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

Opioid Dependence Clinical Trial

— VICTORY  

Official title:

VIvitrol's Cost and Treatment Outcomes RegistrY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422837
• Other study ID #: ALK21-025
• Status: Completed
• Start date: August 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2018
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Dependence

Locations

Country	Name	City	State
United States	Dent Neurologic Institute	Amherst	New York
United States	Atlanta Institute of Medicine and Research	Atlanta	Georgia
United States	Creekside Center for Integrative Medicine	Bellevue	Washington
United States	Amy Solomon, MD	Ben Lomond	California
United States	Child and Adolescent Psychiatry	Bothell	Washington
United States	Utah Addiction Medicine & Counseling	Bountiful	Utah
United States	Gosnold-Thorne Counseling Center	Centerville	Massachusetts
United States	Touchstone Medical Group	Clovis	California
United States	Healing Comfort Clinic	Corvallis	Oregon
United States	Holiner Psychiatric Group	Dallas	Texas
United States	Lenae White, MD, PA	Dallas	Texas
United States	Urschel Recovery Science Institute	Dallas	Texas
United States	PACT Atlanta	Decatur	Georgia
United States	Dr. Michael Sanders	Great Neck	New York
United States	Psychotherapy Services, Etc.	Groton	Connecticut
United States	Fakhouri Medical	Hopewell Junction	New York
United States	Innovation Laboratory/PEARL	Johnson City	Tennessee
United States	Arkansas Psychiatric Clinc	Little Rock	Arkansas
United States	The NeuroBehavioral Institute of Colorado, PC	Lone Tree	Colorado
United States	Jasper Health	Media	Pennsylvania
United States	Adolescent and Family Health Center, PC	Midlothian	Virginia
United States	Dr. Li's Clinic	Milford	Massachusetts
United States	Parallax Center	New York	New York
United States	Chessen and Associates	Newport News	Virginia
United States	Kenneth C. Russ, MD	Palm Springs	California
United States	Assisted Recovery Centers of America	Phoenix	Arizona
United States	Institute of Addiction Medicine	Plymouth Meeting	Pennsylvania
United States	Assisted Recovery Centers of America	Saint Louis	Missouri
United States	Jacqueline Boutrouille, MD	Tamarac	Florida
United States	Tarzana Treatment Centers	Tarzana	California
United States	Alliance Clinical Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Saxon AJ, Akerman SC, Liu CC, Sullivan MA, Silverman BL, Vocci FJ. Extended-release naltrexone (XR-NTX) for opioid use disorder in clinical practice: Vivitrol's Cost and Treatment Outcomes Registry. Addiction. 2018 Aug;113(8):1477-1487. doi: 10.1111/add.1 — View Citation