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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT01422837
First received: August 23, 2011
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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
Opioid Dependence

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: VIvitrol's Cost and Treatment Outcomes RegistrY

Resource links provided by NLM:


Further study details as provided by Alkermes:

Estimated Enrollment: 400
Study Start Date: August 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422837

  Show 31 Study Locations
Sponsors and Collaborators
Alkermes
  More Information

No publications provided

Responsible Party: Alkermes
ClinicalTrials.gov Identifier: NCT01422837     History of Changes
Other Study ID Numbers: ALK21-025
Study First Received: August 23, 2011
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alkermes:
opioid
dependence
VIVITROL

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014