Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder

Nassima Ait-Daoud Tiouririne

Status: Unknown

Conditions: Alcoholism

Treatments: Device: Transcranial Magnetic Stimulation (rTMS); Device: Sham (SS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03969251

21193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Transcranial Magnetic Stimulation (rTMS)

Experimental group

Description:

repetitive transcranial magnetic stimulation

Treatment:

Device: Transcranial Magnetic Stimulation (rTMS)

Sham (SS)

Sham Comparator group

Description:

repetitive sham rTMS

Treatment:

Device: Sham (SS)