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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Nov 4, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method called transcranial magnetic stimulation (TMS) to help people who want to reduce their alcohol use. TMS is a non-invasive technique that uses magnetic fields to stimulate nerve cells in the brain. The goal of the study is to find out which of two different TMS strategies is more effective in helping participants drink less over a four-month period. Researchers will look at how many days participants are able to stay sober and how often they engage in heavy drinking.

To participate in this study, individuals must be between 21 and 75 years old and meet specific criteria for having Alcohol Use Disorder (AUD). This includes having a certain score on a drinking assessment test. However, individuals with recent substance use (other than marijuana or nicotine), certain mental health conditions, or those who are pregnant or nursing cannot participate. Participants can expect to receive treatment through TMS sessions and will be monitored throughout the study. This research could lead to new treatment options for those struggling with alcohol use.

Gender

ALL

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.