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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: Diazepam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  | Over the first month, at 3 months | 
| 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 | 
| Ratio of drinking days/heavy drinking days |  | over the first month, at 3 months | 
| Level of self-reported anxiety | Score of self-reported anxiety using the State-Trait Anxiety Inventory | at 1 month; at 3 months | 
| Level of clinician-assessed anxiety | Score of anxiety using the Hamilton Anxiety Rating Scale | at 1 month; at 3 months | 
| Level of alcohol craving | Level of alcohol craving using the Obsessive-Compulsive Drinking Scale | at 1 month; at 3 months | 
| Average weekly alcohol consumption |  | at 1 month; at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol-dependence, Relapse, Detoxification, Diazepam, Benzodiazepines, Anxiety