Trial Outcomes & Findings for Theta Burst Stimulation for Alcohol Use Disorder (NCT NCT06060496)

Last Updated: 2025-05-06

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

Before and after two cTBS sessions, approximately 2 hours

Results posted on

2025-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Active cTBS and Sham cTBS 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. Active cTBS: Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes Sham cTBS: Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes
Overall Study STARTED	8
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Active cTBS and Sham cTBS 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. Active cTBS: Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes Sham cTBS: Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

Theta Burst Stimulation for Alcohol Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active cTBS and Sham cTBS n=8 Participants 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. Active cTBS: Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes Sham cTBS: Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Before and after two cTBS sessions, approximately 2 hours

Outcome measures

Outcome measures
Measure	cTBS and Sham cTBS n=4 Participants All participants received both cTBS and sham cTBS in a within subject design
Change in Penn Alcohol Craving Scale Baseline_cTBS	11.50 units on a scale Standard Deviation 9.68
Change in Penn Alcohol Craving Scale After second session_cTBS	11.75 units on a scale Standard Deviation 9.43
Change in Penn Alcohol Craving Scale Baseline_sham cTBS	8.25 units on a scale Standard Deviation 5.44
Change in Penn Alcohol Craving Scale After second session_sham cTBS	7.25 units on a scale Standard Deviation 6.70

PRIMARY outcome

Timeframe: Before and after two cTBS sessions, approximately 2 hours

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

Outcome measures

Outcome measures
Measure	cTBS and Sham cTBS n=4 Participants All participants received both cTBS and sham cTBS in a within subject design
Change in Alcohol Cue Attentional Bias Baseline_cTBS	294.92 milliseconds Standard Deviation 667.18
Change in Alcohol Cue Attentional Bias After second session_cTBS	459.60 milliseconds Standard Deviation 1618.57
Change in Alcohol Cue Attentional Bias Baseline_sham cTBS	355.3 milliseconds Standard Deviation 659.06
Change in Alcohol Cue Attentional Bias After second session_sham cTBS	666.30 milliseconds Standard Deviation 1592.36

SECONDARY outcome

Timeframe: Before and after two cTBS sessions, approximately 2 hours

Number of participants with resting state functional connectivity scans acquired before and after cTBS and sham cTBS

Outcome measures

Outcome measures
Measure	cTBS and Sham cTBS n=4 Participants All participants received both cTBS and sham cTBS in a within subject design
Resting State Functional Connectivity	4 Participants

Adverse Events

cTBS and Sham cTBS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gopalkumar Rakesh, MD

University of Kentucky

Phone: 8592579402

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place