Skip to main content
OpenTrials
Completed

NCT Number: NCT02242955

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcoholism Alcohol-Related Disorders Anxiety Disorders Chemically-Induced Disorders Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Addiction Medicine, Lille, France

Loading trial locations.

About this study

  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diazepam

Drug

40 mg per day.

Primary outcomes

  1. 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

  1. Occurrence of adverse events

    Time frame: Over the first month, at 3 months

  2. Rate of relapse in heavy drinking

    Time frame: 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).

  3. Ratio of drinking days/heavy drinking days

    Time frame: over the first month, at 3 months

  4. Level of self-reported anxiety

    Time frame: at 1 month; at 3 months

    Score of self-reported anxiety using the State-Trait Anxiety Inventory

  5. Level of clinician-assessed anxiety

    Time frame: at 1 month; at 3 months

    Score of anxiety using the Hamilton Anxiety Rating Scale

  6. Level of alcohol craving

    Time frame: at 1 month; at 3 months

    Level of alcohol craving using the Obsessive-Compulsive Drinking Scale

  7. Average weekly alcohol consumption

    Time frame: at 1 month; at 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: DIAMA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 17, 2014
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.