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Clinical Trial

iTBS for Alcohol Use Disorder

NCT: NCT06696365 · TERMINATED

NCT IDNCT06696365
StatusTERMINATED
Start Date2025-07-18
Completion2026-04-08

Brief Summary

The two primary objectives of this study are to test whether intermittent theta-burst (iTBS) can affect behavioral change as compared to treatment as usual (TAU, sham) in individuals with alcohol use disorder (AUD) in inpatient substance use treatment. The secondary objective is to determine whether iTBS reduces the risk for relapse at four months compared to sham. It is hypothesized that individuals who receive iTBS treatment will show attenuated prefrontal cortex (PFC) CNS responses to alcohol related cues and reductions in risk-taking behavior and impulsivity as measured by PFC responses measured by functional near infrared spectroscopy (fNIRs). The proposed approach will be to measure the effect of iTBS treatment on PFC CNS response. Participants will be randomized to receive 5 days (4 x sessions/day x 600 pulses/session = 12,000 pulses) of iTBS or sham to the left dorsal lateral prefrontal cortex (dlPFC) while being exposed to alcohol cues five minutes prior to treatment and during treatment. The investigators will target the Beam/F3 scalp location and use the TMS Navigator Research Premium stereotaxic system for neuronavigation. PFC response data will be gathered using fNIRs measuring cue reactivity, risk-taking (Balloon Analog Risk Test), and impulsiveness (Go No Go task). The primary outcomes will be the mean changes in pre-post PFC response data gathered using the fNIRs sessions. The rationale for this approach is that TBS can be delivered over a shorter time frame than rTMS and may require fewer sessions, allowing for a better fit within a 28-day inpatient treatment stay.

Frequently Asked Questions

What is iTBS for Alcohol Use Disorder?

iTBS for Alcohol Use Disorder is a clinical trial registered under NCT06696365. Current status: TERMINATED.

What is the status of NCT06696365?

The current status of NCT06696365 (iTBS for Alcohol Use Disorder) is: TERMINATED.

When did iTBS for Alcohol Use Disorder start?

iTBS for Alcohol Use Disorder started on 2025-07-18.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.