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
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Device: Transcranial Magnetic Stimulation (rTMS) Device: Sham (SS)||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- Dimensional Change Card Sort Task (DCCST) [ Time Frame: Up to 5 months ]This is a neuropsychological task that measures cognitive flexibility and attention.
- Flanker Inhibitory Control and Attention Test (FICAT) [ Time Frame: Up to 5 months ]This is a neuropsychological task that measures attention and inhibitory control.
- List Sorting Working Memory Test (LSWMT) [ Time Frame: Up to 5 months ]This is a neuropsychological task that measures working memory.
- Drinks Per Drinking Day [ Time Frame: Up to 5 months ]The investigator will use timeline follow-back to capture this drinking outcome.
- Percentage of Days of Abstinence [ Time Frame: Up to 5 months ]The investigator will use timeline follow-back to capture this drinking outcome.
- Percentage of Heavy Drinking Days [ Time Frame: Up to 5 months ]The investigator will use timeline follow-back to capture this drinking outcome.
- 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.
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
|Contact: Eva Jenkins-Mendoza||(434)email@example.com|
|Contact: Tracie Kostelac||(434)firstname.lastname@example.org|
|Principal Investigator:||Nassima Ait-Daoud TIouririne, M.D.||University of Virginia|