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New treatment option for Alcohol Use Disorder
Official title MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience
ClinicalTrials.gov ID: NCT04998916
What this study is testing
- What it's testing
- The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures).
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- Age 21-65 (to maximize participation; note: Scalp-to-Cortex distance will be included as a covariate to calculate adjusted TMS dose given expected...
- Alcohol Use Disorder, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V
- Consumption of more than 14 drinks (women) or 21 drinks (men) per week, with at least 4 heavy drinking days (defined as ≥ 4 drinks for women and ≥ 5...
- Able to read and understand questionnaires and informed consent.
You likely can't join if
- Has metal placed above the neck
- Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold)
- Has a history of moderate to severe alcohol withdrawal or medicated alcohol withdrawal
- Has a history of claustrophobia
- Has a history of chronic migraines
- Has a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or...
See the full eligibility criteria
- Age 21-65 (to maximize participation; note: Scalp-to-Cortex distance will be included as a covariate to calculate adjusted TMS dose given expected cortical atrophy in heavy alcohol users and older adults and the...
- Alcohol Use Disorder, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V
- Consumption of more than 14 drinks (women) or 21 drinks (men) per week, with at least 4 heavy drinking days (defined as ≥ 4 drinks for women and ≥ 5 for men) per week during the 30-days prior to enrolling.
- Able to read and understand questionnaires and informed consent.
- Has metal placed above the neck
- Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold)
- Has a history of moderate to severe alcohol withdrawal or medicated alcohol withdrawal
- Has a history of claustrophobia
- Has a history of chronic migraines
- Has a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or...
- Has an unstable medical illness requiring planned medical/surgical intervention (e.g. chemotherapy, surgical procedure)
- Medications: Is currently taking or initiates a new prescription for drugs known to improve alcohol drinking treatment outcomes (e.g. naltrexone, acamprosate, topiramate) or taking psychiatric/sleeping medications...
- Has a history of substance use disorder (other than nicotine) by DSM-V criteria in the past 6 months
- Meets DSM V criteria for panic disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia, dissociative disorders, eating disorders, and any other psychotic disorder. [Note: The inclusion of participants...
- Has current suicidal ideation or homicidal ideation
- Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
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 study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. 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.