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Behavioural Intervention

TMS for Alcoholism

N/A

Recruiting

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21-65

Consumption of more than 14 drinks (women) or 21 drinks (men) per week, with at least 4 heavy drinking days per week during the 30-days prior to enrolling

Must not have

Females of childbearing potential who are pregnant, nursing, or not using a reliable form of birth control

Has a history of chronic migraines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 1), post-treatment (4-weeks from baseline), 1-month post treatment (follow-up #1), 2-months post treatment (follow-up #2), 3-months post treatment (follow-up #3)

Summary

This trial will test whether transcranial magnetic stimulation (TMS) can be used to reduce the desire to drink alcohol and the brain's response to alcohol-related pictures.

Who is the study for?

This trial is for adults aged 21-65 who drink heavily, meeting specific criteria (over 14 drinks per week for women and over 21 for men). Participants must have Alcohol Use Disorder as defined by DSM-V. Exclusions include unstable medical conditions, metal implants above the neck, pregnancy or inadequate birth control use, certain psychiatric disorders, history of severe head injury or substance abuse other than nicotine.

What is being tested?

The study tests theta burst stimulation (TBS) to the medial prefrontal cortex (mPFC) using transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique. It aims to see if TBS can reduce alcohol cravings and alter responses to alcohol-related cues. Participants will receive either real TBS or a sham procedure as a control.

What are the potential side effects?

Potential side effects from TMS/TBS may include discomfort at the site of stimulation, headache, lightheadedness, risk of seizure in susceptible individuals although rare with modern protocols, and temporary hearing changes due to the noise during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 65 years old.

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I drink more than the recommended weekly limit and have heavy drinking days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, nursing, or I am using reliable birth control.

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I have a long-term history of chronic migraines.

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I have had a serious brain injury that required hospital care.

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I have a health condition that needs immediate treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 1), post-treatment (4-weeks from baseline), 1-month post treatment (follow-up #1), 2-months post treatment (follow-up #2), 3-months post treatment (follow-up #3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 1), post-treatment (4-weeks from baseline), 1-month post treatment (follow-up #1), 2-months post treatment (follow-up #2), 3-months post treatment (follow-up #3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1), post-treatment (4-weeks from baseline), 1-month post treatment (follow-up #1), 2-months post treatment (follow-up #2), 3-months post treatment (follow-up #3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Percent Days Abstinent (PDA) from baseline

Change in Percent Heavy Drinking Days (PHDD) from baseline

Change in alcohol cue task MRI activation 1-week post treatment from baseline

Secondary study objectives

Change in alcohol use via Alcohol Audit from baseline

Alcohol Use Disorder

Change in anxiety via State-Trait Anxiety Inventory from baseline

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Real TBS to the mPFCExperimental Treatment1 Intervention

For continuous theta burst stimulation (cTBS), participants will receive 3 sessions of stimulation per visit over the left medial prefrontal cortex (mPFC) (each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec, 600 pulses/session, 60 sec intertrain interval; 120% RMT, MagPro; 10-15 min inter session interval) using a figure 8 coil (Coil Cool-B65 A/P).

Group II: Sham TBS to the mPFCPlacebo Group1 Intervention

The MagVenture MagPro system has an integrated, active sham which passes current through two surface electrodes placed on the scalp. The electrodes will be placed on the left frontalis muscle for all sessions. A patient identification card will randomize participants to receive either real or sham stimulation. This system maintains blinding by a gyroscope in the coil which indicates to the clinical staff whether the coil should be rotated up or down for this participant once the card is entered into the machine. One side of the coil is active, the other is sham. The integrity of the double-blind procedure will be assessed by asking the patients and study personnel rate their confidence regarding whether they thought they received real or sham (scale 1-10).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Real TBS to the mPFC

2020

N/A

~40

0 / 6Eligibility criteria met