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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA042243 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study is an open--label randomized outpatient trial to evaluate feasibility and efficacy of rapid buprenorphine (BUP) discontinuation followed by brief course of treatment with long--acting naltrexone (XR--NTX) and to compare it to the standard method of gradual BUP taper.Individuals with opioid use disorder (OUD) (N=60) who have successfully completed at least 6 months of buprenorphine treatment and do not wish to remain in a long--term buprenorphine maintenance program will be recruited. The first phase includes a 4--week period of stabilization on buprenorphine 4--8 mg at the research clinic to assure that patients are stable, compliant, and free from illicit opioids. Participants that meet the above criteria will be randomized 1:1 to: 1) buprenorphine discontinuation and outpatient transition to XR--NTX with 3 monthly injections, or 2) buprenorphine discontinuation using a gradual 5-week long taper. In both groups participants will receive weekly relapse prevention therapy and will be monitored for the duration of the trial, which is 25 weeks post randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen 1 | Experimental | Rapid Monday to Friday oral naltrexone-induction procedure |
|
| Regimen 2 | Experimental | 5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivitrol | Drug | Oral naltrexone induction procedure followed by Vivitrol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Successfully Transitioned Off Buprenorphine | Percent of patients retained in treatment and abstinent from opioids at the end of the trial | Week 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Regimen 1 | Rapid Monday to Friday oral naltrexone-induction procedure Vivitrol: Oral naltrexone induction procedure followed by Vivitrol |
| FG001 | Regimen 2 | 5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg Buprenorphine: 5-week buprenorphine taper |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Regimen 1 | Rapid Monday to Friday oral naltrexone-induction procedure Vivitrol: Oral naltrexone induction procedure followed by Vivitrol |
| BG001 | Regimen 2 | 5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg Buprenorphine: 5-week buprenorphine taper |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent of Patients Successfully Transitioned Off Buprenorphine | Percent of patients retained in treatment and abstinent from opioids at the end of the trial | Participants who were randomized to one of the two study regimens | Posted | Count of Participants | Participants | Week 25 |
|
7 months
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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 | Regimen 1 | Rapid Monday to Friday oral naltrexone-induction procedure Vivitrol: Oral naltrexone induction procedure followed by Vivitrol |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization for pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Participant had difficulty breathing, chest congestion, runny nose, and decreased energy. The participant was admitted to the hospital, and he was diagnosed with pneumonia. Participant was treated with IV antibiotics and fully recovered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Bisaga | NYS Psychiatric Institute | 646-774-6155 | adam.bisaga@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Apr 2, 2019 | May 25, 2022 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2017 | May 25, 2022 | SAP_001.pdf |
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| 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 |
|---|---|
| C000624616 | vivitrol |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Buprenorphine |
| Drug |
5-week buprenorphine taper |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Regimen 2 | 5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg Buprenorphine: 5-week buprenorphine taper | 0 | 5 | 1 | 5 | 0 | 5 |
|
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| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |