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

Status:	Completed
Conditions:	Psychiatric, Gastrointestinal
Therapuetic Areas:	Gastroenterology, Psychiatry / Psychology
Healthy:	No
Age Range:	18 - Any
Updated:	12/13/2018
Start Date:	March 2009
End Date:	May 2012

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

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.

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

We found this trial at

sites

Alkermes Clinical Study Site

Elmsford, New York 10523

from

Elmsford, NY