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Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT03969251
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nassima Ait-Daoud Tiouririne, University of Virginia

Brief 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.

Condition or disease Intervention/treatment Phase
Alcoholism Device: Transcranial Magnetic Stimulation (rTMS) Device: Sham (SS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Treatment for Alcohol Use Disorder (AUD) Using Targeted Transcranial Magnetic Stimulation
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969251


Contacts
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Contact: Eva Jenkins-Mendoza (434)243-0562 emj9c@virginia.edu
Contact: Tracie Kostelac (434)243-0563 tlk5d@virginia.edu

Locations
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United States, Virginia
UVA Center for Leading Edge Addiction Research Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Eva Jenkins-Mendoza    434-243-0562    emj9c@virginia.edu   
Contact: Tracie Kostelac    (434)243-0563    tlk5d@virginia.edu   
Sponsors and Collaborators
Nassima Ait-Daoud Tiouririne
Investigators
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Principal Investigator: Nassima Ait-Daoud TIouririne, M.D. University of Virginia
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Responsible Party: Nassima Ait-Daoud Tiouririne, Associate Professor, Director of UVA Center for Leading Edge Addiction Research, University of Virginia
ClinicalTrials.gov Identifier: NCT03969251    
Other Study ID Numbers: 21193
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Nassima Ait-Daoud Tiouririne, University of Virginia:
alcohol
alcohol dependence
addiction
alcohol use disorder
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders