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

University Hospital, Lille

Status

Completed

Conditions

Alcoholism

Treatments

Drug: Diazepam

Study type

Interventional

Funder types

Other

Identifiers

NCT02242955

2011_44

2012-003336-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment

26 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

DSM-IV-Tr criteria for alcohol dependence
Diazepam-based outpatient detoxification procedure started 5 days prior to inclusion

Exclusion criteria

contraindication for outpatient detoxification
occurrence of delirium tremens or seizures during the pre-inclusion period
contraindication for using diazepam
any other DSM-IV-TR criteria for substance abuse or dependence in the preceding year (except from tobacco)
concurrent axis-I psychiatric disorder
concurrent neurological pathology or cognitive impairment
concurrent social risk, i.e., homelessness or social isolation
liver failure, cancer, or significant breathing disorder