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CompletedNCT02242955DIAMAUpdated Apr 22, 2026

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

An interventional study of Diazepam in Alcoholism, sponsored by University Hospital, Lille. Completed at 2 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Alcoholism

Keywords

  • Alcohol-dependence
  • Relapse
  • Detoxification
  • Diazepam
  • Benzodiazepines
  • Anxiety
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 26 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    AD = "as-usual diazepam"

    Diazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification).

    Drug: Diazepam

  • Experimental
    PD = "prolonged diazepam"

    Diazepam will be slowly tapered to be stopped at day 30

    Drug: Diazepam

Interventions

  • DrugDiazepam

    40 mg per day.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: at 3 months

Secondary outcomes

  1. Occurrence of adverse events

    Time frame: Over the first month, at 3 months

  2. 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).

    Time frame: at 1 month; at 3 months

  3. Ratio of drinking days/heavy drinking days

    Time frame: over the first month, at 3 months

  4. Level of self-reported anxiety

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

    Time frame: at 1 month; at 3 months

  5. Level of clinician-assessed anxiety

    Score of anxiety using the Hamilton Anxiety Rating Scale

    Time frame: at 1 month; at 3 months

  6. Level of alcohol craving

    Level of alcohol craving using the Obsessive-Compulsive Drinking Scale

    Time frame: at 1 month; at 3 months

  7. Average weekly alcohol consumption

    Time frame: at 1 month; at 3 months

07

Study locations

2 sites
  • Department of Addiction Medicine
    Lille, 59037, France
  • Outpatient Addiction Center "CSAPA - Le Pari"
    Lille, 59037, France
08

References and documents

Publications

  • Simioni N, Labreuche J, Behal H, Cottencin O, Rolland B. Thirty- Versus Ten-Day Diazepam Treatment for Alcohol Detoxification and a Comparison of Drinking Patterns, Craving, and Anxiety for up to 12 Weeks: A "Proof-of-Concept" Open-Label Randomized Controlled Trial. J Clin Psychopharmacol. 2017 Dec;37(6):722-728. doi: 10.1097/JCP.0000000000000786. PubMed 28984747 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02242955
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Sep 17, 2014
Start date
Jul 2014
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Apr 22, 2026

Study contacts

Benjamin ROLLAND, MD, PhD
principal investigator · University Hospital of Lille (CHU Lille), France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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