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

Not Applicable

Completed

• Conditions: Alcoholism
• Interventions: Drug: Diazepam

• Registration Number: NCT02242955
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed 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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-17
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD = "prolonged diazepam"	Diazepam	Diazepam will be slowly tapered to be stopped at day 30
AD = "as-usual diazepam"	Diazepam	Diazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification).

Primary Outcome Measures

Name	Time	Method
Rate of relapse in alcohol drinking	at 3 months	Proportion of patients who will have reported any alcohol drinking over the three months following the beginning of the detoxification procedure (using the alcohol timeline follow-back method).

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse events	Over the first month, at 3 months
Level of self-reported anxiety	at 1 month; at 3 months	Score of self-reported anxiety using the State-Trait Anxiety Inventory
Ratio of drinking days/heavy drinking days	over the first month, at 3 months
Level of alcohol craving	at 1 month; at 3 months	Level of alcohol craving using the Obsessive-Compulsive Drinking Scale
Average weekly alcohol consumption	at 1 month; at 3 months
Rate of relapse in heavy drinking	at 1 month; at 3 months	Proportion of patients who will have reported at least one heavy drinking day, i.e., ≥ 50 g of alcohol in a day, over the first month and the three month following the beginning of the detoxification procedure (using the alcohol timeline follow-back method).
Level of clinician-assessed anxiety	at 1 month; at 3 months	Score of anxiety using the Hamilton Anxiety Rating Scale

Trial Locations

Locations (2)

Department of Addiction Medicine; 🇫🇷 Lille, France

Outpatient Addiction Center "CSAPA - Le Pari"; 🇫🇷 Lille, France