ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry
NCT ID: NCT01422837
Last Updated: 2018-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
403 participants
OBSERVATIONAL
2011-08-31
2013-10-31
Brief Summary
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Detailed Description
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The objectives of the VIVITROL Registry are:
* To describe characteristics of patients receiving VIVITROL for opioid dependence in real-world clinical practice.
* To assess clinical, health economic, and health-related quality of life (HRQOL) outcomes in a broad population of patients receiving VIVITROL in real-world clinical practice.
* To provide additional data to inform future research on VIVITROL.
Patients 18 years of age or older who have been determined by their participating prescriber to be an appropriate candidate for VIVITROL treatment may be offered enrollment into the registry. The decision to treat a patient with VIVITROL will be made by the patient's participating prescriber independent of the registry. VIVITROL will not be provided to patients enrolled in the registry in exchange for their participation; patients will receive commercially available VIVITROL via a standard prescription that will be filled through standard commercial channels.
Patients will be observed while receiving VIVITROL and for six months after they discontinue VIVITROL use. The registry is non-interventional; it will neither direct the treatment plan for enrolled patients nor define the frequency of follow-up visits of each patient. A patient's participation in the registry will not influence or direct patient treatment procedures or follow-up care. It is expected that patients will be seen at least once per month during active VIVITROL treatment to receive their monthly injection.
During the standard monthly injection visits, patients will be asked to provide detailed health economics information using a variety of questionnaires, including the EQ-5D and SF-12v2.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patient is diagnosed with a current opioid dependence for which treatment with VIVITROL is being initiated
* Patient has provided written informed consent
* Patient is willing and able to provide the information to be collected via the registry's interviews and questionnaires
* Patient expects to be available for ongoing registry participation
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alkermes Medical Director
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Assisted Recovery Centers of America
Phoenix, Arizona, United States
Arkansas Psychiatric Clinc
Little Rock, Arkansas, United States
Amy Solomon, MD
Ben Lomond, California, United States
Touchstone Medical Group
Clovis, California, United States
Kenneth C. Russ, MD
Palm Springs, California, United States
Tarzana Treatment Centers
Tarzana, California, United States
The NeuroBehavioral Institute of Colorado, PC
Lone Tree, Colorado, United States
Psychotherapy Services, Etc.
Groton, Connecticut, United States
Jacqueline Boutrouille, MD
Tamarac, Florida, United States
Alliance Clinical Research
Winter Park, Florida, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia, United States
PACT Atlanta
Decatur, Georgia, United States
Gosnold-Thorne Counseling Center
Centerville, Massachusetts, United States
Dr. Li's Clinic
Milford, Massachusetts, United States
Assisted Recovery Centers of America
St Louis, Missouri, United States
Dent Neurologic Institute
Amherst, New York, United States
Dr. Michael Sanders
Great Neck, New York, United States
Fakhouri Medical
Hopewell Junction, New York, United States
Parallax Center
New York, New York, United States
Healing Comfort Clinic
Corvallis, Oregon, United States
Jasper Health
Media, Pennsylvania, United States
Institute of Addiction Medicine
Plymouth Meeting, Pennsylvania, United States
Innovation Laboratory/PEARL
Johnson City, Tennessee, United States
Urschel Recovery Science Institute
Dallas, Texas, United States
Holiner Psychiatric Group
Dallas, Texas, United States
Lenae White, MD, PA
Dallas, Texas, United States
Utah Addiction Medicine & Counseling
Bountiful, Utah, United States
Adolescent and Family Health Center, PC
Midlothian, Virginia, United States
Chessen and Associates
Newport News, Virginia, United States
Creekside Center for Integrative Medicine
Bellevue, Washington, United States
Child and Adolescent Psychiatry
Bothell, Washington, United States
Countries
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References
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Saxon AJ, Akerman SC, Liu CC, Sullivan MA, Silverman BL, Vocci FJ. Extended-release naltrexone (XR-NTX) for opioid use disorder in clinical practice: Vivitrol's Cost and Treatment Outcomes Registry. Addiction. 2018 Aug;113(8):1477-1487. doi: 10.1111/add.14199. Epub 2018 Apr 1.
Other Identifiers
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ALK21-025
Identifier Type: -
Identifier Source: org_study_id
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