NCT03291431

Intermittent Theta Burst for the Treatment of Alcohol Use Disorders in Veterans

Intermittent Theta Burst TMS for the Treatment of Alcohol Use Disorders in Veterans

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of intermittent theta burst repetitive transcranial magnetic stimulation (iTBS) as a treatment for Veterans with an alcohol use disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition. iTBS has demonstrated equivalent efficacy and safety to repetitive transcranial magnetic stimulation employing 10Hz stimulation protocols in treatment of depressive disorders. The advantage of iTBS is that it can be delivered in approximately 5 minutes where conventional 10Hz repetitive transcranial magnetic stimulation (rTMS) protocols are typically 20-25 minutes. It is hypothesized that Veterans with AUD who receive active iTBS applied to the left dorsolateral prefrontal cortex (DLPFC), compared to controls (i.e., Veterans with AUD who receive sham iTBS), will show significant decreases alcohol craving, depressive symptomatology and cigarette consumptions, as well as improved neurocognition, a longer period of abstinence, and a lower overall rate of relapse over 6 months following standard psychosocial treatment for AUD at VA substance treatment clinics. In exploratory analyses, it is also predicted that magnetic resonance measures of left DLPFC glutamate concentration, volume of anterior frontal cortical brain regions, and performance on fMRI tasks interrogating the function of the salience/reward circuits will serve as biomarkers of iTBS treatment response. The goal of this proposal is to implement treatment that effectively promotes sustained abstinence in Veterans with AUD, given long-term abstinence is related to optimal neurobiological, neuropsychological and psychosocial recovery and functioning.

Conditions

• Alcohol Use Disorder
• Depressive Disorder
• Cigarette Smoking

Interventions

Type	Name	Description
DEVICE	Intermittent theta burst transcranial magnetic stimulation	20 iTBS sessions (active or sham) administered over the course of 2 weeks

Timeline

• Start date: 2017-12-01
• Primary completion: 2022-01-30
• Completion: 2022-07-30
• First posted: 2017-09-25
• Last updated: 2023-10-16
• Results posted: 2023-06-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study