ITBS for Alcohol Use Disorder

Not Applicable

Not yet recruiting

• Conditions: Alcohol Use Disorder (AUD)

• Registration Number: NCT06696365
• Lead Sponsor: Nicholas Balderston, PhD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Study Start: 2025-04-30
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged >21and <75
4. Right-handed
5. 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.
6. Ability to obtain an MT at the first session.
7. 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

1. Age <21 or >75 years.
2. Women who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.
3. 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.
4. Have a cardiac pacemaker.
5. Have an implanted device or metal in the brain.
6. Have a cochlear implant.
7. Have a current amnestic disorder, delirium, or other cognitive disorder.
8. Previous treatment with TMS.
9. Left-handed
10. Suicidal ideation within the past month, or history of suicide attempt(s) within the past year.
11. Active psychosis or history of severe psychiatric disorder with psychosis or unstable or untreated psychiatric disorder with potential for psychosis.
12. Abnormal physical exam findings, vital signs (blood pressure, heart rate, respiratory rate, body temperature), EKG measurements, and safety lab values that are deemed clinically significant by a study physician.
13. Diagnoses of severe depression or bipolar disorder.
14. Anyone who in the opinion of the principal investigator (PI) or study physician would not be appropriate for participation (i.e., behavioral issues during clinical treatment, clinical needs outweighing research participation).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cue-evoked prefrontal cortex activity	24 hours before first iTBS session and 24 hours after last iTBS session	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 magnitude of this signal (absorption factor) will be calculated for the conditions described above.

Secondary Outcome Measures

Name	Time	Method
Risk-taking	24 hours before first iTBS session and 24 hours after last iTBS session	The Balloon Analog Risk Task (BART) will be used to measure risk-taking behavior. Participants are presented with virtual balloons that they must blow up, but not pop. The more they fill their virtual balloons, the greater the reward. However, if the balloon pops, they lose their rewards. The primary measure of this task it the average number of pumps per balloon, which is a measure of their risk-taking behavior.
Impulsiveness	24 hours before first iTBS session and 24 hours after last iTBS session	The Go/No Go task will be used to measure impulsiveness. Participants are given a series of trials where they are required to respond to the go stimuli and withhold a response to the no-go stimuli. Performance on this task will be assessed by comparing their accuracy on the go trials to their accuracy on the no-go trials using d-prime (Hits - False alarms), which is associated with impulsive responding on the no-go trials.

Trial Locations

Locations (1)

Caron Treatment Centers; 🇺🇸 Wernersville, Pennsylvania, United States