Clinical trial NCT00834080: ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opiate Dependence
Keywords: opioid dependence
VIVITROL
opioid-related disorders
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
timeFrame: 2 years (Baseline to end of study)
Secondary outcomes:
Other outcomes:
Locations:
city: Colton
country: United States
facility: Alkermes Clinical Study Site
state: California
city: Oceanside
country: United States
facility: Alkermes Clinical Study Site
state: California
city: Lauderhill
country: United States
facility: Alkermes Clinical Study Site
state: Florida
city: Hoffman Estates
country: United States
facility: Alkermes Clinical Study Site
state: Illinois
city: Saint Louis
country: United States
facility: Alkermes Clinical Study Site
state: Missouri
city: Elmsford
country: United States
facility: Alkermes Clinical Study Site
state: New York
city: Canton
country: United States
facility: Alkermes Clinical Study Site
state: Ohio
city: Philadelphia
country: United States
facility: Alkermes Clinical Study Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Alkermes Clinical Study Site
state: Pennsylvania
city: Austin
country: United States
facility: Alkermes Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Alkermes Clinical Study Site
state: Texas
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.