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A Pilot Evaluation of the Safety and Tolerability of Repeat Dose Administration of Long‐Acting Injectable Naltrexone (Vivitrex®) in Patients With Alcohol Dependence
Author(s) -
Johnson Bankole A.,
AitDaoud Nassima,
Aubin HenriJean,
Brink Wim,
Guzzetta Richard,
Loewy John,
Silverman Bernard,
Ehrich Elliot
Publication year - 2004
Publication title -
alcoholism: clinical and experimental research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.267
H-Index - 153
eISSN - 1530-0277
pISSN - 0145-6008
DOI - 10.1097/01.alc.0000139823.30096.52
Subject(s) - naltrexone , tolerability , medicine , alcohol , alcohol dependence , pharmacology , administration (probate law) , anesthesia , adverse effect , opioid , chemistry , political science , receptor , biochemistry , law
Background: Oral naltrexone is currently used as part of a treatment regimen for alcohol‐dependent patients, but its clinical utility is hampered by poor patient adherence. A long‐acting injectable naltrexone formulation (Vivitrex®) was designed to facilitate patient adherence by providing an extended duration of therapeutic naltrexone over 1 month, thereby eliminating the need for daily dosing. Methods: A multicenter, randomized, double‐blind, placebo‐controlled pilot study was conducted to evaluate the safety and tolerability of intramuscular repeat dose administration of this extended‐release naltrexone formulation in DSM‐IV alcohol‐dependent patients. Thirty patients were randomized to treatment with injectable naltrexone (400 mg; n = 25) or a matching placebo injection ( n = 5) and were dosed once every 28 days over 4 months. Psychosocial treatment was offered to patients in both treatment groups. Outcome measures related to drinking activity and trough plasma concentrations of naltrexone and its primary metabolite, 6‐β‐naltrexol, were evaluated. Results: Injectable naltrexone was generally safe and well tolerated. Reported adverse events were mild to moderate and resolved without intervention; only two patients discontinued due to adverse events. The most common adverse events (nausea and headache) occurred at a similar rate for patients in both treatment groups. Pharmacokinetic analysis confirmed that therapeutic levels of naltrexone were delivered throughout the four 1‐month treatment cycles. Conclusions: The results of this pilot study provide the basis and methods for a larger, more definitive trial to determine the utility of this long‐acting injectable naltrexone formulation in the treatment of alcohol‐dependent patients.