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iTBS for Alcohol Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Intermittent Theta Burst Stimulation (iTBS) as a Treatment for Alcohol Use Disorder in Inpatient Treatment

Quick Facts

Study Start:2025-07-18

Study Completion:2027-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06696365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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).

Contacts and Locations

Study Contact

Erin Deneke, PhD

CONTACT

610-743-6242

EDeneke@caron.org

Study Locations (Sites)

Caron Treatment Centers

Wernersville, Pennsylvania, 19565

United States

Collaborators and Investigators

Sponsor: Nicholas Balderston, PhD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-18

Study Completion Date2027-02-01

Study Record Updates

Study Start Date2025-07-18

Study Completion Date2027-02-01

Terms related to this study

Additional Relevant MeSH Terms

Alcohol Use Disorder (AUD)