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

NCT03910686 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-03-22

No results posted yet for this study

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.

Conditions

  • Alcohol Dependence

Interventions

COMBINATION_PRODUCT

Transcranial magnetic stimulation and cognitive behavioral therapy

Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03910686 on ClinicalTrials.gov