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The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medisorb naltrexone 380 mg (VIVITROL) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medisorb naltrexone 380 mg | Drug | Intramuscular (IM) injection administered once every 4 weeks for up to 2 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. | A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period). | 2 years (Baseline to end of study) |
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Primary Inclusion Criteria:
Primary Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alkermes Medical Director | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Clinical Study Site | Colton | California | 92324 | United States | ||
| Alkermes Clinical Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28358754 | Result | Earley PH, Zummo J, Memisoglu A, Silverman BL, Gastfriend DR. Open-label Study of Injectable Extended-release Naltrexone (XR-NTX) in Healthcare Professionals With Opioid Dependence. J Addict Med. 2017 May/Jun;11(3):224-230. doi: 10.1097/ADM.0000000000000302. |
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Potential subjects must have participated in a detoxification program for opioid dependence. Subjects participated in psychosocial treatment throughout their study participation.
This study had a 12 month recruitment period (May 2009 through April 2010). A total of 11 sites in the United States participated. Principal Investigators were addiction specialists who had contact with health care professionals in need of treatment for opioid dependence.
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| ID | Title | Description |
|---|---|---|
| FG000 | VIVITROL | Study drug was administered by intramuscular (IM) injection once monthly for 24 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Oceanside |
| California |
| 92056 |
| United States |
| Alkermes Clinical Study Site | Lauderhill | Florida | 33319 | United States |
| Alkermes Clinical Study Site | Hoffman Estates | Illinois | 60194 | United States |
| Alkermes Clinical Study Site | St Louis | Missouri | 63109 | United States |
| Alkermes Clinical Study Site | Elmsford | New York | 10523 | United States |
| Alkermes Clinical Study Site | Canton | Ohio | 44718 | United States |
| Alkermes Clinical Study Site | Philadelphia | Pennsylvania | 19118 | United States |
| Alkermes Clinical Study Site | Philadelphia | Pennsylvania | 19125 | United States |
| Alkermes Clinical Study Site | Austin | Texas | 78754 | United States |
| Alkermes Clinical Study Site | Dallas | Texas | 75225 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Population, defined as all subjects who received at least 1 dose (injection) of study drug, was used for presentation and analysis of both safety and efficacy data.
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| ID | Title | Description |
|---|---|---|
| BG000 | VIVITROL, 380mg |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. | A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period). | The Safety Population, defined as all subjects who received at least 1 dose (injection) of study drug, was used for presentation and analysis of both safety and efficacy data. | Posted | Number | participants | 2 years (Baseline to end of study) |
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|
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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 | Medisorb Naltrexone 380 mg (VIVITROL) | Study drug was administered by intramuscular (IM) injection once monthly for 24 months. | 2 | 38 | 37 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head Injury | Injury, poisoning and procedural complications | MedDRA (12.0) |
| ||
| Suicide Attempt | Psychiatric disorders | MedDRA (12.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (12.0) |
| ||
| Fatigue | General disorders | MedDRA (12.0) |
| ||
| Injection site induration | General disorders | MedDRA (12.0) |
| ||
| Injection site mass | General disorders | MedDRA (12.0) |
| ||
| Injection site nodule | General disorders | MedDRA (12.0) |
| ||
| Irritability | General disorders | MedDRA (12.0) |
| ||
| Chest pain | General disorders | MedDRA (12.0) |
| ||
| Discomfort | General disorders | MedDRA (12.0) |
| ||
| Oedema peripheral | General disorders | MedDRA (12.0) |
| ||
| Pyrexia | General disorders | MedDRA (12.0) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (12.0) |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.0) |
| ||
| Toothache | Gastrointestinal disorders | MedDRA (12.0) |
| ||
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.0) |
| ||
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) |
| ||
| Constipation | Gastrointestinal disorders | MedDRA (12.0) |
| ||
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) |
| ||
| Anxiety | Psychiatric disorders | MedDRA (12.0) |
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| Depression | Psychiatric disorders | MedDRA (12.0) |
| ||
| Insomnia | Psychiatric disorders | MedDRA (12.0) |
| ||
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA (12.0) |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) |
| ||
| Bronchitis | Infections and infestations | MedDRA (12.0) |
| ||
| Sinusitis | Infections and infestations | MedDRA (12.0) |
| ||
| Tooth abscess | Infections and infestations | MedDRA (12.0) |
| ||
| Urinary tract infection | Infections and infestations | MedDRA (12.0) |
| ||
| Influenza | Infections and infestations | MedDRA (12.0) |
| ||
| Headache | Nervous system disorders | MedDRA (12.0) |
| ||
| Dizziness | Nervous system disorders | MedDRA (12.0) |
| ||
| Amnesia | Nervous system disorders | MedDRA (12.0) |
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| Disturbance in attention | Nervous system disorders | MedDRA (12.0) |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.0) |
| ||
| Increased appetite | Metabolism and nutrition disorders | MedDRA (12.0) |
| ||
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.0) |
| ||
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (12.0) |
| ||
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (12.0) |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
| ||
| Hypertension | Vascular disorders | MedDRA (12.0) |
| ||
| Seasonal allergy | Immune system disorders | MedDRA (12.0) |
|
After screening 49 subjects, Alkermes made a business decision to stop enrollment, resulting in 38 total subjects enrolled.
A copy of such disclosure must be given to Alkermes for review at least sixty (60) days prior to submission for publication, presentation or delivery to any other party. Revisions to such disclosure will be negotiated in good faith by the Institution, Principal Investigator and Alkermes. Expedited reviews for abstracts or poster presentations may be arranged if mutually agreeable to Alkermes and the Institution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernard L. Silverman, MD | Alkermes, Inc. | 781-609-6000 | Bernard.Silverman@alkermes.com |
| 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 |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| 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 |
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