Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder

Last updated: October 25, 2020
Sponsor: Nassima Ait-Daoud Tiouririne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alcohol Dependence

Addictions

Alcohol Use Disorder

Treatment

N/A

Clinical Study ID

NCT03969251
21193
  • Ages > 22
  • All Genders

Study Summary

This is a pilot study designed to evaluate the efficacy of High Frequency (HF) repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (L-DLPFC) at improving cognitive flexibility in recently detoxified individuals with alcohol use disorder (AUD) compared to placebo (Sham rTMS). The total number of subjects requested to be randomized is 20. The investigator will need to screen about 40 subjects to have 20 subjects started on rTMS session at a ratio of 2 screens/1 subject randomized.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Right handed males and females who have given written informed consent.
  • Age 22 years and above with a history of alcohol use disorder
  • Good physical health
  • Have a current diagnosis of alcohol use disorder
  • Reports at least 4 "heavy drinking days" on average in the past 30 days.
  • Have a BAC by breathalyzer equal to 0.000 when the participants signed the informedconsent document
  • Six months stability on any psychotropic medications
  • Not have any unresolved legal problems that could jeopardize continuation orcompletion of the study.
  • Be able to provide written informed consent, able to understand written and oralinstructions in English and be able to complete the questionnaires required by theprotocol.

Exclusion

Exclusion Criteria: Please contact site for additional information.

Study Design

Total Participants: 20
Study Start date:
July 01, 2019
Estimated Completion Date:
June 30, 2021

Study Description

This is a randomized double- blind, control study.

To test the hypothesis, the investigator propose a 2 phase design:

Phase 1: 6-week trial comparing the efficacy of active high-frequency (HF) rTMS of L-DLPFC versus sham (SS) rTMS to determine if HF rTMS improves cognitive flexibility in recently detoxified alcoholics Phase 2: at the end of TMS phase, all participants will receive cognitive behavioral therapy (CBT) thus permitting participants with AUD to benefit from cognitive restructuring in CBT, and reduce alcohol cravings and drinking outcomes.

This study will recruit 20 individuals with AUD, comprising of both male and female participants, age 22 years and older interested in alcohol drinking abstinence. Participants will be recruited from the inpatient unit upon discharge after receiving a detoxification treatment and therefore will be abstinent at study entry. Prior to treatment onset and weekly throughout the course of treatment, participants will complete cognitive testing/measures, Wisconsin Card Sorting Task (WCST), Dimensional Change Card Sort Task (DCCST), Barratt Impulsiveness Scale (BIS), Flanker Inhibitory Control and Attention Test (FICAT), and List Sorting Working Memory Test (LSWMT) and self-reported craving measures, Alcohol Craving Questionnaire (ACQ-Now), and Obsessive Compulsive Drinking Scale (OCDS). The drinking timeline follow-back, and adverse events will also be assessed weekly for 8 weeks.

Participant will be randomized to either high frequency (HF) or sham repetitive transcranial magnetic stimulation (SS rTMS), which will be done 5 days per week for 6 weeks. At the end of 6 weeks, all participants will receive weekly CBT for a total of 8 weeks. Participants will return at 2 and 4 weeks for follow-up assessments.

Connect with a study center

  • UVA Center for Leading Edge Addiction Research

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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