77
Participants
Start Date
June 30, 2013
Primary Completion Date
July 31, 2020
Study Completion Date
July 31, 2020
injectable naltrexone
Vivitrol is an extended-release, microsphere formulation of naltrexone designed to be administered by intramuscular (IM) gluteal injection every 4 weeks or once a month. After IM injection, the naltrexone plasma concentration time profile is characterized by a transient initial peak, which occurs approximately 2 hours after injection, followed by a second peak observed approximately 2 - 3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month.
placebo comparator
this placebo has no specific pharmacological activity
Federal Medical Research Center for Psychiatry and Narcology (FMRC), Moscow
National Institute on Drug Abuse (NIDA)
NIH
University of Pennsylvania
OTHER