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Divalproex Sodium in Alcohol Withdrawal: A Randomized Double‐Blind Placebo‐Controlled Clinical Trial
Author(s) -
Reoux Joseph P.,
Saxon Andrew J.,
Malte Carol A.,
Baer John S.,
Sloan Kevin L.
Publication year - 2001
Publication title -
alcoholism: clinical and experimental research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.267
H-Index - 153
eISSN - 1530-0277
pISSN - 0145-6008
DOI - 10.1111/j.1530-0277.2001.tb02354.x
Subject(s) - divalproex , oxazepam , placebo , anesthesia , randomized controlled trial , medicine , benzodiazepine , alcohol dependence , anticonvulsant , alcohol , psychology , psychiatry , bipolar disorder , chemistry , epilepsy , lithium (medication) , receptor , alternative medicine , mania , biochemistry , pathology
Background: Divalproex sodium, an anticonvulsant and antikindling agent and γ‐aminobutyric acid enhancer, has been proposed as an alternative to benzodiazepines for treating alcohol withdrawal. This study reports on a randomized, double‐blind, placebo‐controlled trial of divalproex sodium in acute alcohol withdrawal. Methods: Thirty‐six hospitalized patients experiencing moderate alcohol withdrawal as measured by a score of at least 10 on the revised Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA‐Ar) were randomized to receive either divalproex sodium 500 mg three times per day for 7 days or matched placebo in a double‐blind manner. All subjects received a baseline dose of oxazepam and had additional oxazepam available as a rescue medication in accordance with a standard, symptom‐triggered detoxification protocol. Mean total milligrams of oxazepam received, progression of withdrawal symptoms, psychological distress as measured by the Symptom Checklist‐90, side effects, and adverse outcomes were compared between groups. Results: Use of divalproex sodium resulted in less use of oxazepam ( p < 0.033). Group differences seemed primarily driven by those subjects who experienced symptoms above threshold level (CIWA‐Ar ≥10) after 12 hr. The progression in severity of withdrawal symptoms (increase in CIWA‐Ar above baseline) was also significantly greater in the placebo group ( p < 0.05). Conclusions: This placebo‐controlled pilot study suggests that divalproex sodium significantly affects the course of acute alcohol withdrawal and reduces the need for treatment with a benzodiazepine. A more aggressive loading dose strategy may demonstrate a more robust or earlier response.