Efficacy and Tolerability of Long-Acting Injectable Formulation of Nalmefene (Nalmefene Consta 393.1 mg) for Opioid Relapse Prevention: A Multicentre, Open-Label, Randomised Controlled Trial
Objective: To determine the efficacy and
tolerability of a long-acting intramuscular formulation of Nalmefene (Nalmefene
Consta 393.1 mg) for the treatment of opioid-dependent patients. Design,
Setting, and Participants: A 12 weeks, open-label, randomised controlled trial
conducted between June 2009-July 2011, at 14 Hospital-based drug clinics, in
the 12 countries. Participants were 18 years or older, had Diagnostic and
Statistical Manual of Mental Disorders-5 opioid use disorder. Of the 3200
individuals screened, 3000 (93.7%) adults were randomized 1500 participants to
receive injections of Long-acting depot formulations ofNalmefene (Nalmefene
Consta 393.1 mg) given intramuscularly once in 12 weeks and 1500participants to
receive extended-release Naltrexone (Vivitrol 380 mg), administered
intramuscularly every fourth week for 12 weeks. Main Outcomes and Measures: The
primary endpoints (protocol) were: Confirmed Opioid abstinence (percentage i.e. the number of patients who achieved complete abstinence during week 12).
Confirmed abstinence or “opioid-free” was defined as a negative urine drug test
for opioids and no self-reported opioid use. Weeks 1 - 4 were omitted from this
endpoint to allow for stabilization of abstinence. Secondary end points
included a number of days in treatment, treatment retention and craving. The
study also investigated, on 275 participants, degree and time course of
mu-opioid receptor occupancy following single doses of Nalmefene
extended-release injection (Nalmefene Consta 393.1 mg) as well as the plasma
concentration of Nalmefene and Nalmefene-3-O-glucuronide. Safety was assessed
by adverse event reporting. Results: Of 3000 participants, mean (SD) age was
27.1 (±4.8) years and 831 (27.7%) were women. 1500 individuals were randomized
to receive injections of Long-acting depot
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