ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

There is growing interest in the utilization of transcranial magnetic stimulation (TMS) as a novel, non-pharmacologic approach to decreasing alcohol use among treatment-seeking individuals with Alcohol Use Disorder (AUD). The results of this study will be used to determine which of the 2 proposed TMS strategies has a larger effect on drinking behavior (% days abstinent, % heavy drinking days) as well as alcohol cue-reactivity in a 4 month period. These data will pave the way for TMS to be used as an innovative, new treatment option for individuals with AUD.

Official Title

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

Quick Facts

Study Start:2020-05-26

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04154111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

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.

Contacts and Locations

Principal Investigator

Merideth A Addicott, PhD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Merideth A Addicott, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-05-26

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2020-05-26

Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

Transcranial Magnetic Stimulation
Brain Stimulation
Treatment
Neuroimaging

Additional Relevant MeSH Terms

Alcohol Use Disorder
Alcohol Abuse
Alcohol Dependence
Craving