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Behavioural Intervention
Transcranial Magnetic Stimulation for Alcoholism
N/A
Recruiting
Led By Timothy C. Durazzo, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants will be abstinent from alcohol and non-prescribed substances for at least 7 consecutive days prior to active or sham rTMS and no participant demonstrates active acute withdrawal symptoms.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will help determine if rTMS is an effective treatment for AUD in Veterans, which could lead to long-term sobriety for those suffering from the disorder.
Who is the study for?
This trial is for Veterans with Alcohol Use Disorder (AUD) who are currently in treatment, have identified alcohol as their primary substance of misuse, and have been sober for at least 7 days. They must be stable on any psychotropic medication and able to consent to the study. Exclusions include pregnancy, severe medical conditions like Parkinson's or recent cancer treatment, low English fluency, certain psychiatric disorders, use of medications that lower seizure threshold, and previous brain stimulation treatments.Check my eligibility
What is being tested?
The trial tests repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation method for treating AUD in Veterans. Participants will receive either active rTMS or a sham (placebo) version to assess the effectiveness of rTMS in promoting long-term abstinence from alcohol.See study design
What are the potential side effects?
While rTMS is generally considered safe, potential side effects may include discomfort at the site of stimulation on the scalp, headache, lightheadedness or dizziness. There's also a rare risk of seizure associated with this type of brain stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't used alcohol or non-prescribed drugs for at least 7 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of abstinence from alcohol and other substances
Secondary outcome measures
BDNF polymorphisms (as measured with TaqMan genotyping assays or similar assays)
Functional connectivity (as measured with resting state fMRI)
Glutamate concentration in the left dorsolateral prefrontal cortex (as measured with single voxel spectroscopy)
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: active rTMSActive Control1 Intervention
Active rTMS will receive an intermittent rTMS stimulation protocol.
Group II: sham rTMSPlacebo Group1 Intervention
Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,084 Total Patients Enrolled
41 Trials studying Alcoholism
6,239 Patients Enrolled for Alcoholism
Timothy C. Durazzo, PhDPrincipal InvestigatorVA Palo Alto Health Care System, Palo Alto, CA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot stop my current medications for a study.I have had a brain injury with a loss of consciousness for more than 30 minutes.I am taking acamprosate.You have been diagnosed with schizophrenia or related mental health disorders in the past.Could you please provide more specific information about the psychiatric exclusion criteria?You have a significant problem with using substances, such as drugs or alcohol, that is more severe than an alcohol use disorder.You are currently feeling very sad and have thoughts of hurting yourself or have a plan to do so.My diabetes is not well-controlled.I have been diagnosed with Alzheimer's disease.I have Parkinson's disease.I have seizures due to a brain condition or injury.I'm sorry, but the criterion "General" is too vague. Could you please provide more specific details or context?I am not fluent in English.I am not pregnant nor trying to get pregnant.I am currently receiving treatment for alcohol use disorder.I am taking medication for depression, smoking, or other mental health issues.My medications do not increase my risk of seizures.I have been diagnosed with bipolar disorder.I am currently taking FDA-approved medication for alcohol use disorder.I am not taking disulfiram.I have never had rTMS or electroconvulsive treatment.I am participating in a medical study.My thyroid condition is under control.I have unstable heart failure.I experience chest pain due to heart issues.My heart condition hasn't required changes in my treatment in the last 3 months.I have had a stroke.My cancer treatment ended less than a year ago.I am not taking any medication that lowers seizure risk or is unsafe with rTMS.I haven't used alcohol or non-prescribed drugs for at least 7 days.I need extra oxygen because of my COPD.You have any medical implants with metal that can be affected by magnets.I have been on the same mental health medication for at least 1 month.I am not currently taking naltrexone.You have a device implanted in your body that stimulates your nerves.You have a heart device like a pacemaker or cannot undergo magnetic resonance imaging (MRI) scans.You have a significant problem with your ability to think and understand things.
Research Study Groups:
This trial has the following groups:- Group 1: active rTMS
- Group 2: sham rTMS
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.
Are there any qualifications that would enable my participation in this trial?
"This clinical trial is recruiting a cohort of 100 individuals between their 21st and 65th birthdays who suffer from alcohol abuse disorder. In order to ensure the safety of participants, they must have discontinued any medications that could increase seizure risk for seven days leading up to rTMS treatment; be abstinent from recreational substances or alcohol in the week prior to testing; been prescribed medication for depressive disorders, smoking cessation, or other psychiatric issues for at least one month before enrollment; and not display acute withdrawal symptoms."
Answered by AI
Is enrollment still open for this trial?
"Data hosted on clinicaltrials.gov reveals a current recruitment effort for this medical trial, which was first published on April 15th 2018 and modified November 14th 2022."
Answered by AI
What is the total sample size of this research endeavor?
"Yes, this clinical trial is open for enrolment. The initial post date was April 15th 2018 and the most recent update was November 14th 2022; 100 participants are needed from 1 medical site."
Answered by AI
Is this medical research open to geriatric participants?
"To comply with the stated eligibility requirements, interested participants should be between 21 years old and 65 years of age."
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