N/A
N=8
Theta Burst Stimulation for Alcohol Use Disorder
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT06060496 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Change in Penn Alcohol Craving Scale — 11.50; 11.75; 8.25; 7.25 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active cTBS (Device); Sham cTBS (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Gopalkumar Rakesh
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Penn Alcohol Craving Scale |
11.50; 11.75; 8.25; 7.25 | — |
| PRIMARY Change in Alcohol Cue Attentional Bias |
294.92; 459.60; 355.3; 666.30 | — |
| SECONDARY Resting State Functional Connectivity |
4 | — |
Summary
The study will examine the effects of two continuous theta burst stimulation (cTBS) sessions (given in a single day) on resting state functional MRI (fMRI), alcohol cue related attentional bias and alcohol craving in patients with alcohol use disorder (AUD).
Eligibility Criteria
Inclusion criteria.
- Patients seen at a clinic within the University of Kentucky Healthcare
- 21-60 years of age
- male or female gender
- Able to read, understand and communicate in English
- willing to adhere to the general rules of the UK Healthcare
- Must fulfill criteria for moderate alcohol use disorder.
Exclusion criteria
- Positive pregnancy test for females
- traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia
- intracranial metal shrapnel
- previous adverse effect with TMS
- sub-threshold consistency while performing behavioral tasks
- failure to show baseline attentional bias to alcohol versus neutral cues.
Data sourced from ClinicalTrials.gov (NCT06060496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.