Opioid Use DisorderNCT02730403
TAU Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With CTN-0051
An observational study of Opioid Use Disorder, run by NYU Langone Health at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Treatment As Usual
- How many people
- 211 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2016to 30 Jan 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be a convenience sample of up to three hundred sixty (360) opioid dependent patients leaving detoxification or short-term residential units at sites participating in CTN-0051. Up to 60 participants will be recruited at each of approximately six sites.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Maryhaven
Columbus, Ohio, 43207
Stanley Street Treatment and Resources
Fall River, Massachusetts, 02720
Gateway Community Services, Inc.
Jacksonville, Florida, 32201
Bellevue Hospital
New York, New York, 10016
Tarzana Treatment Centers
Tarzana, California, 91356
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Treatment As Usual
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment As UsualOther
| Study group | Role | What they receive |
|---|---|---|
| Opioid Use Disorder Patients | Not described Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Opioid Use
Days of use during the first 4 weeks post discharge
Measured: Up to Week 4 Post Discharge
Positive Urine Drug Screen (UDS) at Week 1
Number of positive UDSs at Week 1
Measured: week 1
Negative UDSs at Week 1
Number of negative UDSs at Week 1
Measured: week 1
Missing UDSs at Week 1
Number of missing UDSs at Week 1
Measured: week 1
Missing UDSs at Week 4
Number of missing UDSs at Week 4
Measured: week 4
Positive UDSs at Week 4
Number of positive UDSs at Week 4
Measured: week 4
Negative UDSs at Week 4
Number of negative UDSs at Week 4
Measured: week 4
Missing UDSs at Week 8
Number of missing UDSs at Week 8
Measured: week 8
Negative UDSs at Week 8
Number of negative UDSs at Week 8
Measured: week 8
Positive UDSs at Week 8
Number of positive UDSs at Week 8
Measured: week 8
Time to First Use
Days to first opioid use from Timeline Followback
Measured: Up to Week 8 Post Discharge
Time to Regular Use
Days to regular opioid use from Timeline Followback
Measured: Up to Week 8 Post Discharge
Days of Opioid Use
Days of use up 8 weeks post discharge
Measured: Up to Week 8 Post Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start1 Jun 2016
- Primary completion30 Jan 2017
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Rotrosen, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730403
- Sponsor's protocol ID
- 16-00090
- Status last verified
- Mar 2020
- First submitted
- 21 Mar 2016
- Last updated
- 27 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02730403
- Acronym / sponsor ID
- 16-00090
- Conditions
- Opioid Use Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Posted 18 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opioid Use Disorder Patients | – | Other: Treatment As Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be a convenience sample of up to three hundred sixty (360) opioid dependent patients leaving detoxification or short-term residential units at sites participating in CTN-0051. Up to 60 participants will be recruited at each of approximately six sites.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment As Usual | Other | Opioid Use Disorder Patients |
Primary outcome
Days of Opioid Use
Time frame: Up to Week 4 Post Discharge
Days of use during the first 4 weeks post discharge
Positive Urine Drug Screen (UDS) at Week 1
Time frame: week 1
Number of positive UDSs at Week 1
Negative UDSs at Week 1
Time frame: week 1
Number of negative UDSs at Week 1
Missing UDSs at Week 1
Time frame: week 1
Number of missing UDSs at Week 1
Missing UDSs at Week 4
Time frame: week 4
Number of missing UDSs at Week 4
Positive UDSs at Week 4
Time frame: week 4
Number of positive UDSs at Week 4
Negative UDSs at Week 4
Time frame: week 4
Number of negative UDSs at Week 4
Missing UDSs at Week 8
Time frame: week 8
Number of missing UDSs at Week 8
Negative UDSs at Week 8
Time frame: week 8
Number of negative UDSs at Week 8
Positive UDSs at Week 8
Time frame: week 8
Number of positive UDSs at Week 8
Time to First Use
Time frame: Up to Week 8 Post Discharge
Days to first opioid use from Timeline Followback
Time to Regular Use
Time frame: Up to Week 8 Post Discharge
Days to regular opioid use from Timeline Followback
Days of Opioid Use
Time frame: Up to Week 8 Post Discharge
Days of use up 8 weeks post discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Rotrosen, MD principal investigator
New York University Medical School
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder, run by NYU Langone Health at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of Opioid Use (time frame: Up to Week 4 Post Discharge). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.