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CME Released: 4/5/2005
Valid for credit through: 4/5/2006
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April 5, 2005 — A depot form of naltrexone given once per month can significantly reduce the rate of heavy drinking in patients with alcohol dependence, according to the results of a six-month, double-blind, randomized study published in the April 6 issue of JAMA.
"Naltrexone, an opioid antagonist, has been shown to be effective for treatment of alcohol dependence," write James C. Garbutt, MD, from the University of North Carolina School of Medicine in Chapel Hill, and colleagues from the Vivitrex Study Group. "However, adherence to daily oral pharmacotherapy can be problematic, and clinical acceptance and utility of oral naltrexone have been limited."
Between February 2002 and September 2003, 899 individuals were screened at 24 U.S. public hospitals, private and Veterans Administration clinics, and tertiary care medical centers. Of the 899 individuals who were screened, 627 were diagnosed as being actively drinking alcohol-dependent adults and were randomized to receive treatment, and 624 received at least one injection.
The treatment groups consisted of an intramuscular injection of 380 mg of long-acting naltrexone (n = 205), of 190 mg of long-acting naltrexone (n = 210), or of a matching volume of placebo (n = 209). Each injection was given monthly, along with 12 sessions of low-intensity psychosocial intervention. Analysis was by intent-to-treat, and the primary outcome was the event rate of heavy drinking days.
Compared with placebo, 380 mg of long-acting naltrexone was associated with a 25% decrease in the event rate of heavy drinking days ( P = .03), and 190 mg of naltrexone was associated with a 17% decrease ( P = .07). Treatment effects were greater in men and in those with lead-in abstinence.
Discontinuation because of adverse events occurred in 14.1% of those assigned to 380 mg of naltrexone, in 6.7% of those assigned to 190 mg of naltrexone, and in 6.7% of those assigned to placebo. There was no evidence of hepatotoxicity. Overall, rate and time to treatment discontinuation were similar in all three groups.
"Long-acting naltrexone was well tolerated and resulted in reductions in heavy drinking among treatment-seeking alcohol-dependent patients during six months of therapy," the authors write. "These data indicate that long-acting naltrexone can be of benefit in the treatment of alcohol dependence."
Study limitations include the possibility that patients enrolled in this trial may have had more motivation for change than patients treated in traditional outpatient settings; lack of drinking data for dropouts once they left the study; and inability to address why the results differed in men and in women.
"Since no single treatment will reduce completely the risk of heavy drinking among all alcohol-dependent patients, we believe that an important clinical benefit of long-acting naltrexone is that it provides a firm basis for combination with other treatments, including psychotherapy, other medications, or both," the authors conclude. "Additional research is needed to determine the optimal duration of treatment with long-acting naltrexone, as well as indicators that treatment can be discontinued."
Alkermes funded this study and employs three of its authors. Some of the other authors report various financial arrangements with Bristol-Meyers Squibb, Alkermes, Oy ContrAl Pharma, Forest Laboratories, Wyeth-Ayerst, Drug Abuse Sciences, Ortho-McNeil Pharmaceuticals, Pfizer, DuPont, Lipha, Johnson & Johnson, AstraZeneca, Eli Lilly, Lipha-Merck-KGaA, Axis-Shield, and/or Titan.
JAMA. 2005;293:1617-1625
