Clinical trial NCT03969251: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Alcoholism
Keywords: alcohol
alcohol dependence
addiction
alcohol use disorder
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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Primary outcomes:
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: Up to 5 months
measure: Dimensional Change Card Sort Task (DCCST)
timeFrame: Up to 5 months
measure: Flanker Inhibitory Control and Attention Test (FICAT)
timeFrame: Up to 5 months
measure: List Sorting Working Memory Test (LSWMT)
timeFrame: Up to 5 months
Secondary outcomes:
measure: Drinks Per Drinking Day
timeFrame: Up to 5 months
measure: Percentage of Days of Abstinence
timeFrame: Up to 5 months
measure: Percentage of Heavy Drinking Days
timeFrame: Up to 5 months
measure: Alcohol Craving Questionnaire (ACQ-NOW)
timeFrame: Up to 5 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: UVA Center for Leading Edge Addiction Research
state: Virginia
Study officials:
affiliation: University of Virginia
name: Nassima Ait-Daoud TIouririne, M.D.
role: PRINCIPAL_INVESTIGATOR
References: