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NCT06696365 · ClinicalTrials.gov registry record · NA
iTBS for Alcohol Use Disorder
A NA study of Alcohol Use Disorder (AUD), sponsored by Nicholas Balderston, PhD.
- Recruiting
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT06696365 is a NA study of Alcohol Use Disorder (AUD) that is actively recruiting participants, run by Nicholas Balderston, PhD. The registered enrollment target is 42 participants, below the 1,823-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06696365, a NA study of Alcohol Use Disorder (AUD), is actively recruiting participants, sponsored by Nicholas Balderston, PhD.
- RECRUITING
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE TMS
Study Locations (1)
Pennsylvania
- Caron Treatment Centers - Wernersville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2025-07-18 |
| Est. Completion | 2027-02-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06696365
The ClinicalTrials.gov registry entry for NCT06696365 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,823-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (98% lower). The listed sponsor is Nicholas Balderston, PhD, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alcohol Use Disorder (AUD) appearing as the primary indexed condition, and to 1 intervention - of which TMS is the first listed.
NCT06696365 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06696365 about?
NCT06696365 is a clinical study titled "iTBS for Alcohol Use Disorder". 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...
What is the current status of trial NCT06696365?
This trial is currently recruiting. It is a NA study. The enrollment target is 42 participants. The study started on 2025-07-18. Estimated completion is 2027-02-01.
What conditions does trial NCT06696365 study?
This clinical trial studies the following conditions: Alcohol Use Disorder (AUD).
What interventions are being tested in trial NCT06696365?
The interventions under investigation include: TMS (DEVICE).
Who is sponsoring clinical trial NCT06696365?
This trial is sponsored by Nicholas Balderston, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06696365 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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