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Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder

Primary Purpose

Alcoholism

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (rTMS)
Sham (SS)
Sponsored by
Nassima Ait-Daoud Tiouririne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring alcohol, alcohol dependence, addiction, alcohol use disorder

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UVA Center for Leading Edge Addiction ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Magnetic Stimulation (rTMS)

Sham (SS)

Arm Description

repetitive transcranial magnetic stimulation

repetitive sham rTMS

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Drinks Per Drinking Day
The investigator will use timeline follow-back to capture this drinking outcome.
Percentage of Days of Abstinence
The investigator will use timeline follow-back to capture this drinking outcome.
Percentage of Heavy Drinking Days
The investigator will use timeline follow-back to capture this drinking outcome.
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.

Full Information

First Posted
March 27, 2019
Last Updated
October 25, 2020
Sponsor
Nassima Ait-Daoud Tiouririne
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1. Study Identification

Unique Protocol Identification Number
NCT03969251
Brief Title
Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder
Official Title
Optimizing Treatment for Alcohol Use Disorder (AUD) Using Targeted Transcranial Magnetic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nassima Ait-Daoud Tiouririne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
alcohol, alcohol dependence, addiction, alcohol use disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation (rTMS)
Arm Type
Experimental
Arm Description
repetitive transcranial magnetic stimulation
Arm Title
Sham (SS)
Arm Type
Sham Comparator
Arm Description
repetitive sham rTMS
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (rTMS)
Intervention Description
active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex
Intervention Type
Device
Intervention Name(s)
Sham (SS)
Intervention Description
repetitive sham rTMS
Primary Outcome Measure Information:
Title
Wisconsin Card Sorting Test (WCST)
Description
This is a neuropsychological task that measures flexibility in thinking, or "set shifting," during changing reinforcement schedules.
Time Frame
Up to 5 months
Title
Dimensional Change Card Sort Task (DCCST)
Description
This is a neuropsychological task that measures cognitive flexibility and attention.
Time Frame
Up to 5 months
Title
Flanker Inhibitory Control and Attention Test (FICAT)
Description
This is a neuropsychological task that measures attention and inhibitory control.
Time Frame
Up to 5 months
Title
List Sorting Working Memory Test (LSWMT)
Description
This is a neuropsychological task that measures working memory.
Time Frame
Up to 5 months
Secondary Outcome Measure Information:
Title
Drinks Per Drinking Day
Description
The investigator will use timeline follow-back to capture this drinking outcome.
Time Frame
Up to 5 months
Title
Percentage of Days of Abstinence
Description
The investigator will use timeline follow-back to capture this drinking outcome.
Time Frame
Up to 5 months
Title
Percentage of Heavy Drinking Days
Description
The investigator will use timeline follow-back to capture this drinking outcome.
Time Frame
Up to 5 months
Title
Alcohol Craving Questionnaire (ACQ-NOW)
Description
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.
Time Frame
Up to 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Jenkins-Mendoza
Phone
(434)243-0562
Email
emj9c@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tracie Kostelac
Phone
(434)243-0563
Email
tlk5d@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nassima Ait-Daoud TIouririne, M.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVA Center for Leading Edge Addiction Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Jenkins-Mendoza
Phone
434-243-0562
Email
emj9c@virginia.edu
First Name & Middle Initial & Last Name & Degree
Tracie Kostelac
Phone
(434)243-0563
Email
tlk5d@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder

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