Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorVA Palo Alto Health Care System
About this trial
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.
Eligibility criteria
Qualifiers
Between age 25 and 75.
Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms).
Able to attend scheduled clinic visits
Able to read, understand and voluntarily sign Informed Consent prior to participating in any study-specific procedures or assessments.
Disqualifiers
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.
General medical condition, disease or neurological disorder that interferes with the assessments or participation.
Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.
Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.
Trial design
Treatments tested in this trial
- Active Transcranial Magnetic Simulation
- Sham
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
VA Palo Alto Health Care System
Lead sponsor
Stanford University
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov