NCT02505126

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 339 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Alcoholic Intoxication, Chronic

Interventions

Type	Name	Description
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)
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)

Timeline

• Start date: 2015-11-23
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2015-07-22
• Last updated: 2024-02-22

Locations

1 site across 1 country: France