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Behavioural Intervention

Transcranial Magnetic Stimulation for Alcoholism

N/A
Recruiting
Led By Colleen Hanlon, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-75
Age 21- 75.
Must not have
History of traumatic brain injury resulting in hospitalization, loss of consciousness for more than 10 minutes, and/or having ever been informed he/she has an epidural, subdural, or subarachnoid hemorrhage
Meets DSM V criteria for schizoaffective disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit, 1-4 month follow-ups

Summary

This trial will test if transcranial magnetic stimulation can help people with alcohol use disorder abstain from drinking.

Who is the study for?
This trial is for adults aged 21-75 with Alcohol Use Disorder (AUD), as indicated by an AUDIT score above 8. Participants must meet DSM-V criteria for AUD and cannot be at risk of pregnancy, nursing, or planning a pregnancy without reliable birth control. They should not have suicidal/homicidal thoughts, expect major medical changes soon, use psychoactive substances (except marijuana/nicotine) recently, or be on medications affecting alcohol intake/craving.
What is being tested?
The study tests two transcranial magnetic stimulation (TMS) strategies to reduce alcohol consumption in individuals seeking treatment for AUD. It compares the effects of Real TBS versus Sham TBS applied to either the ventromedial prefrontal cortex (vmPFC) or dorsolateral prefrontal cortex (dlPFC) over four months on abstinence and reaction to alcohol cues.
What are the potential side effects?
While TMS is generally considered safe, potential side effects include discomfort at the stimulation site, headache, lightheadedness, and in rare cases seizures. Chronic migraine sufferers are excluded from this trial due to these possible side effects.

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 75 years old.
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I am between 21 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a serious brain injury that required hospitalization or caused me to lose consciousness for over 10 minutes.
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I have been diagnosed with schizoaffective disorder.
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I am not currently experiencing severe withdrawal symptoms.
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I am at a high risk of having seizures due to my medical history or current medications.
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I suffer from chronic migraines most days of the month.
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I am not pregnant, nursing, or planning to become pregnant and I use reliable birth control.
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I am taking medication that affects my alcohol craving or intake.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit, 1-4 month follow-ups
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit, 1-4 month follow-ups for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent days abstinent
Percentage of heavy drinking days
Secondary study objectives
Changes in Craving
Neuroimaging outcomes: change in drug cue reactivity as specified by changes in BOLD signal

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Real TBS to the mPFCExperimental Treatment1 Intervention
Thirty sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC)
Group II: Real TBS to the dlPFCExperimental Treatment1 Intervention
Thirty sessions of real Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC)
Group III: Sham TBS to the mPFCPlacebo Group1 Intervention
Thirty sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC)
Group IV: Sham TBS to the dlPFCPlacebo Group1 Intervention
Thirty sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Real TBS to the vmPFC
2020
N/A
~40

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,401 Previous Clinical Trials
2,460,125 Total Patients Enrolled
2 Trials studying Alcoholism
344 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
839 Previous Clinical Trials
1,083,468 Total Patients Enrolled
459 Trials studying Alcoholism
823,651 Patients Enrolled for Alcoholism
Colleen Hanlon, PhDPrincipal InvestigatorWake Forest University
4 Previous Clinical Trials
128 Total Patients Enrolled
1 Trials studying Alcoholism
11 Patients Enrolled for Alcoholism
Merideth A Addicott, PhDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
143 Total Patients Enrolled

Media Library

Theta Burst Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04154111 — N/A
Alcoholism Research Study Groups: Sham TBS to the mPFC, Real TBS to the dlPFC, Sham TBS to the dlPFC, Real TBS to the mPFC
Alcoholism Clinical Trial 2023: Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT04154111 — N/A
Theta Burst Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04154111 — N/A
~20 spots leftby Aug 2025
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