Trial Outcomes & Findings for TAU Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With CTN-0051 (NCT NCT02730403)

NCT ID: NCT02730403

Last Updated: 2020-03-27

Results Overview

Days of use during the first 4 weeks post discharge

• Recruitment status: COMPLETED
• Target enrollment: 211 participants
• Primary outcome timeframe: Up to Week 4 Post Discharge
• Results posted on: 2020-03-27

Participant Flow

Participant milestones

Measure	Treatment As Usual Patients admitted to detoxification or short term residential programs associated with CTN-0051 for Opioid Use Disorder (OUD).
Overall Study STARTED	211
Overall Study COMPLETED	157
Overall Study NOT COMPLETED	54

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TAU Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With CTN-0051

Baseline characteristics by cohort

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential programs associated with CTN-0051 with OUD.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	211 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35 years STANDARD_DEVIATION 9.48 • n=5 Participants
Age, Customized 18 - <25	23 Participants n=5 Participants
Age, Customized 25 - <35	96 Participants n=5 Participants
Age, Customized 35 - <45	52 Participants n=5 Participants
Age, Customized 45 - <55	33 Participants n=5 Participants
Age, Customized 55 - <65	7 Participants n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	156 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Race · Asian	1 Participants n=5 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Race · Black or African American	28 Participants n=5 Participants
Race (NIH/OMB) Race · White	143 Participants n=5 Participants
Race (NIH/OMB) Race · More than one race	10 Participants n=5 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	24 Participants n=5 Participants
Region of Enrollment United States	211 participants n=5 Participants
Baseline Opioid Severity Low	110 Participants n=5 Participants
Baseline Opioid Severity High	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 4 Post Discharge

Days of use during the first 4 weeks post discharge

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Days of Opioid Use	6.8 days Standard Deviation 8.95

PRIMARY outcome

Timeframe: week 1

Number of positive UDSs at Week 1

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Positive Urine Drug Screen (UDS) at Week 1	106 Participants

PRIMARY outcome

Timeframe: week 1

Number of negative UDSs at Week 1

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Negative UDSs at Week 1	60 Participants

PRIMARY outcome

Timeframe: week 1

Number of missing UDSs at Week 1

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Missing UDSs at Week 1	45 Participants

PRIMARY outcome

Timeframe: week 4

Number of missing UDSs at Week 4

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Missing UDSs at Week 4	54 Participants

PRIMARY outcome

Timeframe: week 4

Number of positive UDSs at Week 4

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Positive UDSs at Week 4	102 Participants

PRIMARY outcome

Timeframe: week 4

Number of negative UDSs at Week 4

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Negative UDSs at Week 4	55 Participants

PRIMARY outcome

Timeframe: week 8

Number of missing UDSs at Week 8

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Missing UDSs at Week 8	55 Participants

PRIMARY outcome

Timeframe: week 8

Number of negative UDSs at Week 8

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Negative UDSs at Week 8	66 Participants

PRIMARY outcome

Timeframe: week 8

Number of positive UDSs at Week 8

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Positive UDSs at Week 8	90 Participants

PRIMARY outcome

Timeframe: Up to Week 8 Post Discharge

Population: Patients admitted to detoxification or short term residential programs associated with CTN-0051 for OUD

Days to first opioid use from Timeline Followback

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Time to First Use	7.5 days Standard Deviation 10.17

PRIMARY outcome

Timeframe: Up to Week 8 Post Discharge

Population: Patients admitted to detoxification or short term residential programs associated with CTN-0051 for OUD

Days to regular opioid use from Timeline Followback

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Time to Regular Use	11.3 days Standard Deviation 11.58

PRIMARY outcome

Timeframe: Up to Week 8 Post Discharge

Days of use up 8 weeks post discharge

Outcome measures

Measure	Treatment As Usual n=211 Participants Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Days of Opioid Use	13.2 days Standard Deviation 16.7

Adverse Events

Treatment As Usual

Serious events: 7 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Measure	Treatment As Usual n=211 participants at risk Patients who were admitted to detoxification or short term residential programs associated with CTN-0051 with OUD.
Respiratory, thoracic and mediastinal disorders Overdose	3.3% 7/211 • Number of events 7 • 9 month For purposes of this study, only overdoses (whether hospitalized or not) and all deaths were collected. The relationship of adverse event was only collected for overdose events.

Other adverse events

Measure	Treatment As Usual n=211 participants at risk Patients who were admitted to detoxification or short term residential programs associated with CTN-0051 with OUD.
Respiratory, thoracic and mediastinal disorders Overdose	3.8% 8/211 • Number of events 12 • 9 month For purposes of this study, only overdoses (whether hospitalized or not) and all deaths were collected. The relationship of adverse event was only collected for overdose events.

Additional Information

John Rotrosen

NYU Grossman School of Medicine

Phone: 646-754-4763

Email: john.rotrosen@nyulangone.org

Results disclosure agreements

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