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Tests treatment safety and results for Alcohol Use Disorder
Official title Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
ClinicalTrials.gov ID: NCT07216872
What this study is testing
- What it's testing
- The study will compare alcohol use in two groups of subjects. One group will be assigned to the Deep TMS treatment and the other group will be assigned to the sham treatment.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 86
You may be able to join if
- Male or female people, 18-86 years old.
- people diagnosed with AUD and who meet criteria for moderate (4-5 out of the 12 symptoms) to severe (\> 6 out of the 12 symptoms) AUD according to...
- people who have a history of at least 24 heavy drinking days during the 90 days prior to screening, based on TLFB.
- Treatment seeking individuals with a treatment goal of achieving abstinence or reducing heavy drinking.
- people able to understand and provide signed informed consent, and able to adhere to the requirements and restrictions of this protocol.
You likely can't join if
- people diagnosed with schizophrenia or chronic psychotic disorder as determined by a licensed clinician according to the DSM-5 criteria, and verified...
- people with present suicidal risk as assessed by the investigator or significant suicide risk based on MADRS item 10 score of 4 or 6, or a history of...
- people who initiated treatment with any of the following medications which are known to effect alcohol consumption, within 30 days of the Screening...
- people with a significant medical illness that is not well controlled (e.g., hepatic impairment, diabetes, hypertension, heart disease, septicemia...
- people experiencing acute alcohol withdrawal. This will be determined using the Clinical Institute Withdrawal Assessment of Alcohol - revised...
- people with a history of epilepsy or seizure (not including history of alcohol withdrawal seizure, ECT induced seizures, or childhood febrile...
See the full eligibility criteria
- Male or female people, 18-86 years old.
- people diagnosed with AUD and who meet criteria for moderate (4-5 out of the 12 symptoms) to severe (\> 6 out of the 12 symptoms) AUD according to the DSM-5 diagnostic criteria as determined by a licensed clinician...
- people who have a history of at least 24 heavy drinking days during the 90 days prior to screening, based on TLFB.
- Treatment seeking individuals with a treatment goal of achieving abstinence or reducing heavy drinking.
- people able to understand and provide signed informed consent, and able to adhere to the requirements and restrictions of this protocol.
- Satisfactory answers on safety screening questionnaire for transcranial magnetic stimulation.
- people diagnosed with schizophrenia or chronic psychotic disorder as determined by a licensed clinician according to the DSM-5 criteria, and verified with the Mini International Neuropsychiatric Interview (Standard MINI...
- people with present suicidal risk as assessed by the investigator or significant suicide risk based on MADRS item 10 score of 4 or 6, or a history of attempted suicide in the last year.
- people who initiated treatment with any of the following medications which are known to effect alcohol consumption, within 30 days of the Screening visit: acamprosate, baclofen, buprenorphine, disulfiram, gabapentin...
- people with a significant medical illness that is not well controlled (e.g., hepatic impairment, diabetes, hypertension, heart disease, septicemia, active tuberculosis, progressive neoplasm, frequent and severe migraine...
- people experiencing acute alcohol withdrawal. This will be determined using the Clinical Institute Withdrawal Assessment of Alcohol - revised (CIWA-Ar) wherein people with a value of \>7 will not be permitted to receive...
- people with a history of epilepsy or seizure (not including history of alcohol withdrawal seizure, ECT induced seizures, or childhood febrile seizures).
- Individuals with a first-degree relative family history of seizure.
- people with a high risk for severe violence or suicidality as assessed during the screening interview.
- Conductive, ferromagnetic or other magnetic-sensitive metals implanted in the head (outside the mouth) or within 10 cm of the treatment coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or...
- people with cardiac pacemakers or active implantable electrodes/neurostimulators within 30 cm of the treatment coil.
- people with a significant neurological disorder or insult including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- Dementia
- Mini Mental State Exam score of less than or equal to 24
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- people suffering from significant hearing loss.
- Previous treatment with TMS within one year.
- Subject's motor threshold cannot be located or is \> 58%.
- Participation in another clinical investigation in which a device or drug has been used within 4 weeks of screening.
- If participating in psychotherapy, subject is not in stable treatment for at least 3 months prior to entry into the study or anticipates a change in the frequency of therapeutic sessions, or the therapeutic focus over...
- Known or suspected pregnancy or planning to become pregnant.
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
The study team makes the final eligibility decision.
Where it's taking place
- Tuscaloosa, Alabama, United States
- La Jolla, California, United States
- West Palm Beach, Florida, United States
- Chicago, Illinois, United States
- Woodbury, New York, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- South Charleston, West Virginia, United States
- Beersheba, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 86 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tuscaloosa, Alabama, United States; La Jolla, California, United States; West Palm Beach, Florida, United States; Chicago, Illinois, United States; Woodbury, New York, United States; Columbus, Ohio, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.