updated: 2024-09-03
Results Overview
Number of participants receiving treatment with medication for opioid use disorder at 1-month post-enrollment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
104 participants
Primary outcome timeframe
1-month post-enrollment
Results posted on
2024-09-03
Participant Flow
Participant milestones
| Measure |
Mobile Unit Intervention
Rapid initiation of buprenorphine/naloxone, counseling, peer support and case management from a mobile unit parked in the community
A mobile team will be led by a nurse practitioner (able to prescribe buprenorphine/naloxone in PA) and include a peer recovery specialist (PRS), and a case manager.
|
Crisis Response Center
Seeking treatment from the Crisis Response Center
The CRC mission is to evaluate, treat for up to 24 hours and refer/transfer to treatment (inpatient and outpatient)
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
49
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
31
|
25
|
Reasons for withdrawal
| Measure |
Mobile Unit Intervention
Rapid initiation of buprenorphine/naloxone, counseling, peer support and case management from a mobile unit parked in the community
A mobile team will be led by a nurse practitioner (able to prescribe buprenorphine/naloxone in PA) and include a peer recovery specialist (PRS), and a case manager.
|
Crisis Response Center
Seeking treatment from the Crisis Response Center
The CRC mission is to evaluate, treat for up to 24 hours and refer/transfer to treatment (inpatient and outpatient)
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
31
|
24
|
Baseline Characteristics
Rapid Initiation of Drug Treatment Engagement
Baseline characteristics by cohort
| Measure |
Mobile Unit Intervention
n=55 Participants
Rapid initiation of buprenorphine/naloxone, counseling, peer support and case management from a mobile unit parked in the community
A mobile team will be led by a nurse practitioner (able to prescribe buprenorphine/naloxone in PA) and include a peer recovery specialist (PRS), and a case manager.
|
Crisis Response Center
n=49 Participants
Seeking treatment from the Crisis Response Center
The CRC mission is to evaluate, treat for up to 24 hours and refer/transfer to treatment (inpatient and outpatient)
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
39.3 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
81 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
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 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
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
49 participants
n=7 Participants
|
104 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-month post-enrollmentPopulation: Analyses of participants who have completed the 1-month follow-up, n=62 (mobile unit intervention=45, Crisis Response Center n=17)
Number of participants receiving treatment with medication for opioid use disorder at 1-month post-enrollment
Outcome measures
| Measure |
Mobile Unit Intervention
n=45 Participants
Rapid initiation of buprenorphine/naloxone, counseling, peer support and case management from a mobile unit parked in the community
A mobile team will be led by a nurse practitioner (able to prescribe buprenorphine/naloxone in PA) and include a peer recovery specialist (PRS), and a case manager.
|
Crisis Response Center
n=17 Participants
Seeking treatment from the Crisis Response Center
The CRC mission is to evaluate, treat for up to 24 hours and refer/transfer to treatment (inpatient and outpatient)
|
|---|---|---|
|
Enrollment in Medication Assisted Treatment at 1-month Post-enrollment
|
33 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6-month follow-upNumber of participants who are receiving treatment with medication for opioid use disorder at 6-month post-enrollment
Outcome measures
| Measure |
Mobile Unit Intervention
n=24 Participants
Rapid initiation of buprenorphine/naloxone, counseling, peer support and case management from a mobile unit parked in the community
A mobile team will be led by a nurse practitioner (able to prescribe buprenorphine/naloxone in PA) and include a peer recovery specialist (PRS), and a case manager.
|
Crisis Response Center
n=24 Participants
Seeking treatment from the Crisis Response Center
The CRC mission is to evaluate, treat for up to 24 hours and refer/transfer to treatment (inpatient and outpatient)
|
|---|---|---|
|
Enrollment in Medication Assisted Treatment at 6-month Post-enrollment
|
15 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants who experienced fatal and non-fatal overdoses between baseline and 6-month follow-up
Outcome measures
| Measure |
Mobile Unit Intervention
n=24 Participants
Rapid initiation of buprenorphine/naloxone, counseling, peer support and case management from a mobile unit parked in the community
A mobile team will be led by a nurse practitioner (able to prescribe buprenorphine/naloxone in PA) and include a peer recovery specialist (PRS), and a case manager.
|
Crisis Response Center
n=24 Participants
Seeking treatment from the Crisis Response Center
The CRC mission is to evaluate, treat for up to 24 hours and refer/transfer to treatment (inpatient and outpatient)
|
|---|---|---|
|
Overdose During the 6-month Follow-up
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants with a positive urine drug screen and report opioid use (except treatment, e.g., methadone, buprenorphine, buprenorphine/naloxone) at 6-month follow-up
Outcome measures
| Measure |
Mobile Unit Intervention
n=24 Participants
Rapid initiation of buprenorphine/naloxone, counseling, peer support and case management from a mobile unit parked in the community
A mobile team will be led by a nurse practitioner (able to prescribe buprenorphine/naloxone in PA) and include a peer recovery specialist (PRS), and a case manager.
|
Crisis Response Center
n=24 Participants
Seeking treatment from the Crisis Response Center
The CRC mission is to evaluate, treat for up to 24 hours and refer/transfer to treatment (inpatient and outpatient)
|
|---|---|---|
|
Change in Opioid Use From Baseline to 6-month Follow-up
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Cost of 1-month intervention --- could not address this outcomePopulation: No data collected to evaluate the cost of the intervention. Because of COVID-19 and the change in intervention delivery (extended from 1month to 3 months mobile intervention and home-type delivery of intervention), we have been unable to collect data to generate the cost of the intervention.
Cost evaluation of the mobile intervention using data collected with the DATCAP (Drug Abuse Treatment Cost Analysis Program) and NMOS (Non-Medical and Other Services) -- Unable to collect data to address this outcome
Outcome measures
Outcome data not reported
Adverse Events
Mobile Unit Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Crisis Response Center
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Mobile Unit Intervention
n=55 participants at risk
Rapid initiation of buprenorphine/naloxone, counseling, peer support and case management from a mobile unit parked in the community
A mobile team will be led by a nurse practitioner (able to prescribe buprenorphine/naloxone in PA) and include a peer recovery specialist (PRS), and a case manager.
|
Crisis Response Center
n=49 participants at risk
Seeking treatment from the Crisis Response Center
The CRC mission is to evaluate, treat for up to 24 hours and refer/transfer to treatment (inpatient and outpatient)
|
|---|---|---|
|
Psychiatric disorders
death
|
0.00%
0/55 • Adverse event occurring between baseline and 6-month follow-up
Include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, and other adverse events that exceed a frequency threshold of 5%
|
2.0%
1/49 • Adverse event occurring between baseline and 6-month follow-up
Include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, and other adverse events that exceed a frequency threshold of 5%
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Metzger, Research Professor, Director of HIV Prevention Research Unit
University of Pennsylvania, Dpt of Psychiatry, Perelman School of Medicine
Phone: 215-746-7355
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place