Supported by NIAAA Grant N43 AA01002.
A Pilot Evaluation of the Safety and Tolerability of Repeat Dose Administration of Long-Acting Injectable Naltrexone (Vivitrex®) in Patients With Alcohol Dependence
Version of Record online: 3 MAY 2006
Alcoholism: Clinical and Experimental Research
Volume 28, Issue 9, pages 1356–1361, September 2004
How to Cite
Johnson, B. A., Ait-Daoud, N., Aubin, H.-J., van den Brink, W., Guzzetta, R., Loewy, J., Silverman, B. and Ehrich, E. (2004), A Pilot Evaluation of the Safety and Tolerability of Repeat Dose Administration of Long-Acting Injectable Naltrexone (Vivitrex®) in Patients With Alcohol Dependence. Alcoholism: Clinical and Experimental Research, 28: 1356–1361. doi: 10.1097/01.ALC.0000139823.30096.52
- Issue online: 3 MAY 2006
- Version of Record online: 3 MAY 2006
- Received for publication March 10, 2004; accepted May 28, 2004.
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.