A Double-blind, Placebo-Controlled Study of Oral Nalmefene for Alcohol Dependence
| Autor: | Fernando R. Salvato, Lauren D. Williams, R.B. Cutler, Eva C. Ritvo, Barbara J. Mason |
|---|---|
| Rok vydání: | 1999 |
| Předmět: |
Alcohol Drinking
medicine.drug_class Narcotic Antagonists Temperance media_common.quotation_subject Placebo-controlled study Administration Oral Placebo Drug Administration Schedule Naltrexone law.invention Placebos Double-Blind Method Arts and Humanities (miscellaneous) Randomized controlled trial law Secondary Prevention medicine Humans Nalmefene media_common Dose-Response Relationship Drug Ethanol business.industry Alcohol dependence Abstinence Alcoholism Psychiatry and Mental health Treatment Outcome Breath Tests Anesthesia business Opioid antagonist medicine.drug |
| Zdroj: | Archives of General Psychiatry. 56:719 |
| ISSN: | 0003-990X |
| DOI: | 10.1001/archpsyc.56.8.719 |
| Popis: | Nalmefene is a newer opioid antagonist that is structurally similar to naltrexone but with a number of potential pharmacological advantages for the treatment of alcohol dependence, including no dose-dependent association with toxic effects to the liver, greater oral bioavailability, longer duration of antagonist action, and more competitive binding with opioid receptor subtypes that are thought to reinforce drinking.A double-blind, placebo-controlled trial was conducted to evaluate the safety and efficacy of 2 doses of oral nalmefene for alcohol dependence. The 105 outpatient volunteers were abstinent for a mean of 2 weeks prior to random assignment to the placebo or 20- or 80-mg/d dose nalmefene groups for 12 weeks. Cognitive behavioral therapy was provided weekly during treatment. Self-reported drinking or abstinence was confirmed by determinations of breath alcohol concentration and by collateral informant reports.Outcomes did not differ between the 20- and 80-mg dose nalmefene groups. Significantly fewer patients treated with nalmefene than patients given placebo relapsed to heavy drinking through 12 weeks of treatment (P.02), with a significant treatment effect at the first weekly study visit (P.02). The odds ratio of relapsing to heavy drinking was 2.4 times greater with placebo compared with nalmefene (95% confidence interval, 1.05-5.59). Patients treated with nalmefene also had fewer subsequent relapses (P.03) than patients given placebo.Treatment with nalmefene was effective in preventing relapse to heavy drinking relative to placebo in alcohol-dependent outpatients and was accompanied by acceptable side effects. |
| Databáze: | OpenAIRE |
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