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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Use Disorder Patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment As Usual | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Days of Opioid Use | Days of use during the first 4 weeks post discharge | Up to Week 4 Post Discharge |
| Positive Urine Drug Screen (UDS) at Week 1 | Number of positive UDSs at Week 1 | week 1 |
| Negative UDSs at Week 1 | Number of negative UDSs at Week 1 | week 1 |
| Missing UDSs at Week 1 | Number of missing UDSs at Week 1 | week 1 |
| Missing UDSs at Week 4 | Number of missing UDSs at Week 4 | week 4 |
| Positive UDSs at Week 4 | Number of positive UDSs at Week 4 | week 4 |
| Negative UDSs at Week 4 | Number of negative UDSs at Week 4 | week 4 |
| Missing UDSs at Week 8 | Number of missing UDSs at Week 8 | week 8 |
| Negative UDSs at Week 8 | Number of negative UDSs at Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| John Rotrosen, MD | New York University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tarzana Treatment Centers | Tarzana | California | 91356 | United States | ||
| Gateway Community Services, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment As Usual | Patients admitted to detoxification or short term residential programs associated with CTN-0051 for Opioid Use Disorder (OUD). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2016 | Feb 21, 2020 |
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| week 8 |
| Positive UDSs at Week 8 | Number of positive UDSs at Week 8 | week 8 |
| Time to First Use | Days to first opioid use from Timeline Followback | Up to Week 8 Post Discharge |
| Time to Regular Use | Days to regular opioid use from Timeline Followback | Up to Week 8 Post Discharge |
| Days of Opioid Use | Days of use up 8 weeks post discharge | Up to Week 8 Post Discharge |
| Jacksonville |
| Florida |
| 32201 |
| United States |
| Stanley Street Treatment and Resources | Fall River | Massachusetts | 02720 | United States |
| Bellevue Hospital | New York | New York | 10016 | United States |
| Maryhaven | Columbus | Ohio | 43207 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment As Usual | Patients admitted to detoxification or short term residential programs associated with CTN-0051 with OUD. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Opioid Severity | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Days of Opioid Use | Days of use during the first 4 weeks post discharge | Posted | Mean | Standard Deviation | days | Up to Week 4 Post Discharge |
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| Primary | Positive Urine Drug Screen (UDS) at Week 1 | Number of positive UDSs at Week 1 | Posted | Count of Participants | Participants | week 1 |
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| Primary | Negative UDSs at Week 1 | Number of negative UDSs at Week 1 | Posted | Count of Participants | Participants | week 1 |
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| Primary | Missing UDSs at Week 1 | Number of missing UDSs at Week 1 | Posted | Count of Participants | Participants | week 1 |
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| Primary | Missing UDSs at Week 4 | Number of missing UDSs at Week 4 | Posted | Count of Participants | Participants | week 4 |
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| Primary | Positive UDSs at Week 4 | Number of positive UDSs at Week 4 | Posted | Count of Participants | Participants | week 4 |
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| Primary | Negative UDSs at Week 4 | Number of negative UDSs at Week 4 | Posted | Count of Participants | Participants | week 4 |
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| Primary | Missing UDSs at Week 8 | Number of missing UDSs at Week 8 | Posted | Count of Participants | Participants | week 8 |
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| Primary | Negative UDSs at Week 8 | Number of negative UDSs at Week 8 | Posted | Count of Participants | Participants | week 8 |
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| Primary | Positive UDSs at Week 8 | Number of positive UDSs at Week 8 | Posted | Count of Participants | Participants | week 8 |
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| Primary | Time to First Use | Days to first opioid use from Timeline Followback | Patients admitted to detoxification or short term residential programs associated with CTN-0051 for OUD | Posted | Mean | Standard Deviation | days | Up to Week 8 Post Discharge |
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| Primary | Time to Regular Use | Days to regular opioid use from Timeline Followback | Patients admitted to detoxification or short term residential programs associated with CTN-0051 for OUD | Posted | Mean | Standard Deviation | days | Up to Week 8 Post Discharge |
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| Primary | Days of Opioid Use | Days of use up 8 weeks post discharge | Posted | Mean | Standard Deviation | days | Up to Week 8 Post Discharge |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment As Usual | Patients who were admitted to detoxification or short term residential programs associated with CTN-0051 with OUD. | 1 | 211 | 7 | 211 | 8 | 211 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Rotrosen | NYU Grossman School of Medicine | 646-754-4763 | john.rotrosen@nyulangone.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2017 | Feb 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 35 - <45 |
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| 45 - <55 |
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| 55 - <65 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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