ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry
- Conditions
- Opioid Dependence
- Registration Number
- NCT01422837
- Lead Sponsor
- Alkermes, Inc.
- Brief Summary
The objective of the VIVITROL Registry is to gather real world data on opioid dependence and to provide understanding of the health economics of opioid dependence.
- Detailed Description
The VIVITROL Registry is an observational, open-label, single-arm, multi-center registry of patients who have initiated treatment with VIVITROL for prevention of relapse to opioid dependence, following opioid detoxification.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 403
- Patient is aged 18 years or older
- 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
- Prior use of VIVITROL
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Innovation Laboratory/PEARL
🇺🇸Johnson City, Tennessee, United States
Arkansas Psychiatric Clinc
🇺🇸Little Rock, Arkansas, United States
Psychotherapy Services, Etc.
🇺🇸Groton, Connecticut, United States
Gosnold-Thorne Counseling Center
🇺🇸Centerville, Massachusetts, United States
Jacqueline Boutrouille, MD
🇺🇸Tamarac, Florida, United States
Jasper Health
🇺🇸Media, Pennsylvania, United States
Adolescent and Family Health Center, PC
🇺🇸Midlothian, Virginia, United States
PACT Atlanta
🇺🇸Decatur, Georgia, United States
Alliance Clinical Research
🇺🇸Winter Park, Florida, United States
Holiner Psychiatric Group
🇺🇸Dallas, Texas, United States
Lenae White, MD, PA
🇺🇸Dallas, Texas, United States
Assisted Recovery Centers of America
🇺🇸Saint Louis, Missouri, United States
Urschel Recovery Science Institute
🇺🇸Dallas, Texas, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Chessen and Associates
🇺🇸Newport News, Virginia, United States
The NeuroBehavioral Institute of Colorado, PC
🇺🇸Lone Tree, Colorado, United States
Atlanta Institute of Medicine and Research
🇺🇸Atlanta, Georgia, United States
Dr. Michael Sanders
🇺🇸Great Neck, New York, United States
Kenneth C. Russ, MD
🇺🇸Palm Springs, California, United States
Dr. Li's Clinic
🇺🇸Milford, Massachusetts, 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
Utah Addiction Medicine & Counseling
🇺🇸Bountiful, Utah, United States
Amy Solomon, MD
🇺🇸Ben Lomond, California, United States
Tarzana Treatment Centers
🇺🇸Tarzana, California, United States
Touchstone Medical Group
🇺🇸Clovis, California, United States
Institute of Addiction Medicine
🇺🇸Plymouth Meeting, Pennsylvania, United States
Creekside Center for Integrative Medicine
🇺🇸Bellevue, Washington, United States
Child and Adolescent Psychiatry
🇺🇸Bothell, Washington, United States