Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse — DIAMA  

Alcoholism Clinical Trial

Official title: Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse

Status Completed

Clinical Trial Summary

Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference medication for preventing or treating AWS. The recommended average diazepam treatment duration is usually around one week, and this duration is generally not considered to impact the subsequent relapse rate in alcohol drinking.

However, several previous studies have found that patients experienced frequent anxious symptoms during the weeks following detoxification. Such symptoms may foster early relapse in alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late withdrawal symptoms.

The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one month can significantly reduce the cumulated relapse rate in alcohol drinking over the three following months.

Clinical Trial Description

• inclusion at Day 5 of the outpatient alcohol detoxification procedure

• randomization in two arms: 1) "10 day - diazepam"; and 2) "30 day - diazepam"

• tapering of diazepam over the 10 days following the beginning of the detoxification procedure in the first arm; tapering of diazepam over the 30 days following the beginning of the detoxification procedure in the second arm.

• 3-month-long follow-up after detoxification. Objective of maintaining abstinence from alcohol. No use of additional anticraving drug. Standardised psychotherapeutic support based on the BRENDA model.

• Longitudinal recording of alcohol consumption using the Alcohol Timeline Follow-Back method.

• Assessment of craving (Obsessive-Compulsive Drinking Scale) and anxiety (State-Trait Anxiety Inventory; Hamilton Anxiety Rating Scale) at Days 5 (baseline), 15, 30, 60 and 90 (final assessment). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Recurrence

• NCT number: NCT02242955
• Study type: Interventional
• Source: University Hospital, Lille
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Completion date: July 2016