Status:
COMPLETED
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
Lead Sponsor:
Alkermes, Inc.
Conditions:
Opiate Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 o...
Eligibility Criteria
Inclusion
- Primary
- Health care professional (eg, physician, osteopath, nurse, pharmacist)
- 18 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
- Primary
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00834080
Start Date
March 1 2009
End Date
May 1 2012
Last Update
December 11 2018
Active Locations (11)
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1
Alkermes Clinical Study Site
Colton, California, United States, 92324
2
Alkermes Clinical Study Site
Oceanside, California, United States, 92056
3
Alkermes Clinical Study Site
Lauderhill, Florida, United States, 33319
4
Alkermes Clinical Study Site
Hoffman Estates, Illinois, United States, 60194