Clinical trial NCT01422837: ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry
Official title: VIvitrol's Cost and Treatment Outcomes RegistrY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Dependence
Keywords: opioid
dependence
VIVITROL
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-24
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Assisted Recovery Centers of America
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Psychiatric Clinc
state: Arkansas
city: Ben Lomond
country: United States
facility: Amy Solomon, MD
state: California
city: Clovis
country: United States
facility: Touchstone Medical Group
state: California
city: Palm Springs
country: United States
facility: Kenneth C. Russ, MD
state: California
city: Tarzana
country: United States
facility: Tarzana Treatment Centers
state: California
city: Lone Tree
country: United States
facility: The NeuroBehavioral Institute of Colorado, PC
state: Colorado
city: Groton
country: United States
facility: Psychotherapy Services, Etc.
state: Connecticut
city: Tamarac
country: United States
facility: Jacqueline Boutrouille, MD
state: Florida
city: Winter Park
country: United States
facility: Alliance Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine and Research
state: Georgia
city: Decatur
country: United States
facility: PACT Atlanta
state: Georgia
city: Centerville
country: United States
facility: Gosnold-Thorne Counseling Center
state: Massachusetts
city: Milford
country: United States
facility: Dr. Li's Clinic
state: Massachusetts
city: Saint Louis
country: United States
facility: Assisted Recovery Centers of America
state: Missouri
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Great Neck
country: United States
facility: Dr. Michael Sanders
state: New York
city: Hopewell Junction
country: United States
facility: Fakhouri Medical
state: New York
city: New York
country: United States
facility: Parallax Center
state: New York
city: Corvallis
country: United States
facility: Healing Comfort Clinic
state: Oregon
city: Media
country: United States
facility: Jasper Health
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Institute of Addiction Medicine
state: Pennsylvania
city: Johnson City
country: United States
facility: Innovation Laboratory/PEARL
state: Tennessee
city: Dallas
country: United States
facility: Urschel Recovery Science Institute
state: Texas
city: Dallas
country: United States
facility: Holiner Psychiatric Group
state: Texas
city: Dallas
country: United States
facility: Lenae White, MD, PA
state: Texas
city: Bountiful
country: United States
facility: Utah Addiction Medicine & Counseling
state: Utah
city: Midlothian
country: United States
facility: Adolescent and Family Health Center, PC
state: Virginia
city: Newport News
country: United States
facility: Chessen and Associates
state: Virginia
city: Bellevue
country: United States
facility: Creekside Center for Integrative Medicine
state: Washington
city: Bothell
country: United States
facility: Child and Adolescent Psychiatry
state: Washington
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.14199. Epub 2018 Apr 1.