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

March 19, 2021 updated by: Ying Peng, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of relapse of alcohol dependence after discharge from hospital
Time Frame: 1 month
Recurrence of alcohol dependence
1 month
The rate of relapse of alcohol dependence after discharge from hospital
Time Frame: 2 month
2 month
The rate of relapse of alcohol dependence after discharge from hospital
Time Frame: 3 month
3 month
The rate of relapse of alcohol dependence after discharge from hospital
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of abstinence
Time Frame: 6 months
The total time or period without any intake of alcohol during follow ups
6 months
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.
2 weeks, 1 month, 2 months, 3 months and 6 months
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.
2 weeks, 1 month, 2 months, 3 months and 6 months
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.
2 weeks, 1 month, 2 months, 3 months and 6 months
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.
2 weeks, 1 month, 2 months, 3 months and 6 months
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
2 weeks, 1 month, 2 months, 3 months and 6 months
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.
2 weeks, 1 month, 2 months, 3 months and 6 months
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.
2 weeks, 1 month, 2 months, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2019

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (ACTUAL)

April 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-12-TMSCBT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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