Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Locations
- 4
- Primary Endpoint
- Rate of relapse in alcohol drinking
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
PD = "prolonged diazepam"
Diazepam will be slowly tapered to be stopped at day 30
Intervention: Diazepam (Drug)
AD = "as-usual diazepam"
Diazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification).
Intervention: Diazepam (Drug)
Outcomes
Primary Outcomes
Rate of relapse in alcohol drinking
Time Frame: 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 Outcomes
- Occurrence of adverse events(Over the first month, at 3 months)
- Level of self-reported anxiety(at 1 month; at 3 months)
- Ratio of drinking days/heavy drinking days(over the first month, at 3 months)
- Level of alcohol craving(at 1 month; at 3 months)
- Average weekly alcohol consumption(at 1 month; at 3 months)
- Rate of relapse in heavy drinking(at 1 month; at 3 months)
- Level of clinician-assessed anxiety(at 1 month; at 3 months)