Who is sponsoring NCT00834080?

NCT00834080 is sponsored by Alkermes, Inc..

What condition does NCT00834080 study?

NCT00834080 studies Opiate Dependence.

What drugs are being tested in NCT00834080?

Interventions: Medisorb naltrexone 380 mg.

What is the status of NCT00834080?

NCT00834080 is currently COMPLETED.

Last reviewed 2018-11-15 · How we verify

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

NCT00834080 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Alkermes, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	38
Start date	2009-03
Completion	2012-05

Conditions

Opiate Dependence

Interventions

Medisorb naltrexone 380 mg

Primary outcomes

Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. — 2 years (Baseline to end of study)
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).

Countries

United States