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

NCT ID: NCT02242955

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-07-31

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).

Conditions

Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AD = "as-usual diazepam"

Diazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification).

Group Type: ACTIVE_COMPARATOR

Diazepam

Intervention Type: DRUG

40 mg per day.

PD = "prolonged diazepam"

Diazepam will be slowly tapered to be stopped at day 30

Group Type: EXPERIMENTAL

Diazepam

Intervention Type: DRUG

40 mg per day.

Interventions

Diazepam

40 mg per day.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin ROLLAND, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Lille (CHU Lille), France

Locations

Department of Addiction Medicine

Lille, , France

Outpatient Addiction Center "CSAPA - Le Pari"

Lille, , France

Countries

France

Other Identifiers

2012-003336-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2011_44

Identifier Type: -

Identifier Source: org_study_id