Trial Outcomes & Findings for Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder (NCT NCT04927364)

NCT ID: NCT04927364

Last Updated: 2025-12-29

Results Overview

Heavy drinking is defined as consuming (in a 24 hour period) 3 or more drinks for women, or 4 or more drinks for men.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-12-29

Participant Flow

Participant milestones

Measure	Active dTMS Participants will receive 30 dTMS treatments, administered 3 times per day over 10 consecutive business days, Each treatment visit will last approximately 30 minutes in total.
Overall Study STARTED	8
Overall Study Received TMS Treatment	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Active dTMS Participants will receive 30 dTMS treatments, administered 3 times per day over 10 consecutive business days, Each treatment visit will last approximately 30 minutes in total.
Overall Study Withdrawal by Subject	3
Overall Study Unable to complete preassessment MRI	1

Baseline Characteristics

Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder

Baseline characteristics by cohort

Measure	Active dTMS n=6 Participants Participants will receive 30 dTMS treatments, administered 3 times per day over 10 consecutive business days, Each treatment visit will last approximately 30 minutes in total.
Age, Categorical <=18 years	0 Participants n=174 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=174 Participants
Age, Categorical >=65 years	0 Participants n=174 Participants
Sex: Female, Male Female	2 Participants n=174 Participants
Sex: Female, Male Male	4 Participants n=174 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=174 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=174 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=174 Participants
Race (NIH/OMB) Asian	0 Participants n=174 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants
Race (NIH/OMB) Black or African American	0 Participants n=174 Participants
Race (NIH/OMB) White	3 Participants n=174 Participants
Race (NIH/OMB) More than one race	0 Participants n=174 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=174 Participants
Region of Enrollment United States	6 Participants n=174 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants who completed at least half of the treatment sessions.

Six months after completing the intervention, participants will be contacted to determine self-reported relapse status. To determine relapse status, participants complete brief standardized measures of alcohol and substance use, Alcohol Timeline Followback (TLFB) and the Brief Addiction Monitor (BAM) questionnaire.

Outcome measures

Measure	Active dTMS n=5 Participants Participants will receive 30 dTMS treatments, administered 3 times per day over 10 consecutive business days, Each treatment visit will last approximately 30 minutes in total.
Number of Participants With Relapse to Alcohol 6 Months After Treatment	3 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants who completed at least half of the treatment sessions.

Abstinence defined as no drinks consumed.

Outcome measures

Measure	Active dTMS n=5 Participants Participants will receive 30 dTMS treatments, administered 3 times per day over 10 consecutive business days, Each treatment visit will last approximately 30 minutes in total.
Percentage of Days Abstinent	85.1 percentage of days Standard Deviation 32.06

PRIMARY outcome

Timeframe: 6 months

Population: Participants who completed at least half of the treatment sessions.

Heavy drinking is defined as consuming (in a 24 hour period) 3 or more drinks for women, or 4 or more drinks for men.

Outcome measures

Measure	Active dTMS n=5 Participants Participants will receive 30 dTMS treatments, administered 3 times per day over 10 consecutive business days, Each treatment visit will last approximately 30 minutes in total.
Percentage of Days of Heavy Drinking	2.7 percentage of days Standard Deviation 5.37

Adverse Events

Active dTMS

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

Claudia Padula

VA Palo Alto Healthcare System

Phone: 650-849-1211

Email: padula@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place