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

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT02242955

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism	Drug: Diazepam	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AD = "as-usual diazepam" Diazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification).	Drug: Diazepam 40 mg per day.
Experimental: PD = "prolonged diazepam" Diazepam will be slowly tapered to be stopped at day 30	Drug: Diazepam 40 mg per day.

Arm

Intervention/Treatment

Active Comparator: AD = "as-usual diazepam"

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

Drug: Diazepam

40 mg per day.

Experimental: PD = "prolonged diazepam"

Diazepam will be slowly tapered to be stopped at day 30

Drug: Diazepam

40 mg per day.

Outcome Measures

Primary Outcome Measures

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

Occurrence of adverse events [Over the first 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).
Ratio of drinking days/heavy drinking days [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
Level of clinician-assessed anxiety [at 1 month; at 3 months]
Score of anxiety using the Hamilton Anxiety Rating Scale
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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