Alcohol Use Disorder
Conditions
Keywords
alcohol use disorder
Brief summary
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.
Detailed description
This study conducted a multi-center randomized clinical controlled trial among individuals with alcohol use disorders, aiming to verify the effectiveness of accelerated HD-tACS in targeting the dorsolateral prefrontal cortex for the treatment of AUD. In particular, it aimed to assess the efficacy of accelerated HD-tACS in reducing alcohol craving and reducing relapse. Eligible patients were randomly divided into the accelerated HD-tACS group and the sham stimulation group in a 1:1 ratio. Clinical and electroencephalogram data were collected at baseline and after the intervention. Additionally, a follow-up assessment of alcohol consumption was conducted for all participants after the intervention ended.
Interventions
DEVICEHD-tACS
The 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.
DEVICESham HD-tACS
The 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.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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; * Completed detoxification treatment before enrollment (moderate to severe), with detoxification duration of ≥ 7 days and ≤ 90 days; * Has a primary school education or above, and can understand and complete the research assessment; * Voluntarily participated in the study and signed the informed consent form.
Exclusion criteria
* 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; * Has received electroconvulsive therapy (ECT), transcranial electrical/magnetic/ultrasound stimulation within the past 6 months; * Pregnant or lactating women; * Other situations that the researchers consider unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Craving | baseline; The 2nd, 4th, 6th, 8th and 10th days during the intervention period; 4 weeks after treatment; 12 weeks after treatment | Visual Analog Scale, range 0-100 point, the higher the score, the more one wants drugs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compulsory drinking | baseline; 1 day after treatment was completed | 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. |
| impulsivity | baseline; 1 day after the treatment was completed | Stop Single Task |
| Negative reinforcement learning task | baseline; 1 day after treatment was completed | 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. |
| Depressive state | baseline; 1 day after treatment was completed | The depression assessment was conducted using the Patient Health Questionnaire - 9 (PHQ-9), which consists of 9 items, each representing a different aspect of depressive symptoms. Each item is scored on a 4-point scale. 0-4 points indicate no depressive symptoms, 5-9 points represent mild depression, 10-14 points indicate moderate depression, and scores above 15 indicate severe depression. |
| Anxiety state | baseline; 1 day after treatment was completed; | The anxiety assessment was conducted using the Generalized Anxiety Disorder - 7 (GAD-7) self-rating scale. The core statistical indicator of this scale is the total score. The higher the score, the more severe the anxiety. A total score of 0-4 indicates no anxiety or the anxiety level is not clinically significant; a score of 5-9 represents mild anxiety; a score of 10-14 indicates moderate anxiety; and a score of 15 or above indicates severe anxiety. |
| Sleeping conditions | baseline; 1 day after the treatment was completed | The assessment was conducted using the Pittsburgh Sleep Quality Index (PSQI), with the total score ranging from 0 to 21. A higher score indicates poorer sleep quality. |
| EEG | baseline; 1 day after treatment was completed | EEG features such as event-related potentials (ERPs) and power spectral density (e.g., theta or alpha power) |
| Changes in Reward Learning | baseline; 1 day after treatment was completed | Reward Learning Task |
| use of alcohol | 4 weeks after treatment; 12 weeks after treatment | Simple questionnaire to collect alcohol consumption and drinking frequency. |
Countries
China
Contacts
CONTACTHaifeng Jiang
CONTACTTianzhen Chen
STUDY_CHAIRMin Zhao
Shanghai Mental Health Center
Outcome results
None listed