ALK21-025: Vivitrol's Cost & Treatment Outcomes Registry

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Opioid Dependence

Clinical Trial Details

NCT number	NCT01422837
Study type	Observational
Source	Alkermes, Inc.
Contact
Status	Completed
Phase
Start date	August 2011
Completion date	October 2013

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry — VICTORY

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms