A pilot evaluation of the safety and tolerability of repeat dose administration of long-acting injectable naltrexone (Vivitrex) in patients with alcohol dependence.

摘要: Background: Oral naltrexone is currently used as part of a treatment regimen for alcohol-dependent patients, but its clinical utility hampered by poor patient adherence. A long-acting injectable formulation (Vivitrex®) was designed to facilitate adherence providing an extended duration therapeutic over 1 month, thereby eliminating the need daily dosing. Methods: multicenter, randomized, double-blind, placebo-controlled pilot study conducted evaluate safety and tolerability intramuscular repeat dose administration this extended-release in DSM-IV patients. Thirty patients were randomized with (400 mg; n 25) or matching placebo injection (n 5) dosed once every 28 days 4 months. Psychosocial offered both groups. Outcome measures related drinking activity trough plasma concentrations primary metabolite, 6--naltrexol, evaluated. Results: Injectable generally safe well tolerated. Reported adverse events mild moderate resolved without intervention; only two discontinued due events. The most common (nausea headache) occurred at similar rate Pharmacokinetic analysis confirmed that levels delivered throughout four 1-month cycles. Conclusions: results provide basis methods larger, more definitive trial determine