Overview

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