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

Primary Purpose

Alcoholic Intoxication, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Active tDCS
Placebo tDCS
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Intoxication, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de DIJONRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active tDCS group

Placebo tDCS group

Arm Description

Active tDCS

Placebo tDCS : Inactive tDCS

Outcomes

Primary Outcome Measures

Change from baseline to week 24 in Total Alcohol Consumption (TAC)
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)
Change from baseline to week 24 in Number of Heavy Drinking Days (HDD).
HDD was defined as more than 60 grams of pure alcohol in men and 40 grams in women

Secondary Outcome Measures

Proportion of subjects with a significant categorical shift in World health organization (WHO) risk levels of drinking
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)
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)
Change in the level of alcohol dependence severity
measured by the Alcohol Dependence Scale (ADS)
Change in craving/urge to drink assessment
using Visual Analogue Scale (VAS) the Obsessive Compulsive Drinking Scale (OCDS)
Change in Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I)
Number of patients with Adverse Events (AEs)
Change in Quality of Life
SF 12
Change in validated biochemical alcohol consumption markers
Gamma Glutamyl transferase (GGT), Mean Corpuscular Volume (MCV), Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT) and Carbohydrate Deficient Transferrin (CDT%)
Change in scores for anxiety and depression scales
Hamilton Depression Rating Scale (HDRS-21)
For smokers: change in number of cigarettes smoked/day and craving for tobacco
Visual Analogue Scale (VAS), Tobacco Craving Questionnaire (TCQ),
Change in cognitive assessment
Montreal Cognitive Assessment (MOCA)

Full Information

First Posted
July 15, 2015
Last Updated
December 12, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT02505126
Brief Title
A Clinical Trial on the Efficacy of tDCS) in Reducing Alcohol Consumption in Non-abstinent Patients (REDSTIM)
Acronym
REDSTIM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 23, 2015 (Actual)
Primary Completion Date
November 22, 2022 (Anticipated)
Study Completion Date
November 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Intoxication, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS group
Arm Type
Experimental
Arm Description
Active tDCS
Arm Title
Placebo tDCS group
Arm Type
Placebo Comparator
Arm Description
Placebo tDCS : Inactive tDCS
Intervention Type
Device
Intervention Name(s)
Active tDCS
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Placebo tDCS
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change from baseline to week 24 in Total Alcohol Consumption (TAC)
Description
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)
Time Frame
24 weeks following the treatment
Title
Change from baseline to week 24 in Number of Heavy Drinking Days (HDD).
Description
HDD was defined as more than 60 grams of pure alcohol in men and 40 grams in women
Time Frame
24 weeks following the treatment
Secondary Outcome Measure Information:
Title
Proportion of subjects with a significant categorical shift in World health organization (WHO) risk levels of drinking
Description
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)
Time Frame
Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Title
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
Title
Change in the level of alcohol dependence severity
Description
measured by the Alcohol Dependence Scale (ADS)
Time Frame
Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Title
Change in craving/urge to drink assessment
Description
using Visual Analogue Scale (VAS) the Obsessive Compulsive Drinking Scale (OCDS)
Time Frame
Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Title
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
Title
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
Title
Change in Quality of Life
Description
SF 12
Time Frame
Change from baseline at week 4, week 12, and week 24 after the treatment
Title
Change in validated biochemical alcohol consumption markers
Description
Gamma Glutamyl transferase (GGT), Mean Corpuscular Volume (MCV), Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT) and Carbohydrate Deficient Transferrin (CDT%)
Time Frame
Change from baseline at week 4, week 12, and week 24 after the treatment
Title
Change in scores for anxiety and depression scales
Description
Hamilton Depression Rating Scale (HDRS-21)
Time Frame
Change from baseline at week 4, week 12, and week 24 after the treatment
Title
For smokers: change in number of cigarettes smoked/day and craving for tobacco
Description
Visual Analogue Scale (VAS), Tobacco Craving Questionnaire (TCQ),
Time Frame
Change from baseline at week 4, week 12, and week 24 after the treatment
Title
Change in cognitive assessment
Description
Montreal Cognitive Assessment (MOCA)
Time Frame
Change from baseline at week 4, week 12, and week 24 after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benoît TROJAK, Doctor
Phone
33(3)80 29 37 69
Email
benoit.trojak@chu-dijon.fr
Facility Information:
Facility Name
CHU de DIJON
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoît TROJAK
Email
benoît.trojak@chu-dijon.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
27188795
Citation
Trojak B, Soudry-Faure A, Abello N, Carpentier M, Jonval L, Allard C, Sabsevari F, Blaise E, Ponavoy E, Bonin B, Meille V, Chauvet-Gelinier JC. Efficacy of transcranial direct current stimulation (tDCS) in reducing consumption in patients with alcohol use disorders: study protocol for a randomized controlled trial. Trials. 2016 May 17;17(1):250. doi: 10.1186/s13063-016-1363-8.
Results Reference
derived

Learn more about this trial

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

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