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

VIvitrol's Cost and Treatment Outcomes RegistrY

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01422837

Acronym

VICTORY

Enrollment

403

Registered

2011-08-24

Start date

2011-08-31

Completion date

2013-10-31

Last updated

2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Dependence

Keywords

opioid, dependence, VIVITROL

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

United States

Outcome results