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Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Alcohol Dependence (TAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03910686
Recruitment Status : Not yet recruiting
First Posted : April 10, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ying Peng, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Alcohol Dependence
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Regular treatment (symptomatic treatment) with blank TMS
Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation
Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy

Active Comparator: Regular treatment (RT) with blank TMS and CBT
Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy
Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy

Active Comparator: RT with right DLPFC hf-rTMS
Regular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy

Active Comparator: RT with right DLPFC hf-rTMS and CBT
Regular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy

Active Comparator: RT with left DLPFC hf-rTMS
Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy

Active Comparator: RT with left DLPFC hf-rTMS and CBT
Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy




Primary Outcome Measures :
  1. The rate of relapse of alcohol dependence after discharge from hospital [ Time Frame: 1 month ]
    Recurrence of alcohol dependence

  2. The rate of relapse of alcohol dependence after discharge from hospital [ Time Frame: 2 month ]
  3. The rate of relapse of alcohol dependence after discharge from hospital [ Time Frame: 3 month ]
  4. The rate of relapse of alcohol dependence after discharge from hospital [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Duration of abstinence [ Time Frame: 6 months ]
    The total time or period without any intake of alcohol during follow ups

  2. Alcohol intake [ Time Frame: 2 weeks, 1 month, 2 months, 3 months and 6 months ]
    Diaries of alcohol intake in different time of the follow ups

  3. Craving for alcohol [ Time Frame: 2 weeks, 1 month, 2 months, 3 months and 6 months ]
    Craving assessment for alcohol by Obsessive Compulsive Drinking Scale (OCDS) ranging from 0 to 40. Higher score of OCDS indicates more desire for alcohol.

  4. Craving for alcohol [ Time Frame: 2 weeks, 1 month, 2 months, 3 months and 6 months ]
    Craving assessment by Visual Analogue Scale (VAS) for alcohol desire ranging from 0 to 10. Higher score indicates more desire for alcohol.

  5. Cognitive assessment [ Time Frame: 2 weeks, 1 month, 2 months, 3 months and 6 months ]
    Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.

  6. Psychological assessment - Anxiety [ Time Frame: 2 weeks, 1 month, 2 months, 3 months and 6 months ]
    Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety.

  7. Psychological assessment - Depression [ Time Frame: 2 weeks, 1 month, 2 months, 3 months and 6 months ]
    Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression.

  8. Psychological assessment - Sleep [ Time Frame: 2 weeks, 1 month, 2 months, 3 months and 6 months ]
    Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis as alcohol dependence according to DSM-IV criteria
  • No definite history of neurological diseases and psychological problems
  • Volunteer to participate the study, cooperate to be followed up

Exclusion Criteria:

  • Acute withdrawal state and CIWA score > 9
  • With other neurological diseases and psychological problems
  • With ever brain trauma and damage
  • With other psychological medications or other substance dependence
  • With other contraindications to have transcranial magnetic stimulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910686


Contacts
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Contact: Ying Peng, MD, PhD +86-13380051581 pengy2@mail.sysu.edu.cn
Contact: Hongxuan Wang, MD, PhD +86-13824498978 wanghx8@mail.sysu.edu.cn

Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Publications:

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Responsible Party: Ying Peng, Professor, Director of Department of Neurology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03910686    
Other Study ID Numbers: 2019-12-TMSCBT
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ying Peng, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
Alcohol Dependence, transcranial magnetic stimulation, cognitive behavioral therapy
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders