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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
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. MagVenture MagPro X100 is available commercially and has been FDA approved to treat major depressive disorder and obsessive-compulsive disorder.
Caron Treatment Centers
Wernersville, Pennsylvania, United States
Cue-evoked prefrontal cortex activity
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.
Time frame: 24 hours before first iTBS session and 24 hours after last iTBS session
Risk-taking
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.
Time frame: 24 hours before first iTBS session and 24 hours after last iTBS session
Impulsiveness
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.
Time frame: 24 hours before first iTBS session and 24 hours after last iTBS session
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