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

Alcoholism Clinical Trial

— DIAMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242955
• Other study ID #: 2011_44
• Secondary ID: 2012-003336-23
• Status: Completed
• Phase: N/A
• First received: September 15, 2014
• Last updated: September 14, 2016
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Alcoholism
• Recurrence

Intervention

Drug:
• Diazepam
40 mg per day.

Locations

Country	Name	City	State
France	Department of Addiction Medicine	Lille
France	Outpatient Addiction Center "CSAPA - Le Pari"	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of relapse in alcohol drinking	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).	at 3 months	No
Secondary	Occurrence of adverse events		Over the first month, at 3 months	Yes
Secondary	Rate of relapse in heavy drinking	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).	at 1 month; at 3 months	No
Secondary	Ratio of drinking days/heavy drinking days		over the first month, at 3 months	No
Secondary	Level of self-reported anxiety	Score of self-reported anxiety using the State-Trait Anxiety Inventory	at 1 month; at 3 months	No
Secondary	Level of clinician-assessed anxiety	Score of anxiety using the Hamilton Anxiety Rating Scale	at 1 month; at 3 months	No
Secondary	Level of alcohol craving	Level of alcohol craving using the Obsessive-Compulsive Drinking Scale	at 1 month; at 3 months	No
Secondary	Average weekly alcohol consumption		at 1 month; at 3 months	No