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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder

Clinicaltrials.gov identifier NCT03932149

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted March 25, 2020

Study Description

Brief summary:

The aim of this trial is to investigate the efficacy of left DLPFC iTBS in a population of alcohol use disorder patients, compared with the sham iTBS. Moreover, this trial will conduct follow-up assessments to evaluate whether its efficacy can sustain for a long time if it is effective.

  • Condition or Disease:Alcohol Use Disorder
  • Intervention/Treatment: Device: Intermittent Theta Burst Stimulation (iTBS)
    Device: Sham stimulation
  • Phase: N/A
Detailed Description

Alcohol abuse and alcohol use disorder are important major health issues in our modern society. However, the treatment of alcohol addiction is currently limited to the treatment of acute withdrawal symptoms, but lacks effective interventions to reduce craving and prevent relapse. In an attempt to improve the treatment of substance dependence, non-invasive neuromodulation has gained attention as a new potential treatment option. The aim of this trial is to investigate the efficacy of left DLPFC iTBS in a population of alcohol use disorder patients, compared with the sham iTBS. Moreover, this trial will conduct follow-up assessments to evaluate whether its efficacy can sustain for a long time if it is effective.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder
  • Actual Study Start Date: December 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: March 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Experimental Group
Real stimulation
Device: Intermittent Theta Burst Stimulation (iTBS)
The target is left DLPFC and the iTBS protocol is: 70% of RMT; triplet 50 Hz bursts, repeated at 5 Hz; 2s on and 8s off; 600 pulses a session.
Sham Comparator: Control Group
Sham stimulation
Device: Sham stimulation
The target is right DLPFC and the sham stimulation protocol is: triplet 50 Hz bursts, repeated at 5 Hz; 2s on and 8s off; 600 pulses a session.
Outcome Measures
  • Primary Outcome Measures: 1. Craving change [ Time Frame: baseline, after the intervention, and 3 months after the intervention ]
    Craving will be measured by visual analogue scale(VAS), participants specify their level of craving by indicating a position along a continuous line between two end-points, score ranges from 0 to 10, 0 refers to the lowest level of craving, 10 refers to the highest level of craving.
  • Secondary Outcome Measures: 1. The abstinence rate after the treatment [ Time Frame: after the intervention, and 3 months after the intervention ]
    The abstinence rate defined as the number of abstinent days in the three months after the last simulation session
  • 2. Change of depression [ Time Frame: bbaseline, after the 2-weeks intervention, and 6 months after the intervention ]
    The decrease of Beck Depression Inventory (BDI) scores, a 21-question multiple-choice self-report inventory to measure the severity of depression .
  • 3. Change of anxiety [ Time Frame: baseline, after the 2-weeks intervention, and 6 months after the intervention ]
    The decrease of Beck Anxiety Inventory (BAI) scores, a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety.
  • 4. Change of impulsiveness [ Time Frame: baseline, after the 2-weeks intervention, and 6 months after the intervention ]
    The decrease of Barratt impulsiveness scale (BIS) scores,including 30 items.
  • 5. Change of impulse control [ Time Frame: baseline, after the 2-weeks intervention, and 6 months after the intervention ]
    The decrease of stop signal reaction time (SSRT) in the stop signal task.
  • 6. Change of cognitive function [ Time Frame: baseline, after the 2-weeks intervention, and 6 months after the intervention ]
    The increase of Cogstate scores.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- a DSM-5 diagnosis of alcohol use disorder

- age between 18 and 65

- can return to the research center for successive visits.

Exclusion Criteria:

- severe cognitive impairment

- current DSM-5 diagnosis of schizophrenia or another psychotic disorder

- current other substance abuse (except nicotine)

- severe organic diseases

- rTMS contraindications (such as a history of epileptic seizures, metal implants near
the head).

Contacts and Locations
Contacts

Contact: Chenxin Yuan 18616819260 yuan_ycx@163.com

Locations

China, Shanghai
Shanghai Mental Health Center
Shanghai

Sponsors and Collaborators

Shanghai Mental Health Center

More Information
  • Responsible Party: Shanghai Mental Health Center
  • ClinicalTrials.gov Identifier: NCT03932149 History of Changes
  • Other Study ID Numbers: JDu-007
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: March 25, 2020
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Shanghai Mental Health Center: Alcohol Use Disorder
    Intermittent Theta Burst Stimulation
    Alcohol Dependence
  • Additional relevant MeSH terms: Alcoholism
    Disease
    Alcohol Drinking