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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.
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:
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.
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Inclusion Criteria:
Exclusion Criteria:
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The VIVITROL Registry will enroll patients who have been prescribed VIVITROL for the prevention of relapse to opioid dependence, following opioid detoxification.
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| Name | Affiliation | Role |
|---|---|---|
| Alkermes Medical Director | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assisted Recovery Centers of America | Phoenix | Arizona | 85014 | United States | ||
| Arkansas Psychiatric Clinc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29493836 | Result | 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. |
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| Little Rock |
| Arkansas |
| 72223 |
| United States |
| Amy Solomon, MD | Ben Lomond | California | 95005 | United States |
| Touchstone Medical Group | Clovis | California | 93611 | United States |
| Kenneth C. Russ, MD | Palm Springs | California | 92262 | United States |
| Tarzana Treatment Centers | Tarzana | California | 91356 | United States |
| The NeuroBehavioral Institute of Colorado, PC | Lone Tree | Colorado | 80124 | United States |
| Psychotherapy Services, Etc. | Groton | Connecticut | 06340 | United States |
| Jacqueline Boutrouille, MD | Tamarac | Florida | 33321 | United States |
| Alliance Clinical Research | Winter Park | Florida | 32792 | United States |
| Atlanta Institute of Medicine and Research | Atlanta | Georgia | 30328 | United States |
| PACT Atlanta | Decatur | Georgia | 30030 | United States |
| Gosnold-Thorne Counseling Center | Centerville | Massachusetts | 02632 | United States |
| Dr. Li's Clinic | Milford | Massachusetts | 01757 | United States |
| Assisted Recovery Centers of America | St Louis | Missouri | 63109 | United States |
| Dent Neurologic Institute | Amherst | New York | 14226 | United States |
| Dr. Michael Sanders | Great Neck | New York | 11021 | United States |
| Fakhouri Medical | Hopewell Junction | New York | 12533 | United States |
| Parallax Center | New York | New York | 10016 | United States |
| Healing Comfort Clinic | Corvallis | Oregon | 97330 | United States |
| Jasper Health | Media | Pennsylvania | 19063 | United States |
| Institute of Addiction Medicine | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Innovation Laboratory/PEARL | Johnson City | Tennessee | 37604 | United States |
| Urschel Recovery Science Institute | Dallas | Texas | 75225 | United States |
| Holiner Psychiatric Group | Dallas | Texas | 75230 | United States |
| Lenae White, MD, PA | Dallas | Texas | 75231 | United States |
| Utah Addiction Medicine & Counseling | Bountiful | Utah | 84010 | United States |
| Adolescent and Family Health Center, PC | Midlothian | Virginia | 23114 | United States |
| Chessen and Associates | Newport News | Virginia | 23606 | United States |
| Creekside Center for Integrative Medicine | Bellevue | Washington | 98005 | United States |
| Child and Adolescent Psychiatry | Bothell | Washington | 98011 | United States |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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