Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03969251
• Other study ID #: 21193
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 2021

Study information

• Verified date: October 2020
• Source: University of Virginia
• Contact: Eva Jenkins-Mendoza
• Phone: (434)243-0562
• Email: emj9c[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcoholism

Intervention

Device:
• Transcranial Magnetic Stimulation (rTMS)
active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex
• Sham (SS)
repetitive sham rTMS

Locations

Country	Name	City	State
United States	UVA Center for Leading Edge Addiction Research	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Nassima Ait-Daoud Tiouririne

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Dimensional Change Card Sort Task (DCCST)	This is a neuropsychological task that measures cognitive flexibility and attention.	Up to 5 months
Primary	Flanker Inhibitory Control and Attention Test (FICAT)	This is a neuropsychological task that measures attention and inhibitory control.	Up to 5 months
Primary	List Sorting Working Memory Test (LSWMT)	This is a neuropsychological task that measures working memory.	Up to 5 months
Secondary	Drinks Per Drinking Day	The investigator will use timeline follow-back to capture this drinking outcome.	Up to 5 months
Secondary	Percentage of Days of Abstinence	The investigator will use timeline follow-back to capture this drinking outcome.	Up to 5 months
Secondary	Percentage of Heavy Drinking Days	The investigator will use timeline follow-back to capture this drinking outcome.	Up to 5 months
Secondary	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