Theta Burst Stimulation for Alcohol Use Disorder

NCT06060496 | Completed Results FDA Device

• 2 other identifiers: 868532P30CA177558-11
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alcohol Use Disorder

Keywords

Transcranial magnetic stimulation (TMS)

Outcome Measures

Primary Outcomes (2)

• Change in Penn Alcohol Craving Scale

  Craving measured using the Penn alcohol craving scale (PACS) that has five items and is rated on a scale of 1 to 6. Minimum score is 1 and maximum score is 30. Higher score equates to increased craving

  Before and after two cTBS sessions, approximately 2 hours

• Change in Alcohol Cue Attentional Bias

  Fixation time on alcohol cues measured using an eye tracker in milliseconds. Higher score indicates greater attentional bias.

  Before and after two cTBS sessions, approximately 2 hours

Secondary Outcomes (1)

• Resting State Functional Connectivity

  Before and after two cTBS sessions, approximately 2 hours

Study Arms (1)

Active cTBS and sham cTBS

EXPERIMENTAL

There is only one arm in this study and all participants in this arm will receive 2 interventions: active and sham cTBS in a within subject blinded fashion. They will first receive active cTBS and then sham cTBS, separated by four weeks to minimize carryover effects.

Device: Active cTBS; Device: Sham cTBS

Interventions

Active cTBS DEVICE

Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes

Also known as: Continuous theta burst stimulation

Active cTBS and sham cTBS

Sham cTBS DEVICE

Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes

Also known as: Continuous theta burst stimulation

Active cTBS and sham cTBS

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients seen at a clinic within the University of Kentucky Healthcare
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gopalkumar Rakesh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

245 Fountain Court

Lexington, Kentucky, 40513, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Gopalkumar Rakesh, MD
• Organization: University of Kentucky

gopalkumar.rakesh@uky.edu

8592579402

Study Officials

• Gopalkumar Rakesh, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Using the MagVenture A/P coil
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: October 1, 2023
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-04

Locations

US (1)