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

Treatment-as-Usual (TAU) Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With National Institute on Drug Abuse (NIDA) CTN-0051

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02730403
Enrollment
211
Registered
2016-04-06
Start date
2016-06-01
Completion date
2017-01-30
Last updated
2020-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder

Brief summary

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.

Detailed description

Participant recruitment will begin after recruitment for CTN-0051 has been completed. Opioid use disorder patients will be recruited prior to leaving detoxification and/or short-term residential programs. Screening and baseline data (focused on demographics, diagnosis and service utilization) will be collected prior to discharge, and follow-up data (focused on opioid use) will be collected at weeks 1, 4 and 8 following discharge.

Interventions

OTHERTreatment As Usual

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older; * Meet DSM-5 criteria for opioid-use disorder (heroin or prescription opioids); * Have used opioids other than as specifically prescribed within thirty days prior to consent * Seeking treatment for opioid dependence; * Able to provide written informed consent; * Able to speak English sufficiently to understand the study procedures.

Exclusion criteria

* Serious medical, psychiatric or substance use disorder that, in the opinion of the Site PI, would make participation hazardous to the participant, compromise study findings or prevent the participant from completing the study; * Suicidal or homicidal ideation that requires immediate attention; * Maintenance on methadone at doses of 30mg or greater at the time of signing consent; * Presence of pain of sufficient severity as to require ongoing pain management with opioids; * Pending legal action or other reasons that might prevent an individual from completing the study; * If female, currently pregnant or breastfeeding or planning on conception; * Prior participation in parent trial CTN-0051

Design outcomes

Primary

MeasureTime frameDescription
Days of Opioid UseUp to Week 4 Post DischargeDays of use during the first 4 weeks post discharge
Positive Urine Drug Screen (UDS) at Week 1week 1Number of positive UDSs at Week 1
Negative UDSs at Week 1week 1Number of negative UDSs at Week 1
Missing UDSs at Week 1week 1Number of missing UDSs at Week 1
Missing UDSs at Week 4week 4Number of missing UDSs at Week 4
Positive UDSs at Week 4week 4Number of positive UDSs at Week 4
Negative UDSs at Week 4week 4Number of negative UDSs at Week 4
Missing UDSs at Week 8week 8Number of missing UDSs at Week 8
Negative UDSs at Week 8week 8Number of negative UDSs at Week 8
Positive UDSs at Week 8week 8Number of positive UDSs at Week 8
Time to First UseUp to Week 8 Post DischargeDays to first opioid use from Timeline Followback
Time to Regular UseUp to Week 8 Post DischargeDays to regular opioid use from Timeline Followback

Countries

United States

Participant flow

Participants by arm

ArmCount
Treatment As Usual
Patients admitted to detoxification or short term residential programs associated with CTN-0051 with OUD.
211
Total211

Baseline characteristics

CharacteristicTreatment As Usual
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
211 Participants
Age, Continuous35 years
STANDARD_DEVIATION 9.48
Age, Customized
18 - <25
23 Participants
Age, Customized
25 - <35
96 Participants
Age, Customized
35 - <45
52 Participants
Age, Customized
45 - <55
33 Participants
Age, Customized
55 - <65
7 Participants
Baseline Opioid Severity
High
101 Participants
Baseline Opioid Severity
Low
110 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
37 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
172 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
Race
American Indian or Alaska Native
4 Participants
Race (NIH/OMB)
Race
Asian
1 Participants
Race (NIH/OMB)
Race
Black or African American
28 Participants
Race (NIH/OMB)
Race
More than one race
10 Participants
Race (NIH/OMB)
Race
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Race
Unknown or Not Reported
24 Participants
Race (NIH/OMB)
Race
White
143 Participants
Region of Enrollment
United States
211 participants
Sex: Female, Male
Female
55 Participants
Sex: Female, Male
Male
156 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
1 / 211
other
Total, other adverse events
8 / 211
serious
Total, serious adverse events
7 / 211

Outcome results

Primary

Days of Opioid Use

Days of use during the first 4 weeks post discharge

Time frame: Up to Week 4 Post Discharge

ArmMeasureValue (MEAN)Dispersion
Treatment As UsualDays of Opioid Use6.8 daysStandard Deviation 8.95
Primary

Days of Opioid Use

Days of use up 8 weeks post discharge

Time frame: Up to Week 8 Post Discharge

ArmMeasureValue (MEAN)Dispersion
Treatment As UsualDays of Opioid Use13.2 daysStandard Deviation 16.7
Primary

Missing UDSs at Week 1

Number of missing UDSs at Week 1

Time frame: week 1

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment As UsualMissing UDSs at Week 145 Participants
Primary

Missing UDSs at Week 4

Number of missing UDSs at Week 4

Time frame: week 4

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment As UsualMissing UDSs at Week 454 Participants
Primary

Missing UDSs at Week 8

Number of missing UDSs at Week 8

Time frame: week 8

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment As UsualMissing UDSs at Week 855 Participants
Primary

Negative UDSs at Week 1

Number of negative UDSs at Week 1

Time frame: week 1

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment As UsualNegative UDSs at Week 160 Participants
Primary

Negative UDSs at Week 4

Number of negative UDSs at Week 4

Time frame: week 4

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment As UsualNegative UDSs at Week 455 Participants
Primary

Negative UDSs at Week 8

Number of negative UDSs at Week 8

Time frame: week 8

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment As UsualNegative UDSs at Week 866 Participants
Primary

Positive UDSs at Week 4

Number of positive UDSs at Week 4

Time frame: week 4

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment As UsualPositive UDSs at Week 4102 Participants
Primary

Positive UDSs at Week 8

Number of positive UDSs at Week 8

Time frame: week 8

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment As UsualPositive UDSs at Week 890 Participants
Primary

Positive Urine Drug Screen (UDS) at Week 1

Number of positive UDSs at Week 1

Time frame: week 1

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment As UsualPositive Urine Drug Screen (UDS) at Week 1106 Participants
Primary

Time to First Use

Days to first opioid use from Timeline Followback

Time frame: Up to Week 8 Post Discharge

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

ArmMeasureValue (MEAN)Dispersion
Treatment As UsualTime to First Use7.5 daysStandard Deviation 10.17
Primary

Time to Regular Use

Days to regular opioid use from Timeline Followback

Time frame: Up to Week 8 Post Discharge

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

ArmMeasureValue (MEAN)Dispersion
Treatment As UsualTime to Regular Use11.3 daysStandard Deviation 11.58

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026