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

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.

Study Overview

• Status: Completed
• Conditions: Alcoholism
• Intervention / Treatment: Drug: Diazepam

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AD = "as-usual diazepam"; Diazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification).	Drug: Diazepam; 40 mg per day.
Experimental: PD = "prolonged diazepam"; Diazepam will be slowly tapered to be stopped at day 30	Drug: Diazepam; 40 mg per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events		Over the first month, at 3 months
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).	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	Score of self-reported anxiety using the State-Trait Anxiety Inventory	at 1 month; at 3 months
Level of clinician-assessed anxiety	Score of anxiety using the Hamilton Anxiety Rating Scale	at 1 month; at 3 months
Level of alcohol craving	Level of alcohol craving using the Obsessive-Compulsive Drinking Scale	at 1 month; at 3 months
Average weekly alcohol consumption		at 1 month; at 3 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Benjamin ROLLAND, MD, PhD, University Hospital of Lille (CHU Lille), France

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: September 15, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 17, 2014

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Anxiety; Benzodiazepines; Relapse; Diazepam; Detoxification; Alcohol-dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Disease Attributes; Alcoholism; Recurrence; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diazepam
• Other Study ID Numbers: 2011_44; 2012-003336-23 (EudraCT Number)