Clinical trial NCT02242955: Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse
Official title: Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Keywords: Alcohol-dependence
Relapse
Detoxification
Diazepam
Benzodiazepines
Anxiety
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Rate of relapse in alcohol drinking
timeFrame: at 3 months
Secondary outcomes:
measure: Occurrence of adverse events
timeFrame: Over the first month, at 3 months
measure: Rate of relapse in heavy drinking
timeFrame: at 1 month; at 3 months
measure: Ratio of drinking days/heavy drinking days
timeFrame: over the first month, at 3 months
measure: Level of self-reported anxiety
timeFrame: at 1 month; at 3 months
measure: Level of clinician-assessed anxiety
timeFrame: at 1 month; at 3 months
measure: Level of alcohol craving
timeFrame: at 1 month; at 3 months
measure: Average weekly alcohol consumption
timeFrame: at 1 month; at 3 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Department of Addiction Medicine
city: Lille
country: France
facility: Outpatient Addiction Center "CSAPA - Le Pari"
Study officials:
affiliation: University Hospital of Lille (CHU Lille), France
name: Benjamin ROLLAND, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: