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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01422837
Recruitment Status : Completed
First Posted : August 24, 2011
Last Update Posted : August 7, 2014
Information provided by (Responsible Party):
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.

Condition or disease
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.

Study Type : Observational
Actual Enrollment : 403 participants
Time Perspective: Prospective
Official Title: VIvitrol's Cost and Treatment Outcomes RegistrY
Study Start Date : August 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The VIVITROL Registry will enroll patients who have been prescribed VIVITROL for the prevention of relapse to opioid dependence, following opioid detoxification.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01422837

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Sponsors and Collaborators
Alkermes, Inc.
Study Director: Bernard L. Silverman, MD Alkermes, Inc.

Responsible Party: Alkermes, Inc. Identifier: NCT01422837     History of Changes
Other Study ID Numbers: ALK21-025
First Posted: August 24, 2011    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014

Keywords provided by Alkermes, Inc.:

Additional relevant MeSH terms:
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents