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Completed

NCT Number: NCT03969251

Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UVA Center for Leading Edge Addiction Research

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation (rTMS)

Device

active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex

Sham (SS)

Device

repetitive sham rTMS

Primary outcomes

  1. Wisconsin Card Sorting Test (WCST)

    Time frame: Up to 5 months

    This is a neuropsychological task that measures flexibility in thinking, or "set shifting," during changing reinforcement schedules.

  2. Dimensional Change Card Sort Task (DCCST)

    Time frame: Up to 5 months

    This is a neuropsychological task that measures cognitive flexibility and attention.

  3. Flanker Inhibitory Control and Attention Test (FICAT)

    Time frame: Up to 5 months

    This is a neuropsychological task that measures attention and inhibitory control.

  4. List Sorting Working Memory Test (LSWMT)

    Time frame: Up to 5 months

    This is a neuropsychological task that measures working memory.

Secondary outcomes

  1. Drinks Per Drinking Day

    Time frame: Up to 5 months

    The investigator will use timeline follow-back to capture this drinking outcome.

  2. Percentage of Days of Abstinence

    Time frame: Up to 5 months

    The investigator will use timeline follow-back to capture this drinking outcome.

  3. Percentage of Heavy Drinking Days

    Time frame: Up to 5 months

    The investigator will use timeline follow-back to capture this drinking outcome.

  4. Alcohol Craving Questionnaire (ACQ-NOW)

    Time frame: Up to 5 months

    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.

Sponsors and collaborators

Lead sponsor

Nassima Ait-Daoud Tiouririne

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 31, 2019
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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