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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: Recruiting NA study of Alcohol Use Disorder (AUD), sponsored by Nicholas Balderston, PhD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Individuals will undergo a cue reactivity task composed of four stimulus categories: general alcohol cues; alcohol cues specific to patient alcohol choice preferences; natural reward cues; and emotionally neutral cues (e.g., pictures of everyday objects like lamps, pens) will be monitored with Functional near-infrared spectroscopy (fNIRS) over the prefrontal cortex. fNIRS measures the amount of infrared light absorbed by the brain, which differs as a function of ongoing brain activity. The magni
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 |
What NCT06696365 shows while recruiting
NCT06696365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,823-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder (AUD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06696365's enrollment target sits among peer trials
42 23rd of 30 higher than 8 of 30 other Alcohol Use Disorder (AUD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder (AUD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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