iTBS for Alcohol Use Disorder (NCT06696365) | Clinical Trial Compass
TerminatedNot Applicable
iTBS for Alcohol Use Disorder
Stopped: Change in staffing at site. Two participants were enrolled. No usable data was collected from these participants.
United States2 participantsStarted 2025-07-18
Plain-language 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.
Who can participate
Age range21 Years – 75 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Male or female, aged \>21and \<75
✓. Right-handed
✓. Diagnosed with an AUD disorder seeking treatment at Caron Treatment Centers and planning to be enrolled in residential treatment for a minimum of 28 days.
✓. Ability to obtain an MT at the first session.
✓. Women of childbearing potential must consent to use a medically accepted method of birth control (e.g., implants, injectables, oral contraceptives, IUD, sexual abstinence, or vasectomized partner) or to abstain from sexual intercourse only during the five treatment days of the study.
Exclusion criteria
✕. Age \<21 or \>75 years.
✕. Women who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.
What they're measuring
1
Cue-evoked prefrontal cortex activity
Timeframe: 24 hours before first iTBS session and 24 hours after last iTBS session
✕. Evidence or history of a significant neurological disorder including moderate-severe head trauma, stroke, Parkinson's disease, or other movement disorder (except benign essential tremor), epilepsy. History of seizures (except juvenile febrile seizures or any condition/concurrent medication that could notably lower seizure threshold. This may include traumatic brain injury (TBI) if the TBI places the individual at an elevated risk of seizure.
✕. Have a cardiac pacemaker.
✕. Have an implanted device or metal in the brain.
✕. Have a cochlear implant.
✕. Have a current amnestic disorder, delirium, or other cognitive disorder.