A Clinical Trial on the Efficacy of tDCS) in Reducing Alcohol Consumption in Non-abstinent Patients (REDSTIM) (REDSTIM)

February 21, 2024 updated by: Centre Hospitalier Universitaire Dijon

A Randomized Double-blind Clinical Trial on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Reducing Alcohol Consumption in Non-abstinent Patients With Alcohol Use Disorder

The study evaluates the efficacy of 1 week of tDCS (5 sessions) placebo in reducing alcohol consumption within the 24 weeks following the treatment in non-abstinent patients with alcohol use disorders versus placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

340 patients are expected and randomized in two groups: 170 patients with active tDCS and 170 patients with placebo tDCS

Visit 1 : Patients will received one daily session (13:20:13) during 5 consecutive days: current flows continuously twice for 13min with a rest interval (no stimulation) of 20 min.

Visit 1 to 7 : Change from baseline to week 24 in Total Alcohol Consumption (TAC) and Number of Heavy Drinking Days (HDD) will be evaluated in each group.

Evaluation on alcohol consumption (daily drinking diary, alcohol craving and severity) and other assessments like mood, quality of life, safety.

The co-primary outcome of change from baseline in total alcohol consumption AND reduction in number of heavy drinking days at 6 months after treatment and its association with tDCS will be analyzed under the intention-to-treat principle using a mixed model repeated measures (8 times).

Study Type

Interventional

Enrollment (Actual)

339

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de DIJON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have signed and dated the informed consent form
  • Male and female patients over 18 years of age
  • Patients who meet at least two criteria for Alcohol Use Disorder as defined in the Diagnostic and statistical Manual of mental disorder (DSM-5)
  • Patients who are motivated to reduce their alcohol consumption
  • At least one attempt to achieve abstinence (unsuccessful or relapse) or to reduce alcohol consumption

Exclusion Criteria:

  • Breath-alcohol concentration > 0 milligrams per litre of exhaled air at randomization (visit 1)
  • < 6 heavy drinking days in the 4 weeks before randomization (European Medicines Agency, 2010; a day with alcohol consumption ≥ 60 g for men and ≥40 g for women)
  • An average alcohol consumption below medium risk level according to World health Organization (WHO) in the 4 weeks before screening (WHO, 2000; ≤40g/day for men; ≤20g/day for women),
  • More than 3-days abstinence prior to screening and randomization (screening visit and visit 1)
  • A Revised Clinical Institute Withdrawal Assessment for Alcohol score ≥ 10 (indicating the need for medication supported detoxification) at randomization (visit 1)
  • Concomitant treatment with disulfiram, acamprosate, topiramate, baclofen, naltrexone, and nalmefene (<1 month)
  • History of pre-delirium tremens and delirium tremens
  • DSM-5 substance use disorder other than alcohol or nicotine use disorder
  • Acute psychiatric disorders that have required hospitalisation and/or immediate adjustment of psychotropic medications
  • Major depression, as defined by Hamilton Depression (HDRS) scale greater than or equal to 24
  • Recent change in psychotropic medication (< 1 month)
  • Severe chronic psychiatric disorders including schizophrenia, paranoia and bipolar disorder type I and II
  • Advanced liver, kidney, cardiac, or pulmonary disease or other acute serious or unstable medical condition that would compromise patient's participation in the study according to physician's judgment
  • Contra-indications to tDCS: metal in the head, implanted brain medical devices
  • Women who are pregnant or lactating
  • Women of childbearing potential with a positive urine β-human chorionic gonadotrophin pregnancy test at randomization (visit 1)
  • Concurrent participation in other trial
  • Employees of the investigator or trial site
  • Patients protected by law
  • Persons who are not covered by national health insurance
  • Patients, in the opinion of the investigation, not able to complete the TLFB and to complete their daily alcohol consumption in a diary (derived from the TLFB) during the 3 months of the study.
  • Patients who refused to sign "safety" agreement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active tDCS group
Active tDCS
Device: Active tDCS
One daily session (13:20:13) : active current flows continuously twice for 13 minutes with a rest interval (no stimulation) of 20 min 5 sessions (once a week for 5 consecutive days)
Placebo Comparator: Placebo tDCS group
Placebo tDCS : Inactive tDCS
Device: Placebo tDCS
One daily session (13:20:13) : inactive current flows continuously twice for 13 with a rest interval (no stimulation) of 20 min 5 sessions (once a week for 5 consecutive days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to week 24 in Total Alcohol Consumption (TAC)
Time Frame: 24 weeks following the treatment

Baseline was defined as alcohol consumption during the 28 days before randomization (visit 1). Baseline will be determined using TLFB (alcohol Timeline Follow-Back), a validated method that retrospectively obtains estimates of daily drinking using a calendar.

TAC was defined as mean daily alcohol consumption over 28 days (in g/day)
24 weeks following the treatment
Change from baseline to week 24 in Number of Heavy Drinking Days (HDD).
Time Frame: 24 weeks following the treatment
HDD was defined as more than 60 grams of pure alcohol in men and 40 grams in women
24 weeks following the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with a significant categorical shift in World health organization (WHO) risk levels of drinking
Time Frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
low risk (Men≤40g/d ; Women≤20g/d), medium risk (Men≤60g/d; Women≤40g/d), high risk (Men≤100g/d; Women≤60g/d, very high risk (Men>100g/d; Women>60g/d; WHO, 2010)
Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Proportion of subjects with a 50%, 70% and 90% reduction in alcohol consumption as well as the proportion of patients achieving maintained abstinence (cumulative abstinence duration)
Time Frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Change in the level of alcohol dependence severity
Time Frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
measured by the Alcohol Dependence Scale (ADS)
Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Change in craving/urge to drink assessment
Time Frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
using Visual Analogue Scale (VAS) the Obsessive Compulsive Drinking Scale (OCDS)
Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Change in Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I)
Time Frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Number of patients with Adverse Events (AEs)
Time Frame: during the entire treatment period, and then for each 4-week period after the treatment up to week 24
during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Change in Quality of Life
Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment
SF 12
Change from baseline at week 4, week 12, and week 24 after the treatment
Change in validated biochemical alcohol consumption markers
Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment
Gamma Glutamyl transferase (GGT), Mean Corpuscular Volume (MCV), Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT) and Carbohydrate Deficient Transferrin (CDT%)
Change from baseline at week 4, week 12, and week 24 after the treatment
Change in scores for anxiety and depression scales
Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment
Hamilton Depression Rating Scale (HDRS-21)
Change from baseline at week 4, week 12, and week 24 after the treatment
For smokers: change in number of cigarettes smoked/day and craving for tobacco
Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment
Visual Analogue Scale (VAS), Tobacco Craving Questionnaire (TCQ),
Change from baseline at week 4, week 12, and week 24 after the treatment
Change in cognitive assessment
Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment
Montreal Cognitive Assessment (MOCA)
Change from baseline at week 4, week 12, and week 24 after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2015

Primary Completion (Actual)

December 23, 2021

Study Completion (Actual)

December 23, 2021

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimated)

July 22, 2015

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROJAK PHRC N 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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