NCT02242955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 22, 2026

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

September 15, 2014

Last Update Submit

April 17, 2026

Conditions

Alcoholism

Keywords

Alcohol-dependenceRelapseDetoxificationDiazepamBenzodiazepinesAnxiety

Outcome Measures

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).

    at 3 months

Secondary Outcomes (7)

  • Occurrence of adverse events

    Over the first month, at 3 months

  • Rate of relapse in heavy drinking

    at 1 month; at 3 months

  • 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

  • Level of clinician-assessed anxiety

    at 1 month; at 3 months

  • +2 more secondary outcomes

Study Arms (2)

AD = "as-usual diazepam"

ACTIVE COMPARATOR

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

Drug: Diazepam

PD = "prolonged diazepam"

EXPERIMENTAL

Diazepam will be slowly tapered to be stopped at day 30

Drug: Diazepam

Interventions

DiazepamDRUG

40 mg per day.

AD = "as-usual diazepam"PD = "prolonged diazepam"

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV-Tr criteria for alcohol dependence

You may not qualify if:

  • contraindication for outpatient detoxification
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Addiction Medicine

Lille, 59037, France

Location

Outpatient Addiction Center "CSAPA - Le Pari"

Lille, 59037, France

Location

Related Publications (1)

  • 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.

    PMID: 28984747RESULT

MeSH Terms

Conditions

AlcoholismRecurrenceAnxiety Disorders

Interventions

Diazepam

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Benjamin ROLLAND, MD, PhD

    University Hospital of Lille (CHU Lille), France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 17, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 22, 2026

Record last verified: 2016-09

Locations

FR(2)