NCT01422837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

2.2 years

First QC Date

August 23, 2011

Last Update Submit

November 15, 2018

Conditions

Keywords

opioiddependenceVIVITROL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Prior use of VIVITROL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Assisted Recovery Centers of America

Phoenix, Arizona, 85014, United States

Location

Arkansas Psychiatric Clinc

Little Rock, Arkansas, 72223, United States

Location

Amy Solomon, MD

Ben Lomond, California, 95005, United States

Location

Touchstone Medical Group

Clovis, California, 93611, United States

Location

Kenneth C. Russ, MD

Palm Springs, California, 92262, United States

Location

Tarzana Treatment Centers

Tarzana, California, 91356, United States

Location

The NeuroBehavioral Institute of Colorado, PC

Lone Tree, Colorado, 80124, United States

Location

Psychotherapy Services, Etc.

Groton, Connecticut, 06340, United States

Location

Jacqueline Boutrouille, MD

Tamarac, Florida, 33321, United States

Location

Alliance Clinical Research

Winter Park, Florida, 32792, United States

Location

Atlanta Institute of Medicine and Research

Atlanta, Georgia, 30328, United States

Location

PACT Atlanta

Decatur, Georgia, 30030, United States

Location

Gosnold-Thorne Counseling Center

Centerville, Massachusetts, 02632, United States

Location

Dr. Li's Clinic

Milford, Massachusetts, 01757, United States

Location

Assisted Recovery Centers of America

St Louis, Missouri, 63109, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Dr. Michael Sanders

Great Neck, New York, 11021, United States

Location

Fakhouri Medical

Hopewell Junction, New York, 12533, United States

Location

Parallax Center

New York, New York, 10016, United States

Location

Healing Comfort Clinic

Corvallis, Oregon, 97330, United States

Location

Jasper Health

Media, Pennsylvania, 19063, United States

Location

Institute of Addiction Medicine

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Innovation Laboratory/PEARL

Johnson City, Tennessee, 37604, United States

Location

Urschel Recovery Science Institute

Dallas, Texas, 75225, United States

Location

Holiner Psychiatric Group

Dallas, Texas, 75230, United States

Location

Lenae White, MD, PA

Dallas, Texas, 75231, United States

Location

Utah Addiction Medicine & Counseling

Bountiful, Utah, 84010, United States

Location

Adolescent and Family Health Center, PC

Midlothian, Virginia, 23114, United States

Location

Chessen and Associates

Newport News, Virginia, 23606, United States

Location

Creekside Center for Integrative Medicine

Bellevue, Washington, 98005, United States

Location

Child and Adolescent Psychiatry

Bothell, Washington, 98011, United States

Location

Related 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.14199. Epub 2018 Apr 1.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Alkermes Medical Director

    Alkermes, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 24, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 16, 2018

Record last verified: 2018-11

Locations