Alcoholism
Conditions
Keywords
Alcohol-dependence, Relapse, Detoxification, Diazepam, Benzodiazepines, Anxiety
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).
Interventions
DRUGDiazepam
40 mg per day.
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORBenjamin ROLLAND, MD, PhD
University Hospital of Lille (CHU Lille), France
Outcome results
None listed