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Alcohol dependence is one of most common substance dependence, which brings great burden on health worldwide. Alcohol dependence may lead to many serious diseases or consequences including cancer, cardiovascular diseases and accidents. Once alcohol dependence is developed, it will be difficult to recover and easy to relapse. Although many efforts had been made in the treatment of alcohol dependence, the annual recurrence of alcohol dependence with traditional therapies was over 45%. Repetitive transcranial magnetic stimulation (rTMS) on the dorsolateral prefrontal cortex (DLPFC) or cognitive behavioral therapy (CBT) each alone was reported to have some effect on preventing from relapse of alcohol dependence. In order to test whether combined therapy of high frequency rTMS (hf-rTMS) with CBT is better for preventing from relapse of alcohol dependence, we recruit patients with alcohol dependence to participate this study. The study is a factorial designed and the patients will be assigned into one of the following six groups randomly: (1) regular treatment (symptomatic treatment) with blank TMS; (2) regular treatment (RT) with blank TMS and CBT; (3) RT with right DLPFC hf-rTMS; (4) RT with right DLPFC hf-rTMS and CBT; (5) RT with left DLPFC hf-rTMS; (6) RT with left DLPFC hf-rTMS and CBT. TMS was given 5 days per week for total 2 weeks using uniform scheme (5 seconds of 10Hz stimulation per train, 30 trains per day with inter-train interval of 20 seconds). CBT will be given once per week for total 8 weeks. The patients will be followed up for 6 months. Recurrence of alcohol dependence, duration of abstention, alcohol intake, craving for alcohol and other cognitive psychological assessments will be recorded and compared among the 6 treatment groups and the efficacy of combined therapy of rTMS with CBT will be evaluated in our study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular treatment (symptomatic treatment) with blank TMS | Placebo Comparator | Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation |
|
| Regular treatment (RT) with blank TMS and CBT | Active Comparator | Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy |
|
| RT with right DLPFC hf-rTMS | Active Comparator | Regular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS) |
|
| RT with right DLPFC hf-rTMS and CBT | Active Comparator | Regular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT) |
|
| RT with left DLPFC hf-rTMS | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial magnetic stimulation and cognitive behavioral therapy | Combination Product | Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of relapse of alcohol dependence after discharge from hospital | Recurrence of alcohol dependence | 1 month |
| The rate of relapse of alcohol dependence after discharge from hospital | 2 month | |
| The rate of relapse of alcohol dependence after discharge from hospital | 3 month | |
| The rate of relapse of alcohol dependence after discharge from hospital | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of abstinence | The total time or period without any intake of alcohol during follow ups | 6 months |
| Alcohol intake | Diaries of alcohol intake in different time of the follow ups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Peng, MD, PhD | Contact | +86-13380051581 | pengy2@mail.sysu.edu.cn | |
| Hongxuan Wang, MD, PhD | Contact | +86-13824498978 | wanghx8@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19524780 | Background | Phillips MR, Zhang J, Shi Q, Song Z, Ding Z, Pang S, Li X, Zhang Y, Wang Z. Prevalence, treatment, and associated disability of mental disorders in four provinces in China during 2001-05: an epidemiological survey. Lancet. 2009 Jun 13;373(9680):2041-53. doi: 10.1016/S0140-6736(09)60660-7. | |
| 22683652 | Background |
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Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
|
| RT with left DLPFC hf-rTMS and CBT | Active Comparator | Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT) |
|
| 2 weeks, 1 month, 2 months, 3 months and 6 months |
| Craving for alcohol | Craving assessment for alcohol by Obsessive Compulsive Drinking Scale (OCDS) ranging from 0 to 40. Higher score of OCDS indicates more desire for alcohol. | 2 weeks, 1 month, 2 months, 3 months and 6 months |
| Craving for alcohol | Craving assessment by Visual Analogue Scale (VAS) for alcohol desire ranging from 0 to 10. Higher score indicates more desire for alcohol. | 2 weeks, 1 month, 2 months, 3 months and 6 months |
| Cognitive assessment | Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function. | 2 weeks, 1 month, 2 months, 3 months and 6 months |
| Psychological assessment - Anxiety | Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety. | 2 weeks, 1 month, 2 months, 3 months and 6 months |
| Psychological assessment - Depression | Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression. | 2 weeks, 1 month, 2 months, 3 months and 6 months |
| Psychological assessment - Sleep | Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep. | 2 weeks, 1 month, 2 months, 3 months and 6 months |
| Tang YL, Hao W, Leggio L. Treatments for alcohol-related disorders in China: a developing story. Alcohol Alcohol. 2012 Sep-Oct;47(5):563-70. doi: 10.1093/alcalc/ags066. Epub 2012 Jun 7. |
| 20078462 | Background | Mishra BR, Nizamie SH, Das B, Praharaj SK. Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. Addiction. 2010 Jan;105(1):49-55. doi: 10.1111/j.1360-0443.2009.02777.x. |
| 23709633 | Background | Herremans SC, Vanderhasselt MA, De Raedt R, Baeken C. Reduced intra-individual reaction time variability during a Go-NoGo task in detoxified alcohol-dependent patients after one right-sided dorsolateral prefrontal HF-rTMS session. Alcohol Alcohol. 2013 Sep-Oct;48(5):552-7. doi: 10.1093/alcalc/agt054. Epub 2013 May 24. |
| 25255169 | Background | Mishra BR, Praharaj SK, Katshu MZ, Sarkar S, Nizamie SH. Comparison of anticraving efficacy of right and left repetitive transcranial magnetic stimulation in alcohol dependence: a randomized double-blind study. J Neuropsychiatry Clin Neurosci. 2015 Winter;27(1):e54-9. doi: 10.1176/appi.neuropsych.13010013. |
| 26727534 | Background | Herremans SC, De Raedt R, Van Schuerbeek P, Marinazzo D, Matthys F, De Mey J, Baeken C. Accelerated HF-rTMS Protocol has a Rate-Dependent Effect on dACC Activation in Alcohol-Dependent Patients: An Open-Label Feasibility Study. Alcohol Clin Exp Res. 2016 Jan;40(1):196-205. doi: 10.1111/acer.12937. |
| 28549424 | Background | Sundstrom C, Kraepelien M, Eek N, Fahlke C, Kaldo V, Berman AH. High-intensity therapist-guided internet-based cognitive behavior therapy for alcohol use disorder: a pilot study. BMC Psychiatry. 2017 May 26;17(1):197. doi: 10.1186/s12888-017-1355-6. |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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