Alcoholic Intoxication, ChronicREDSTIMNCT02505126
A Clinical Trial on the Efficacy of tDCS) in Reducing Alcohol Consumption in Non-abstinent Patients (REDSTIM)
A study testing Active tDCS in people with Alcoholic Intoxication, Chronic, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Intoxication, Chronic
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 339 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2015to 23 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Alcoholic Intoxication, Chronic
- Being tested
- Active tDCS, Placebo tDCS
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
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 tDCSDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS group | Experimental | Active tDCS Receives: Device: Active tDCS |
| Placebo tDCS group | Placebo comparator | Placebo tDCS : Inactive tDCS Receives: Device: Placebo tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 weeks following the treatment
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
Measured: 24 weeks following the treatment
Secondary outcomes (11)
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)
Measured: 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)
Measured: 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
measured by the Alcohol Dependence Scale (ADS)
Measured: 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
using Visual Analogue Scale (VAS) the Obsessive Compulsive Drinking Scale (OCDS)
Measured: 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)
Measured: 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)
Measured: during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Change in Quality of Life
SF 12
Measured: Change from baseline at week 4, week 12, and week 24 after the treatment
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%)
Measured: Change from baseline at week 4, week 12, and week 24 after the treatment
Change in scores for anxiety and depression scales
Hamilton Depression Rating Scale (HDRS-21)
Measured: 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
Visual Analogue Scale (VAS), Tobacco Craving Questionnaire (TCQ),
Measured: Change from baseline at week 4, week 12, and week 24 after the treatment
Change in cognitive assessment
Montreal Cognitive Assessment (MOCA)
Measured: Change from baseline at week 4, week 12, and week 24 after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study start23 Nov 2015
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcoholic Intoxication, ChronicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505126
- Sponsor's protocol ID
- TROJAK PHRC N 2014
- Acronym
- REDSTIM
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2015
- Last updated
- 26 Oct 2026
- Results posted
- No
Publications
Trojak B, Sauvaget A, El Hage W, Wallenhorst T, Rolland B, Nubukpo P, Harika-Germaneau G, Szekely D, Giustiniani J, Auriacombe M, Brousse G, Guillaume S, Bubrovszky M, Petit B, Cabelguen C, El Ayoubi H, Rankin S, Soudry-Faure A, Goueslard K, Demina A. Efficacy and safety of transcranial direct current stimulation in alcohol use disorder: A randomized controlled triple-blind trial. Addiction. 2026 Aug;121(8):2141-2153. doi: 10.1111/add.70461. Epub 2026 May 6.
PubMed 42091052Trojak 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.
PubMed 27188795
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02505126
- Acronym / sponsor ID
- REDSTIM / TROJAK PHRC N 2014
- Conditions
- Alcoholic Intoxication, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS group | Experimental | Device: Active tDCSActive tDCS |
| Placebo tDCS group | Placebo comparator | Device: Placebo tDCSPlacebo tDCS : Inactive tDCS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSOne 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) | Device | Active tDCS group |
| Placebo tDCSOne 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) | Device | Placebo tDCS group |
Primary outcome
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)
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
11 secondary outcomes
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
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 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
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
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
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
Change in Quality of Life
Time frame: 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
Change in scores for anxiety and depression scales
Time frame: 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
Change in cognitive assessment
Time frame: Change from baseline at week 4, week 12, and week 24 after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Results publication: PubMed 42091052Trojak B, Sauvaget A, El Hage W, Wallenhorst T, Rolland B, Nubukpo P, Harika-Germaneau G, Szekely D, Giustiniani J, Auriacombe M, Brousse G, Guillaume S, Bubrovszky M, Petit B, Cabelguen C, El Ayoubi H, Rankin S, Soudry-Faure A, Goueslard K, Demina A. Efficacy and safety of transcranial direct current stimulation in alcohol use disorder: A randomized controlled triple-blind trial. Addiction. 2026 Aug;121(8):2141-2153. doi: 10.1111/add.70461. Epub 2026 May 6.
- Derived from this study: PubMed 27188795Trojak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Alcoholic Intoxication, Chronic, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 24 in Total Alcohol Consumption (TAC) (time frame: 24 weeks following the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505126, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.