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| Name | Class |
|---|---|
| Alkermes, Inc. | INDUSTRY |
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Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has been demonstrated in clinical trials, raising the prospect of integrating pharmacologic treatment for alcohol dependence into general medical care settings. However, the feasibility of implementing this United States Food and Drug Administration approved treatment in the front-line settings in which it is most needed has not been demonstrated. This is an open-label pilot feasibility study of implementing treatment with Vivitrol in primary care medical clinics in a safety net hospital system affiliated with an urban academic center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended release injectable naltrexone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended release injectable naltrexone (Vivitrol) | Drug | Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc N Gourevitch, MD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20363090 | Result | Lee JD, Grossman E, DiRocco D, Truncali A, Hanley K, Stevens D, Rotrosen J, Gourevitch MN. Extended-release naltrexone for treatment of alcohol dependence in primary care. J Subst Abuse Treat. 2010 Jul;39(1):14-21. doi: 10.1016/j.jsat.2010.03.005. Epub 2010 Apr 2. | |
| 22985676 | Derived | Lee JD, Grossman E, Huben L, Manseau M, McNeely J, Rotrosen J, Stevens D, Gourevitch MN. Extended-release naltrexone plus medical management alcohol treatment in primary care: findings at 15 months. J Subst Abuse Treat. 2012 Dec;43(4):458-62. doi: 10.1016/j.jsat.2012.08.012. Epub 2012 Sep 15. |
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Four consented patients were ineligible due to elevated liver function tests (n = 2), opioid dependence (n =1), and an uncontrolled psychiatric condition (n = 1). Seventy two participants met eligibility criteria and consented to study involvement, sixty-five participants presented for the initial treatment visit.
The study began July 2007. Community recruitment was performed from August 2007 to September 2008 in the primary care clinics of Bellevue Hospital and Gouverneur Diagnostic and Treatment Centers, two public hospital facilities in lower Manhattan. 116 persons contacted study staff regarding possible participation, and 76 were consented and screened.
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Release Injectable Naltrexone | This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Release Injectable Naltrexone | This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care. |
| 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 Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections | Per protocol | Posted | Number | Percent of participants | 4 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 | Extended Release Injectable Naltrexone | This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe injection site reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| any injection site reaction | Injury, poisoning and procedural complications | Systematic Assessment |
There was no formal control arm. Drinking and satisfaction outcomes were self-reported, these outcomes and Adverse Event data were not available for those lost to follow-up. The drinking Timeline Follow-Back is subject to recall and response biases.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Gourevitch, MD, MPH | New York University School of Medicine | 212-263-8553 | marc.gourevitch@nyumc.org |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
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|
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| 2 |
| 65 |
| 45 |
| 65 |
| unexpected pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| fatigue | General disorders | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
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| flu-like symptoms | General disorders | Systematic Assessment |
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| insomnia | General disorders | Systematic Assessment |
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| AST/ALT >5x normal | General disorders | Systematic Assessment |
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| other complaints | General disorders | Systematic Assessment |
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