Thirty- Versus Ten-Day Diazepam Treatment for Alcohol Detoxification and a Comparison of Drinking Patterns, Craving, and Anxiety for up to 12 Weeks: A "Proof-of-Concept" Open-Label Randomized Controlled Trial.

Purpose: The aim of this study was to evaluate whether a prolonged detoxification treatment could decrease the relapse rate at 3 months after alcohol cessation in alcohol-dependent individuals through decreasing the levels of postdetoxification craving and anxiety.

Methods: Twenty-six adult patients with alcohol dependence (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) who began an outpatient alcohol cessation program with an initial drinking goal of abstinence were enrolled in a 3-month, parallel, randomized (1:1 ratio), controlled, open-label, pilot trial. Participants were randomized to receive a detoxification treatment of diazepam with a duration of 30 (n = 12) or 10 days (n = 14). All participants received BRENDA-based psychotherapy during follow-up.

Results: No significant between-group difference in relapse to any drinking was found at 3 months (P = 0.20). However, relapse to any heavy drinking at 3 months and regular drinking or heavy drinking during follow-up were significantly lower in the 30-day diazepam group (P = 0.009, P = 0.049, and P = 0.004, respectively). These differences were corroborated by significant differences in the alcohol-specific biological marker carbohydrate deficient transferrin at 3 months. Participants in the 30-day diazepam group also displayed significantly lower scores for alcohol craving (P = 0.007), self-reported anxiety (P = 0.024), and clinician-assessed anxiety (P = 0.002) throughout the follow-up. No serious adverse event was reported during the study.

Conclusion: This study provides an evidence-based rationale for a double-blind, randomized, placebo-controlled trial to confirm the efficacy of such a procedure on short-term and mid-/long-term drinking outcomes after alcohol cessation in alcohol-dependent individuals.