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

NCT02505126 | Completed

• 1 other identifier: TROJAK PHRC N 2014
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholic Intoxication, Chronic

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  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

  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)

  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

  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

  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)

  Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24

Study Arms (2)

Active tDCS group

EXPERIMENTAL

Active tDCS

Device: Active tDCS

Placebo tDCS group

PLACEBO COMPARATOR

Placebo tDCS : Inactive tDCS

Device: Placebo tDCS

Interventions

Active tDCS DEVICE

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)

Active tDCS group

Placebo tDCS DEVICE

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)

Placebo tDCS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

Location

Related Publications (1)

• 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.

  PMID: 27188795 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 22, 2015
• Study Start: November 23, 2015
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

FR (1)