NCT02730403

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

Completed Results posted Last updated 27 March 2020

What this trial tests

trial testing Treatment As Usual in Opioid Use Disorder in 211 participants. Completed in 30 January 2017.

Timeline

1 June 2016

Primary endpoint
30 January 2017

30 January 2017

Quick facts

Lead sponsor	NYU Langone Health
Status	Completed
Study type	OBSERVATIONAL
Enrollment	211
Start date	1 June 2016
Primary completion	30 January 2017
Estimated completion	30 January 2017
Sites	5 locations across United States

Drugs / interventions tested

• Treatment As Usual

Conditions studied

• Opioid Use Disorder — all drugs for Opioid Use Disorder →

Sponsor

NYU Langone Health — full company profile →

Who can join

18 and older, any sex, with Opioid Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Days of Opioid Use Primary · Up to Week 4 Post Discharge

Days of use during the first 4 weeks post discharge

Group	Value	95% CI
Treatment As Usual	6.8	± 8.95

Positive Urine Drug Screen (UDS) at Week 1 Primary · week 1

Number of positive UDSs at Week 1

Group	Value	95% CI
Treatment As Usual	106

Negative UDSs at Week 1 Primary · week 1

Number of negative UDSs at Week 1

Group	Value	95% CI
Treatment As Usual	60

Missing UDSs at Week 1 Primary · week 1

Number of missing UDSs at Week 1

Group	Value	95% CI
Treatment As Usual	45

Missing UDSs at Week 4 Primary · week 4

Number of missing UDSs at Week 4

Group	Value	95% CI
Treatment As Usual	54

Positive UDSs at Week 4 Primary · week 4

Number of positive UDSs at Week 4

Group	Value	95% CI
Treatment As Usual	102

Negative UDSs at Week 4 Primary · week 4

Number of negative UDSs at Week 4

Group	Value	95% CI
Treatment As Usual	55

Missing UDSs at Week 8 Primary · week 8

Number of missing UDSs at Week 8

Group	Value	95% CI
Treatment As Usual	55

Negative UDSs at Week 8 Primary · week 8

Number of negative UDSs at Week 8

Group	Value	95% CI
Treatment As Usual	66

Positive UDSs at Week 8 Primary · week 8

Number of positive UDSs at Week 8

Group	Value	95% CI
Treatment As Usual	90

Time to First Use Primary · Up to Week 8 Post Discharge

Days to first opioid use from Timeline Followback

Group	Value	95% CI
Treatment As Usual	7.5	± 10.17

Time to Regular Use Primary · Up to Week 8 Post Discharge

Days to regular opioid use from Timeline Followback

Group	Value	95% CI
Treatment As Usual	11.3	± 11.58

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment As Usual

Serious: 7/211 (3%)

Deaths: 1/211

Serious adverse events (1 terms)

Reaction	System	Treatment As Usual
Overdose	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Treatment As Usual
Overdose	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Overdose.

Data from ClinicalTrials.gov NCT02730403 adverse events section.

Sponsor's own description

This is an observational, "ancillary study" intended to describe opioid use among opioid use disorder patients following their discharge into the community from inpatient detoxification and/or short-term residential treatment programs affiliated with parent study CTN-0051, which assessed the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.