NCT00678418 - ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence | Biotech Hunter

Enrollment

250

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

October 31, 2009

Study Completion Date

November 30, 2010

Conditions

Opiate Dependence

Interventions

DRUG

VIVITROL® 380 mg

Administered via intramuscular (IM) injection once every 4 weeks for 24 weeks during Part A, followed by once every 4 weeks for 52 weeks in Part B.

DRUG

Placebo

Administered via IM injection once every 4 weeks for 24 weeks during Part A, followed by VIVITROL® 380 mg via IM injection once every 4 weeks for 52 weeks in Part B.

Trial Locations (1)

109074

Ethics Committee within the Federal Authority for Healthcare and Social Development Regulation, Moscow