Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder

Optimizing Treatment for Alcohol Use Disorder (AUD) Using Targeted Transcranial Magnetic Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Alcoholism
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation (rTMS); Device: Sham (SS)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • UVA Center for Leading Edge Addiction Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 informed consent document
• Six months stability on any psychotropic medications
• Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
• Be able to provide written informed consent, able to understand written and oral instructions in English and be able to complete the questionnaires required by the protocol.

Exclusion Criteria:

Please contact site for additional information.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial Magnetic Stimulation (rTMS); repetitive transcranial magnetic stimulation	Device: Transcranial Magnetic Stimulation (rTMS); active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex
Sham Comparator: Sham (SS); repetitive sham rTMS	Device: Sham (SS); repetitive sham rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wisconsin Card Sorting Test (WCST)	This is a neuropsychological task that measures flexibility in thinking, or "set shifting," during changing reinforcement schedules.	Up to 5 months
Dimensional Change Card Sort Task (DCCST)	This is a neuropsychological task that measures cognitive flexibility and attention.	Up to 5 months
Flanker Inhibitory Control and Attention Test (FICAT)	This is a neuropsychological task that measures attention and inhibitory control.	Up to 5 months
List Sorting Working Memory Test (LSWMT)	This is a neuropsychological task that measures working memory.	Up to 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinks Per Drinking Day	The investigator will use timeline follow-back to capture this drinking outcome.	Up to 5 months
Percentage of Days of Abstinence	The investigator will use timeline follow-back to capture this drinking outcome.	Up to 5 months
Percentage of Heavy Drinking Days	The investigator will use timeline follow-back to capture this drinking outcome.	Up to 5 months
Alcohol Craving Questionnaire (ACQ-NOW)	This is a 47-item self-administered, multidimensional state measure of acute alcohol craving adapted from the Cocaine Craving Questionnaire. It measures the subscales of alcohol craving labeled Emotionality, Purposefulness, Compulsivity, and Expectancy.	Up to 5 months

Collaborators and Investigators

• Sponsor: Nassima Ait-Daoud Tiouririne
• Investigators: Principal Investigator: Nassima Ait-Daoud Tiouririne, M.D., University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: alcohol dependence; addiction; alcohol; alcohol use disorder
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Alcoholism; Behavior, Addictive; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: 21193

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: Yes