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NCT06696365
iTBS for Alcohol Use Disorder
NA trial testing TMS in Alcohol Use Disorder (AUD) in 42 participants. Currently enrolling.
1 February 2027
Quick facts
| Lead sponsor | Nicholas Balderston, PhD |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 18 July 2025 |
| Primary completion | 1 February 2027 |
| Estimated completion | 1 February 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- TMS — full drug profile →
Conditions studied
- Alcohol Use Disorder (AUD) — all drugs for Alcohol Use Disorder (AUD) →
Sponsor
Nicholas Balderston, PhD
Who can join
Adults 21 to 75, any sex, with Alcohol Use Disorder (AUD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06696365
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Other recruiting trials for Alcohol Use Disorder (AUD)
Currently open trials in the same condition.
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- NCT07040592 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide · Phase 2 · recruiting
- NCT06949423 — Assessing the Impact of dTMS on Neural Targets Associated With Alcohol Use Disorder · NA · recruiting
- NCT06070649 — The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD) · Phase 1 · recruiting
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Other Nicholas Balderston, PhD trials
Trials by the same sponsor.
- NCT05322239 — Resting State Changes Following Theta Burst Stimulation · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06696365 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nicholas Balderston, PhD
- Last refreshed: 24 July 2025
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