Alcohol Use Disorder Clinical Trial
Official title:
MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience
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). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.
Status | Recruiting |
Enrollment | 86 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion 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 demonstrated effect50 on TMS-fMRI responses in addiction) - 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. Exclusion Criteria: - 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 subarachnoid hemorrhage - 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 except for stable (1 month) antidepressants/SSRI's. [Note: this criterion is for scientific rather than safety or patient comfort reasons]. - 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 with other affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD at large] - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Percent Heavy Drinking Days (PHDD) from baseline | The primary outcome analysis will examine the TMS treatment effect (active vs. sham) on drinking outcomes-measured as percent heavy drinking days (PHDD) (heavy drinking day defined as 4 or more drinks for women and 5 or more drinks for men)-in the follow-up period beginning after the final treatment session. Collected via timeline follow back (TLFB) in three 28-day (month) intervals, this will be analyzed using multivariate mixture models to consider the effect of time (month after treatment) and the interaction of treatment with time, baseline drinking, number of treatment sessions received, and any other potential covariates (e.g., age, nicotine use, time since last drink). Drinking data will be collected on all randomized participants, irrespective of treatment completion. Lower percentages indicate fewer heavy drinking days in the 28-day interval. | Baseline (Week 1), Post-treatment (4-weeks from baseline), 1-month post treatment (Follow-up #1), 2-months post treatment (Follow-up #2), 3-months post treatment (Follow-up #3) | |
Primary | Change in Percent Days Abstinent (PDA) from baseline | The primary outcome analysis will examine the TMS treatment effect (active vs. sham) on drinking outcomes-measured as percent days abstinent (PDA) - in the follow-up period beginning after the final treatment session. Collected via timeline follow back (TLFB) in three 28-day (month) intervals, this will be analyzed using multivariate mixture models to consider the effect of time (month after treatment) and the interaction of treatment with time, baseline drinking, number of treatment sessions received, and any other potential covariates (e.g., age, nicotine use, time since last drink). Drinking data will be collected on all randomized participants, irrespective of treatment completion. Higher percentages indicate increased days abstinent from alcohol in the 28-day interval. | Baseline (Week 1), Post-treatment (4-weeks from baseline), 1-month post treatment (Follow-up #1), 2-months post treatment (Follow-up #2), 3-months post treatment (Follow-up #3) | |
Primary | Change in alcohol cue task MRI activation 1-week post treatment from baseline | For the alcohol cue reactivity task, multivariate mixture model analyses will be used to calculate the difference in activation between the ALC and BEV blocks for vmPFC and ventral striatal ROIs, and to analyze maximum likelihood estimates for ALC vs. BEV activation as a function of time, treatment, and the cross-level interactions of these factors. Specifically, the cue task stimuli will be nested within time (post- vs. pre-treatment scan); time will be nested within participant; and participants will be nested within treatment (Sham vs. Active). | Baseline (Week 1), Post-treatment (4-weeks from baseline) | |
Secondary | Change in anxiety via State-Trait Anxiety Inventory from baseline | As an exploratory analysis, anxiety will be measured using the State-Trait Anxiety Inventory to assess the impact of treatment on self-reported comorbid affective psychopathology. Scoring ranges from 20-80 for each subscale, with higher scores indicating higher anxiety symptoms. | Baseline (Week 1), Post-treatment (4-weeks from baseline), 1-month post treatment (Follow-up #1), 2-months post treatment (Follow-up #2), 3-months post treatment (Follow-up #3) | |
Secondary | Change in alcohol use via Obsessive-Compulsive Drinking Scale from baseline | As an exploratory analysis, alcohol craving will be measured using the Obsessive-Compulsive Drinking Scale to assess the impact of treatment on self-reported obsessive-compulsive aspects of craving. Scoring ranges from 0-40, with 0 indicating a higher ability to control drinking. This questionnaire also includes an obsessive sub-scale and a compulsive sub-scale each ranging from 0-20, with lower scores indicating lower aspects of alcohol craving and higher ability to control these urges. | Baseline (Week 1), Post-treatment (4-weeks from baseline), 1-month post treatment (Follow-up #1), 2-months post treatment (Follow-up #2), 3-months post treatment (Follow-up #3) | |
Secondary | Change in depression via Becks Depression Inventory-II from baseline | As an exploratory analysis, depression will be measured using the Becks Depression Inventory-II to assess the impact of treatment on self-reported comorbid affective psychopathology. Scoring ranges from 0-63, with higher scores indicating higher levels of depressive symptoms. | Baseline (Week 1), Post-treatment (4-weeks from baseline), 1-month post treatment (Follow-up #1), 2-months post treatment (Follow-up #2), 3-months post treatment (Follow-up #3) | |
Secondary | Change in alcohol use via Alcohol Audit from baseline | As an exploratory analysis, alcohol severity will be measured using the Alcohol AUDIT assessment to assess the impact of treatment on self-reported alcohol severity. Scoring ranges from 0-40, with 40 indicating a higher risk of alcohol severity. | Baseline (Week 1), Post-treatment (4-weeks from baseline), 1-month post treatment (Follow-up #1), 2-months post treatment (Follow-up #2), 3-months post treatment (Follow-up #3) | |
Secondary | Changes in cognitive performance from baseline | Individual domains of the cognitive test battery will be tested as well as a linear composite to ascertain potential effects in specific domains as well as broader cognitive function. The same multivariate mixture model analyses will be performed on a composite measure of neurocognitive behavioral performance (assessed at baseline and end of treatment phase) to assess whether the TMS treatment affects neurocognitive performance. | Baseline (Week 1), Post-treatment (4-weeks from baseline) | |
Secondary | Changes in Snaith-Hamilton Pleasure Scale from baseline | The same multivariate mixture model analyses will be performed on the Snaith-Hamilton Pleasure Scale assessed weekly during treatment to examine whether hedonic tone/natural reward responsivity is influenced by active TMS. | Baseline (Week 1), Weekly throughout treatment (Weeks 1-4), Post-treatment (4-weeks from baseline) |
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