ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
Open-Label Study of the Safety and Tolerability of VIVITROL Administered to Health Care Professionals Participating in an Extended Outpatient Treatment Program for Opioid Dependence
1 other identifier
interventional
38
1 country
11
Brief Summary
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2009
Typical duration for phase_3
11 active sites
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
First Submitted
Initial submission to the registry
February 2, 2009
CompletedFirst Posted
Study publicly available on registry
February 3, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
July 29, 2013
CompletedDecember 11, 2018
November 1, 2018
3.2 years
February 2, 2009
May 30, 2013
November 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
2 years (Baseline to end of study)
Study Arms (1)
Medisorb naltrexone 380 mg (VIVITROL)
EXPERIMENTALInterventions
Intramuscular (IM) injection administered once every 4 weeks for up to 2 years
Eligibility Criteria
You may qualify if:
- Health care professional (eg, physician, osteopath, nurse, pharmacist)
- years of age or older
- Enrolled or enrolling in an extended outpatient treatment program for opioid dependence
- Women of childbearing potential must agree to use an approved method of contraception for the duration of the study
You may not qualify if:
- Pregnancy and/or lactation
- Evidence of hepatic failure
- Active hepatitis
- Any psychiatric disorder that would compromise ability to complete study requirements
- Recent history of suicidal ideation or attempt
- Current dependence to any drugs other than prescription opioids or heroin, benzodiazepines, caffeine, marijuana, alcohol, or nicotine
- Positive urine drug test or self-reported use of opioids, cocaine, or amphetamines at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (11)
Alkermes Clinical Study Site
Colton, California, 92324, United States
Alkermes Clinical Study Site
Oceanside, California, 92056, United States
Alkermes Clinical Study Site
Lauderhill, Florida, 33319, United States
Alkermes Clinical Study Site
Hoffman Estates, Illinois, 60194, United States
Alkermes Clinical Study Site
St Louis, Missouri, 63109, United States
Alkermes Clinical Study Site
Elmsford, New York, 10523, United States
Alkermes Clinical Study Site
Canton, Ohio, 44718, United States
Alkermes Clinical Study Site
Philadelphia, Pennsylvania, 19118, United States
Alkermes Clinical Study Site
Philadelphia, Pennsylvania, 19125, United States
Alkermes Clinical Study Site
Austin, Texas, 78754, United States
Alkermes Clinical Study Site
Dallas, Texas, 75225, United States
Related Publications (1)
Earley PH, Zummo J, Memisoglu A, Silverman BL, Gastfriend DR. Open-label Study of Injectable Extended-release Naltrexone (XR-NTX) in Healthcare Professionals With Opioid Dependence. J Addict Med. 2017 May/Jun;11(3):224-230. doi: 10.1097/ADM.0000000000000302.
PMID: 28358754RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
After screening 49 subjects, Alkermes made a business decision to stop enrollment, resulting in 38 total subjects enrolled.
Results Point of Contact
- Title
- Bernard L. Silverman, MD
- Organization
- Alkermes, Inc.
Study Officials
- STUDY DIRECTOR
Alkermes Medical Director
Alkermes, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2009
First Posted
February 3, 2009
Study Start
March 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
December 11, 2018
Results First Posted
July 29, 2013
Record last verified: 2018-11