A multi-site dose ranging study of nalmefene in the treatment of alcohol dependence

Raymond F. Anton, Helen Pettinati, Allen Zweben, Henry R. Kranzler, Bankole Johnson, Michael J. Bohn, Mary E. McCaul, Robert Anthenelli, Ihsan Salloum, Gantt Galloway, James Garbutt, Robert Swift, David Gastfriend, Antero Kallio, Sakari Karhuvaara

Research output: Contribution to journalArticle

90 Scopus citations

Abstract

The opiate antagonist nalmefene has been shown in 2 single-site studies to reduce alcohol consumption and relapse drinking in alcohol-dependent individuals. This safety and preliminary multisite efficacy study evaluated 3 doses of nalmefene (5, 20, or 40 mg) in a double-blind comparison to placebo over a 12-week treatment period in 270 recently abstinent outpatient alcohol-dependent individuals. Participants concomitantly received 4 sessions of a motivational enhancement therapy (with a medication compliance component) delivered from trained counselors. Although more subjects in the active medication groups terminated the study early secondary to adverse events, the rates did not differ significantly from that of placebo. The 20-mg/d group experienced more insomnia, dizziness, and confusion, while the 5-mg group also had more dizziness and the 40-mg group had more nausea than the placebo group. Most of these symptoms were mild and improved over time. Although all subjects had a reduction in heavy drinking days, craving, γ-glutamyl transferase, and carbohydrate-deficient transferrin concentrations over the course of the study, there was no difference between the active medication and placebo groups on these measures. The time to first heavy drinking day was also not significantly different between the placebo and the active treatment groups. This relatively small multisite trial showed that nalmefene was reasonably well tolerated in recently abstinent alcoholics. However, possibly because of variation among the sites or the comparatively small sample size, there was no evidence of superior efficacy outcomes with nalmefene treatment.

Original languageEnglish (US)
Pages (from-to)421-428
Number of pages8
JournalJournal of clinical psychopharmacology
Volume24
Issue number4
DOIs
StatePublished - Aug 1 2004
Externally publishedYes

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

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    Anton, R. F., Pettinati, H., Zweben, A., Kranzler, H. R., Johnson, B., Bohn, M. J., McCaul, M. E., Anthenelli, R., Salloum, I., Galloway, G., Garbutt, J., Swift, R., Gastfriend, D., Kallio, A., & Karhuvaara, S. (2004). A multi-site dose ranging study of nalmefene in the treatment of alcohol dependence. Journal of clinical psychopharmacology, 24(4), 421-428. https://doi.org/10.1097/01.jcp.0000130555.63254.73