RECRUITING

Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder

Talk to us

Conditions

Alcohol Use DisorderAlcohol AbuseAlcoholismDrinking BehaviorDrinking ProblemTranscranial Magnetic StimulationVeteransNeuroimagingRelapse

Quick Navigation

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

Alcohol Use Disorders are currently positioned as the third leading cause of preventable death in the United States, constituting a humanitarian crisis with substantial financial burden on society and medical facilities. While several pharmacological interventions exist, 60% of individuals who seek these treatments relapse to alcohol within 6 months. These high relapse rates are due in part to elevated brain response to alcohol cues in the environment. This study seeks to evaluate the efficacy of one session of functional Magnetic Resonance Imaging (fMRI) guided transcranial magnetic stimulation (TMS) as a strategy to reduce brain reactivity to alcohol cues.

Official Title

Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder

Quick Facts

Study Start:2025-08-01
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06415721

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:25 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between age 25 and 75.
  2. * Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms).
  3. * Able to attend scheduled clinic visits
  4. * Able to read, understand and voluntarily sign Informed Consent prior to participating in any study-specific procedures or assessments.
  5. * If on a medication regimen, that regimen will be stable for the duration of the study;
  6. * Fluency in English.
  1. * Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/objected in the head and body within 30 cm of the treatment coil.
  2. * General medical condition, disease or neurological disorder that interferes with the assessments or participation.
  3. * Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.
  4. * Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.
  5. * Have a mass lesion, cerebral infarct, or other active CNS disease, including an alcohol-related seizure or a seizure disorder. • A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.
  6. * Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols. • Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).
  7. * Taking benzodiazepine or neuroleptic medications, or any medication known to alter seizure threshold
  8. * unstable chronic illness.
  9. * Current or lifetime history of bipolar disorder or psychosis.
  10. * Participation in another concurrent intervention based clinical trial.

Contacts and Locations

Study Contact

Daniel McCalley
CONTACT
650-493-5000
mccalled@stanford.edu

Principal Investigator

Daniel McCalley, PhD
PRINCIPAL_INVESTIGATOR
Palo Alto VA Health Care System

Study Locations (Sites)

VA Palo Alto Health Care System
Palo Alto, California, 94304
United States

Collaborators and Investigators

Sponsor: VA Palo Alto Health Care System

  • Daniel McCalley, PhD, PRINCIPAL_INVESTIGATOR, Palo Alto VA Health Care System

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 Date2025-08-01
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • Transcranial Magnetic Stimulation
  • Veterans
  • Neuroimaging
  • Relapse

Additional Relevant MeSH Terms

  • Alcohol Use Disorder
  • Alcohol Abuse
  • Alcoholism
  • Drinking Behavior
  • Drinking Problem