HD-tACS for Alcohol Use Disorder
ConditionAlcohol Use Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanghai Mental Health Center
About this trial
This study aims to systematically explore the effectiveness of accelerated HD-tACS in treating AUD, particularly its efficacy in reducing alcohol craving and preventing relapse in AUD patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age range: 18-55 years old, gender not restricted;
Meets the DSM-5 diagnostic criteria for alcohol use disorder (moderate to severe);
AUDIT score ≥ 16;
Baseline score after alcohol cue-induced stimulation is ≥ 3;
Disqualifiers
Currently, there are other substance use disorders (except nicotine);
Currently, there are schizophrenia, bipolar disorder or other severe psychotic disorders;
Has a history of epilepsy or family history of epilepsy;
Has a history of brain trauma, brain surgery or intracranial metal implants;
Trial design
Design model
Parallel
Treatments tested in this trial
HD-tACS
DeviceThe stimulation parameters are 40Hz and 2mA. The stimulation protocol is 20 minutes per session, 3 times per day, for a total of 10 consecutive days.
Sham HD-tACS
DeviceThe stimulation parameters are 40Hz and 2mA. The stimulation protocol is 20 minutes per session, 3 times per day, for a total of 10 consecutive days. At the commencement and conclusion of each therapeutic session, a 30-second ramp-up stimulation and a 30-second ramp-down stimulation (totaling 60 seconds) are administered, respectively, while the current output of the device is maintained at zero throughout the intervening interval.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: HD-tACS groupExperimental treatment 1 intervention
Group B: Sham HD-tACS groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change of Craving
Visual Analog Scale, range 0-100 point, the higher the score, the more one wants drugs.
Time frame
baseline; The 2nd, 4th, 6th, 8th and 10th days during the intervention period; 4 weeks after treatment; 12 weeks after treatmentSecondary outcomes
1
impulsivity
Stop Single Task
Time frame
baseline; 1 day after the treatment was completed2
Negative reinforcement learning task
The negative reinforcement learning task was adopted to evaluate the patients' avoidance-avoidance behaviors and learning. By calculating and modeling, the avoidance-avoidance behavior bias (active avoidance bias ) and the learning rates based on different feedback: learning from successfully avoiding the aversive stimulus; learning from experiencing the aversive stimulus) were constructed.
Time frame
baseline; 1 day after treatment was completed3
Changes in Reward Learning
Reward Learning Task
Time frame
baseline; 1 day after treatment was completed4
Compulsory drinking
The Obsessive Compulsive Drinking Scale (OCDS) assesses compulsive thoughts and impulsive behaviors related to alcohol consumption. It consists of 14 items, each rated on a 5-point scale from 0 to 4. Scores ranging from 0 to 14 indicate almost no compulsive drinking characteristics, 15 to 28 indicate obvious compulsive thoughts or impulses, and scores above 29 indicate a significant compulsive drinking pattern with a high risk of relapse.
Time frame
baseline; 1 day after treatment was completedSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: