The highest incidence of relapse in patients with alcohol dependence occurs
during the first few months following cessation of drinking. In the United
States, currently available drug therapies for alcohol dependence include
aversion therapy with disulfiram, and naltrexone, an opioid antagonist.
Naltrexone has been moderately successful in some small trials, but dose-dependent
liver toxicity and a high incidence of nausea limit its use. Acamprosate,
available internationally, is being studied in the United States as a nonaversive
pharmacotherapeutic agent. Nalmefene is a newer opioid antagonist that,
like naltrexone, has no agonist activity and no abuse potential. Additional
advantages include a longer half-life, greater bioavailability and no dose-dependent
Patients were given a two-week trial of a placebo medication while eligibility
criteria were assessed. The primary criteria required that patients be between
18 and 65 years of age and have a Diagnostic and Statistical Manual of Mental
Disorders (DSM-III-R) diagnosis of alcohol dependence. At baseline, all
patients underwent electrocardiography, laboratory tests (including determination
of gamma-glutamyltransferase level) and a urine toxicology screen for drug
abuse. Exclusion criteria included a history of illicit drug dependence,
current use of narcotic or psychotropic medications, history of cirrhosis
or baseline liver function studies more than twice the normal levels.
There has also been development of an implant that slowly releases nalmefene over a period of six months.
Nalmefene has been shown to have an effect even in people who are not trying to quit drinking, meaning it is more than a placebo.