Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

At least 60% of those with AUD will experience a major relapse period within 6 months of treatment, irrespective of the intervention (psychosocial and/or pharmacological) employed. Consequently, the high prevalence of AUD and relapse following treatment in Veterans is associated with substantial resource allocation and costs for the VA Health Care System. Current pharmacological and psychosocial interventions demonstrate only a moderate level of efficacy, which is reflected in the high rate of relapse in AUD. Transcanial Magnetic Stimulation (TMS) is a neurostimulation method that is at the forefront of innovative, non-invasive, and safe treatments for AUD, and other psychiatric disorders. To reduce the high rate of relapse in Veterans with AUD, it is necessary for interventions to more effectively address the associated neurobiological dysfunction. Non-invasive neuromodulation techniques are showing promise toward the aim of modifying specific and selective neural targets related to AUD and relapse. To date, TMS has been primarily delivered to the dorsolateral and medial prefrontal cortices as these regions are, on average, highly reactive to alcohol cues. On an individual basis, however, peak brain response to alcohol cues can vary substantially in spatial location within the brain. Retrospective analyses of TMS-AUD clinical trails has demonstrated that when TMS is delivered to an individual's peak brain response to alcohol cues, the likelihood of remaining abstinent is increased by a factor of 5.6 (relative to sham TMS treatment). This study aims to deliver one session of TMS to a cortical target which displays peak functional connectivity to the ventral striatum, a key brain region mediating reward and alcohol cue reactivity. The ultimate goal of this study evaluate change in brain reactivity to alcohol cues following active and sham TMS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06415721
Study type	Interventional
Source	VA Palo Alto Health Care System
Contact
Status	Not yet recruiting
Phase	N/A
Start date	July 1, 2024
Completion date	January 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04788004` - Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
Recruiting	`NCT05684094` - Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function	N/A
Completed	`NCT03406039` - Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems	N/A
Completed	`NCT03573167` - Mobile Phone-Based Motivational Interviewing in Kenya	N/A
Completed	`NCT04817410` - ED Initiated Oral Naltrexone for AUD	Phase 1
Active, not recruiting	`NCT04267692` - Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders	N/A
Completed	`NCT03872128` - The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders	Phase 1
Completed	`NCT02989662` - INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers	Phase 1/Phase 2
Recruiting	`NCT06030154` - Amplification of Positivity for Alcohol Use	N/A
Active, not recruiting	`NCT05419128` - Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19	N/A
Completed	`NCT04564807` - Testing an Online Insomnia Intervention	N/A
Completed	`NCT04284813` - Families With Substance Use and Psychosis: A Pilot Study	N/A
Completed	`NCT04203966` - Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
Recruiting	`NCT05861843` - Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
Terminated	`NCT04404712` - FAAH Availability in Psychiatric Disorders: A PET Study	Early Phase 1
Enrolling by invitation	`NCT04128761` - Decreasing the Temporal Window in Individuals With Alcohol Use Disorder	N/A
Not yet recruiting	`NCT06163651` - Evaluating a One-Year Version of the Parent-Child Assistance Program	N/A
Not yet recruiting	`NCT06444243` - Psilocybin-assisted Therapy for Alcohol Use Disorder	Phase 2
Not yet recruiting	`NCT06337721` - Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults	N/A
Enrolling by invitation	`NCT02544581` - Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare	N/A