Trial Outcomes & Findings for Start Treatment and Recovery for Opioid Use Disorder (NCT NCT04505540)
NCT ID: NCT04505540
Last Updated: 2023-12-11
Results Overview
Self-reported enrollment in treatment for opioid use disorder after 1 week
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
1 week
Results posted on
2023-12-11
Participant Flow
Participant milestones
| Measure |
Bridge Clinic
Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Bridge Clinic: Specialized addiction bridge clinic
|
|---|---|
|
Baseline
STARTED
|
104
|
|
Baseline
COMPLETED
|
94
|
|
Baseline
NOT COMPLETED
|
10
|
|
1 Week Eligible to Self-report
STARTED
|
94
|
|
1 Week Eligible to Self-report
COMPLETED
|
93
|
|
1 Week Eligible to Self-report
NOT COMPLETED
|
1
|
|
1 Week Contacted for Self-report
STARTED
|
93
|
|
1 Week Contacted for Self-report
COMPLETED
|
66
|
|
1 Week Contacted for Self-report
NOT COMPLETED
|
27
|
|
1 Week Eligible for Urinanalysis
STARTED
|
94
|
|
1 Week Eligible for Urinanalysis
COMPLETED
|
41
|
|
1 Week Eligible for Urinanalysis
NOT COMPLETED
|
53
|
|
1 Week Urine Sample Provided
STARTED
|
41
|
|
1 Week Urine Sample Provided
COMPLETED
|
28
|
|
1 Week Urine Sample Provided
NOT COMPLETED
|
13
|
|
3 Months Eligible to Self-report
STARTED
|
94
|
|
3 Months Eligible to Self-report
COMPLETED
|
87
|
|
3 Months Eligible to Self-report
NOT COMPLETED
|
7
|
|
3 Months Contacted for Self-report
STARTED
|
87
|
|
3 Months Contacted for Self-report
COMPLETED
|
65
|
|
3 Months Contacted for Self-report
NOT COMPLETED
|
22
|
|
3 Months Eligible for Urinanalysis
STARTED
|
94
|
|
3 Months Eligible for Urinanalysis
COMPLETED
|
24
|
|
3 Months Eligible for Urinanalysis
NOT COMPLETED
|
70
|
|
3 Months Urine Sample Provided
STARTED
|
24
|
|
3 Months Urine Sample Provided
COMPLETED
|
11
|
|
3 Months Urine Sample Provided
NOT COMPLETED
|
13
|
|
6 Months Eligible to Self-report
STARTED
|
94
|
|
6 Months Eligible to Self-report
COMPLETED
|
85
|
|
6 Months Eligible to Self-report
NOT COMPLETED
|
9
|
|
6 Months Contacted for Self-report
STARTED
|
85
|
|
6 Months Contacted for Self-report
COMPLETED
|
68
|
|
6 Months Contacted for Self-report
NOT COMPLETED
|
17
|
|
6 Months Eligible for Urinanalysis
STARTED
|
94
|
|
6 Months Eligible for Urinanalysis
COMPLETED
|
3
|
|
6 Months Eligible for Urinanalysis
NOT COMPLETED
|
91
|
|
6 Months Urine Sample Provided
STARTED
|
3
|
|
6 Months Urine Sample Provided
COMPLETED
|
3
|
|
6 Months Urine Sample Provided
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Bridge Clinic
Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Bridge Clinic: Specialized addiction bridge clinic
|
|---|---|
|
Baseline
Protocol Violation
|
10
|
|
1 Week Eligible to Self-report
Incarcerated/Institutionalized
|
1
|
|
1 Week Contacted for Self-report
Lost to Follow-up
|
27
|
|
1 Week Eligible for Urinanalysis
COVID disruption of urine sampling
|
52
|
|
1 Week Eligible for Urinanalysis
Incarcerated/Institutionalized
|
1
|
|
1 Week Urine Sample Provided
Lost to Follow-up
|
13
|
|
3 Months Eligible to Self-report
Incarcerated/Institutionalized
|
7
|
|
3 Months Contacted for Self-report
Lost to Follow-up
|
22
|
|
3 Months Eligible for Urinanalysis
COVID disruption of urine sampling
|
70
|
|
3 Months Urine Sample Provided
Lost to Follow-up
|
13
|
|
6 Months Eligible to Self-report
Incarcerated/Institutionalized
|
9
|
|
6 Months Contacted for Self-report
Lost to Follow-up
|
17
|
|
6 Months Eligible for Urinanalysis
COVID disruption of urine sampling
|
91
|
Baseline Characteristics
Start Treatment and Recovery for Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Bridge Clinic
n=94 Participants
Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Bridge Clinic: Specialized addiction bridge clinic
|
|---|---|
|
Age, Continuous
|
33.6 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex/Gender, Customized
Male/Female/Unknown · Male
|
60 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male/Female/Unknown · Female
|
33 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male/Female/Unknown · Unknown
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekSelf-reported enrollment in treatment for opioid use disorder after 1 week
Outcome measures
| Measure |
Bridge Clinic
n=93 Participants
Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Bridge Clinic: Specialized addiction bridge clinic
|
|---|---|
|
Number of Participants With Self-reported Treatment Retention
|
51 Participants
|
PRIMARY outcome
Timeframe: 3 monthsSelf-reported enrollment in treatment for opioid use disorder after 3 months
Outcome measures
| Measure |
Bridge Clinic
n=87 Participants
Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Bridge Clinic: Specialized addiction bridge clinic
|
|---|---|
|
Number of Participants With Self-reported Treatment Retention
|
49 Participants
|
PRIMARY outcome
Timeframe: 6 monthsSelf-reported enrollment in treatment for opioid use disorder after 6 months
Outcome measures
| Measure |
Bridge Clinic
n=85 Participants
Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Bridge Clinic: Specialized addiction bridge clinic
|
|---|---|
|
Number of Participants With Self-reported Treatment Retention
|
51 Participants
|
SECONDARY outcome
Timeframe: 1 weekUrine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit.
Outcome measures
| Measure |
Bridge Clinic
n=41 Participants
Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Bridge Clinic: Specialized addiction bridge clinic
|
|---|---|
|
Number of Participants With Illicit Opioid Use
|
20 Participants
|
SECONDARY outcome
Timeframe: 3 monthsUrine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit.
Outcome measures
| Measure |
Bridge Clinic
n=24 Participants
Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Bridge Clinic: Specialized addiction bridge clinic
|
|---|---|
|
Number of Participants With Illicit Opioid Use
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 monthsUrine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit.
Outcome measures
| Measure |
Bridge Clinic
n=3 Participants
Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Bridge Clinic: Specialized addiction bridge clinic
|
|---|---|
|
Number of Participants With Illicit Opioid Use
|
1 Participants
|
Adverse Events
Bridge Clinic
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place