Using brain stimulation to reduce alcohol consumption in people seeking treatment

Theta Burst Stimulation as a Tool to Decrease Drinking in Treatment-seeking Alcohol Users

This study is testing whether a non-drug brain stimulation technique can help people with Alcohol Use Disorder drink less and stay sober.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 21 Years to 75 Years
• Sex: All
• Sponsor: Wake Forest University Health Sciences (other)
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT04154111 on ClinicalTrials.gov

What this trial studies

This study investigates the use of transcranial magnetic stimulation (TMS) as a non-drug approach to help individuals with Alcohol Use Disorder (AUD) reduce their drinking behavior. Participants will undergo different TMS strategies targeting specific brain regions to assess their effectiveness in decreasing alcohol cravings and improving abstinence rates over a four-month period. The research aims to enhance treatment outcomes by modulating neural circuits involved in decision-making related to alcohol use. The findings could lead to the development of a new evidence-based treatment protocol for AUD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 75 who meet the criteria for Alcohol Use Disorder and are seeking treatment.

Not a fit: Patients with current severe mental health issues, such as schizoaffective disorder or those using certain psychoactive substances, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel, non-pharmacological treatment option for individuals struggling with alcohol dependence.

How similar studies have performed: Other studies have shown promise in using brain stimulation techniques for addiction treatment, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria

1. Age 21- 75.
2. Meets the DSM V criteria for having a current AUD, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V.
3. Has an AUDIT score above 8 (such that they are at least Medium Risk drinkers according to criteria).

Exclusion Criteria:

1. Any psychoactive substance use (except marijuana and nicotine) within the last 30 days by self-report.
2. Meets DSM V criteria for schizoaffective disorder. \[Note: The inclusion of subjects with 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.
3. Has current suicidal ideation or homicidal ideation.
4. Is currently taking or initiates a medication known to affect alcohol intake and/or craving (e.g., disulfiram. naltrexone, acamprosate, topiramate). \[Note: This exclusionary criterion is for scientific rather than safety or patient comfort reasons\].
5. Expects a change in their medical history in the next 6 months that would impair their participation in this study \[e.g. expected medical procedure, planned pregnancy, initiation of new medication\].
6. Females of childbearing potential who are pregnant (by urine HCG), planning to become pregnant, nursing, or who are not using a reliable form of birth control.
7. Suffers from chronic migraines (more than 50% of the days in a month).
8. Does not meet safety criteria for MRI and TMS
9. Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold and has had a change in their medication).
10. Is currently enrolled in another form of treatment for alcohol use disorder (This is for scientific reasons to clarify the role of TMS as a treatment agent)
11. History of traumatic brain injury resulting in hospitalization, loss of consciousness for more than 10 minutes, and/or having ever been informed he/she has an epidural, subdural, or subarachnoid hemorrhage.
12. Not able to read and understand questionnaires, assessments, and the informed consent.
13. Clinical Intake Withdrawal Assessment (CIWA) \>5 (to prevent delivering TMS to individuals in withdrawal.

Where this trial is running

Winston-Salem, North Carolina

• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Merideth A Addicott, PhD — Wake Forest University Health Sciences
• Study coordinator: Merideth A Addicott, PhD

Conditions: Alcohol Use Disorder, Alcohol Abuse, Alcohol Dependence, Craving, Transcranial Magnetic Stimulation, Brain Stimulation, Treatment, Neuroimaging