ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Analgesics, Opioid; Naltrexone

Criteria

Primary Inclusion Criteria:

• 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 Criteria:

• 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