Opioid DependenceVICTORYNCT01422837
ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry
An observational study of Opioid Dependence, run by Alkermes, Inc. at 31 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence
- How many people
- 403 participants
- Where
- 31 sitesUnited States
- Study dates
- Aug 2011to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The VIVITROL Registry will enroll patients who have been prescribed VIVITROL for the prevention of relapse to opioid dependence, following opioid detoxification.
Who may be able to join
- 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
Who cannot join
- Prior use of VIVITROL
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Dent Neurologic Institute
Amherst, New York, 14226
Atlanta Institute of Medicine and Research
Atlanta, Georgia, 30328
Creekside Center for Integrative Medicine
Bellevue, Washington, 98005
Amy Solomon, MD
Ben Lomond, California, 95005
Child and Adolescent Psychiatry
Bothell, Washington, 98011
Utah Addiction Medicine & Counseling
Bountiful, Utah, 84010
Gosnold-Thorne Counseling Center
Centerville, Massachusetts, 02632
Touchstone Medical Group
Clovis, California, 93611
Healing Comfort Clinic
Corvallis, Oregon, 97330
Urschel Recovery Science Institute
Dallas, Texas, 75225
Holiner Psychiatric Group
Dallas, Texas, 75230
Lenae White, MD, PA
Dallas, Texas, 75231
PACT Atlanta
Decatur, Georgia, 30030
Dr. Michael Sanders
Great Neck, New York, 11021
Psychotherapy Services, Etc.
Groton, Connecticut, 06340
Fakhouri Medical
Hopewell Junction, New York, 12533
Innovation Laboratory/PEARL
Johnson City, Tennessee, 37604
Arkansas Psychiatric Clinc
Little Rock, Arkansas, 72223
The NeuroBehavioral Institute of Colorado, PC
Lone Tree, Colorado, 80124
Jasper Health
Media, Pennsylvania, 19063
Adolescent and Family Health Center, PC
Midlothian, Virginia, 23114
Dr. Li's Clinic
Milford, Massachusetts, 01757
Parallax Center
New York, New York, 10016
Chessen and Associates
Newport News, Virginia, 23606
Kenneth C. Russ, MD
Palm Springs, California, 92262
Assisted Recovery Centers of America
Phoenix, Arizona, 85014
Institute of Addiction Medicine
Plymouth Meeting, Pennsylvania, 19462
Assisted Recovery Centers of America
St Louis, Missouri, 63109
Jacqueline Boutrouille, MD
Tamarac, Florida, 33321
Tarzana Treatment Centers
Tarzana, California, 91356
Alliance Clinical Research
Winter Park, Florida, 32792
About this study
Official title: VIvitrol's Cost and Treatment Outcomes RegistrY
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.
Read the 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.
- Conditions
- Opioid Dependence
- Keywords
- opioid, dependence, VIVITROL
- Medical subject headings
- Opioid-Related Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alkermes Medical Director, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422837
- Sponsor's protocol ID
- ALK21-025
- Acronym
- VICTORY
- Status last verified
- Nov 2018
- First submitted
- 23 Aug 2011
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29493836
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIvitrol's Cost and Treatment Outcomes RegistrY
- ClinicalTrials.gov ID
- NCT01422837
- Acronym / sponsor ID
- VICTORY / ALK21-025
- Conditions
- Opioid Dependence
- Keywords
- opioid, dependence, VIVITROL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The VIVITROL Registry will enroll patients who have been prescribed VIVITROL for the prevention of relapse to opioid dependence, following opioid detoxification.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Prior use of VIVITROL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Results publication: PubMed 29493836Saxon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alkermes Medical Director study director
Alkermes, Inc.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Dependence, run by Alkermes, Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01422837, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.