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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
Caron Treatment Centers
RECRUITING
Wernersville
Contact Information
Primary
Erin Deneke, PhD
EDeneke@caron.org
610-743-6242
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 42
Treatments
Experimental: Active iTBS
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.
Sham_comparator: Sham iTBS
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.
Related Therapeutic Areas
Sponsors
Leads: Nicholas Balderston, PhD

This content was sourced from clinicaltrials.gov