Recruiting

Intermittent Theta Burst Stimulation for Inpatient Alcohol Use Disorder

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What is being tested

TMS

Device
Who is being recruted

Alcoholism+2

+ Mental Disorders

+ Substance-Related Disorders

From 21 to 75 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorNicholas Balderston, PhD
Study ContactErin Deneke, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 18, 2025

Actual date on which the first participant was enrolled.

This study explores a new treatment method called intermittent theta-burst stimulation (iTBS) for people with alcohol use disorder who are in inpatient treatment. It aims to see if iTBS can bring about changes in behavior compared to the usual treatment methods. Additionally, it looks at whether iTBS can lower the chances of relapse four months after treatment. The research is important because it seeks to improve current treatment approaches by potentially offering a quicker and possibly more effective therapy option within the typical inpatient treatment duration. Participants in the study are divided randomly into two groups: one receiving iTBS and the other receiving a sham treatment, which acts as a control. The iTBS treatment involves short bursts of magnetic stimulation to a specific brain area, the left dorsal lateral prefrontal cortex, over five days. Participants are exposed to alcohol-related cues before and during the treatment to measure brain responses. The study evaluates changes in brain activity using functional near-infrared spectroscopy, which helps track reactions to alcohol cues and measures related to risk-taking and impulsivity. The goal is to understand whether iTBS can create significant changes in these brain responses, which could indicate a reduction in behaviors linked to alcohol use. Risks are not specified, but the study is designed to fit within a standard 28-day treatment period, making it a convenient option for participants.

Official TitleIntermittent Theta Burst Stimulation (iTBS) as a Treatment for Alcohol Use Disorder in Inpatient Treatment
NCT06696365
Principal SponsorNicholas Balderston, PhD
Study ContactErin Deneke, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlcoholismMental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced Disorders

Criteria

7 inclusion criteria required to participate
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
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14 exclusion criteria prevent from participating
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.
Diagnoses of severe depression or bipolar disorder.
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).
Age <21 or >75 years.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
The intermittent theta burst (iTBS) will be delivered using the MagVenture MagPro X100 stimulator equipped with a Cool B-70 A/P (combined active \& sham) figure of eight coil. Treatment will be at 100% of MT. Treatment will be approximately 2 ½ minutes long. Each session will be 2-hours in length and consist of four treatments spaced 30 minutes apart. There will be a total of five sessions over the course of five to seven days.

Group II

Sham
The B70 A/P coil is also equipped with an active sham electric stimulation (e-stim) system that delivers a small current pulse synchronous to the TMS pulse, titrated to match the TMS sensations. This pulse is similar in duration and distribution to the current induced by the TMS pulse . This pulse will be delivered to the scalp adjacent to the stimulation site via disposable low-profile webbed EEG electrodes filled with electrolytic gel. Electrodes will be connected to the e-stim system via one of two identical cables allowing the operator to deliver either real or sham electric stimulation. Cables will be labeled to match the corresponding coil side so that each session always includes either active TMS or active e-stim, but never both.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Caron Treatment Centers

Wernersville, United StatesOpen Caron Treatment Centers in Google Maps
Recruiting
One Study Center