Results from a randomized controlled trial of zonisamide in the treatment of alcohol use disorder.
Autor: | Farchione TJ; Center for Anxiety and Related Disorders, Boston University, Boston, MA, USA. Electronic address: tfarchio@bu.edu., Long LJ; Center for Anxiety and Related Disorders, Boston University, Boston, MA, USA., Gallagher MW; Department of Psychology, Texas Institute for Measurement, Evaluation and Statistics, University of Houston, Houston, TX, USA., Spencer-Laitt D; Center for Anxiety and Related Disorders, Boston University, Boston, MA, USA., Torre M; Center for Anxiety and Related Disorders, Boston University, Boston, MA, USA., Woodard LS; Center for Anxiety and Related Disorders, Boston University, Boston, MA, USA., Curreri AJ; Center for Anxiety and Related Disorders, Boston University, Boston, MA, USA., Brown B; Center for Anxiety and Related Disorders, Boston University, Boston, MA, USA., Ross M; Center for Anxiety and Related Disorders, Boston University, Boston, MA, USA., Barlow DH; Center for Anxiety and Related Disorders, Boston University, Boston, MA, USA. |
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Jazyk: | angličtina |
Zdroj: | Journal of psychiatric research [J Psychiatr Res] 2024 Nov; Vol. 179, pp. 182-190. Date of Electronic Publication: 2024 Sep 10. |
DOI: | 10.1016/j.jpsychires.2024.08.044 |
Abstrakt: | There is preliminary evidence that the anticonvulsant medication Zonisamide (ZON) may be an effective, well-tolerated treatment for alcohol use disorder (AUD). However, further evaluation of its efficacy for treating patients with AUD is needed, and much remains unknown about ZON's therapeutic mechanisms. The present study aimed to evaluate the efficacy and tolerability of ZON in a double-blind, placebo-controlled, randomized trial. Eighty-one adults (ages 21-65) diagnosed with AUD were randomly assigned to receive either ZON (at a target dose of 400 mg/d) or a pill placebo over 12 weeks, followed by a two-week taper. All participants also received a computerized alcohol reduction program, Take Control (TC). Primary drinking outcomes were average daily drinks, percentage drinking days, and percentage heavy drinking days. Further, we evaluated changes in AUD clinical severity and performance on neuropsychological measures. For both groups, drinking outcomes generally decreased, as did AUD clinical severity, though group differences were not statistically significant. Neuropsychological testing performance was similar for both groups at baseline; however, at post-treatment, participants in the ZON group demonstrated poorer working memory and lower performance on verbal fluency tests compared to the placebo group, and these differences were statistically significant with moderate-large effect sizes. One serious adverse event was reported among individuals receiving ZON. Study findings indicate that ZON combined with TC does not demonstrate superior effectiveness for reducing average daily drinks in this clinical sample with principal AUD compared to placebo and TC, and treatment with ZON may be associated with reduced neurocognitive performance over time. Competing Interests: Declaration of competing interest Todd J. Farchione: Dr. Farchione receives royalties from Oxford University Press and research funding related to the reported work from the National Institute of Alcohol Abuse. He also received consulting (personal) fees from the MacArthur Foundation, the National Center of Neurology and Psychiatry in Japan, Brightside Health, Tage S.R.L., Allegheny Health Network, and Grupo Pacifico outside the submitted work. Laura J. Long: None. Matthew W. Gallagher: Dr. Gallagher received research funding from the National Institute of Alcohol and Alcohol Abuse during the conduct of the study. Daniella Spencer-Laitt: None. Marie Torre: None. Lauren S. Woodard: None. Andrew J. Curreri: None. Bonnie Brown: None. Margaret Ross: None. David H. Barlow: Dr. Barlow receives royalties for books and treatment manuals from Oxford University Press, Guilford Publications Inc., Cengage Learning, and Pearson Publishing. Grant monies for various projects come from the National Institute of Mental Health, the National Institute of Alcohol and Alcohol Abuse, and Colciencias (Government of Columbia Initiative for Science, Technology, and Health Innovation). Consulting and honoraria during the past several years have come from the Agency for Healthcare Research and Quality, the Foundation for Informed Medical Decision Making, the Department of Defense, the Renfrew Center, the Chinese University of Hong Kong, Universidad Católica de Santa Maria (Arequipa, Peru), New Zealand Psychological Association, Hebrew University of Jerusalem, Mayo Clinic, and various American Universities. (Copyright © 2024 Elsevier Ltd. All rights reserved.) |
Databáze: | MEDLINE |
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