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

Alkermes

Status: Completed

Conditions: Opioid Dependence

Study type: Observational

Funder types: Industry

Identifiers

NCT01422837

ALK21-025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 403 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Prior use of VIVITROL