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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit, 1-4 month follow-ups
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 21 and 75 years old.
Select...
I am between 21 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline visit, 1-4 month follow-ups
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit, 1-4 month follow-ups
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent days abstinent
Percentage of heavy drinking days
Secondary outcome measures
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
~70
Real TBS to the dlPFC
2020
N/A
~70
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,087 Total Patients Enrolled
2 Trials studying Alcoholism
344 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,365,217 Total Patients Enrolled
423 Trials studying Alcoholism
985,528 Patients Enrolled for Alcoholism
Colleen Hanlon, PhDPrincipal InvestigatorWake Forest University
4 Previous Clinical Trials
153 Total Patients Enrolled
1 Trials studying Alcoholism
11 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a serious brain injury that required hospitalization or caused me to lose consciousness for over 10 minutes.I am between 21 and 75 years old.You have used any drugs that affect your mind or mood, except for marijuana and nicotine, in the past month according to what you have told us.I have been diagnosed with schizoaffective disorder.I am not currently experiencing severe withdrawal symptoms.I am at a high risk of having seizures due to my medical history or current medications.You have a score of 8 or higher on the AUDIT (Alcohol Use Disorders Identification Test), which means you are considered a medium or high-risk drinker.I suffer from chronic migraines most days of the month.You drink alcohol at a level that is considered to be medium or high risk according to the AUDIT score.I am between 21 and 75 years old.You are currently having thoughts about hurting yourself or someone else.I do not expect any major changes in my health or life that would affect my study participation.I am not pregnant, nursing, or planning to become pregnant and I use reliable birth control.I am taking medication that affects my alcohol craving or intake.
Research Study Groups:
This trial has the following groups:- Group 1: Sham TBS to the mPFC
- Group 2: Real TBS to the dlPFC
- Group 3: Sham TBS to the dlPFC
- Group 4: Real TBS to the mPFC
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who fulfills the eligibility criteria to join this research endeavor?
"This clinical trial has a narrow eligibility window, as only those between the ages of 21 and 75 who suffer from cravings are being accepted. Approximately 180 suitable participants must be found."
Answered by AI
Does this research program allow individuals older than 35 to participate?
"Patients between the ages of 21 and 75 are eligible for this clinical trial. Those younger than 18 have 20 separate trials, whereas elderly individuals over 65 can find 207 different studies to join."
Answered by AI
How many participants are accepted for inclusion in this research endeavor?
"Indeed, the details on clinicaltrials.gov demonstrate that this medical trial is actively recruiting participants. The study was initiated on May 26th 2020 and was most recently revised on November 10th 2022. A total of 180 individuals are desired to be enrolled across 1 location."
Answered by AI
Is this experiment actively looking for participants?
"Per the details provided on clinicaltrials.gov, this medical trial is actively searching for participants. This clinical trial was first published May 26th 2020 and most recently revised November 10th 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
65+
18 - 65
What site did they apply to?
Wake Forest School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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