Trial Outcomes & Findings for Intermittent Theta Burst for the Treatment of Alcohol Use Disorders in Veterans (NCT NCT03291431)

Last Updated: 2023-10-16

Results Overview

Number of particiants in active vs. sham who maintained completed abstinence from alcohol/substance over 6 months post final rTMS session.

Recruitment status

TERMINATED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

6 months

Results posted on

2023-10-16

Participant Flow

From 20MAR20-31AUG21 no participants were recruited due the mandatory hiatus of recruitment of human participants (forced by the COVID-19 pandemic) and the Principal Investigator's mobilization to active military service. The PI discussed the recruitment issues with the Stanford NeuroChoice Initiative funding agency, and it was decided to discontinue recruitment in JUL21.

Participant milestones

Participant milestones
Measure	Active iTBS Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks	Sham iTBS Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks
Overall Study STARTED	8	9
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Active iTBS Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks	Sham iTBS Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks
Overall Study Protocol Violation	2	1
Overall Study Participant self-discharged against medical advice from treatment program during active study phase	1	0
Overall Study Residential treatment team requested participant withdraw due to multiple conflicting appointments.	0	1

Baseline Characteristics

Intermittent Theta Burst for the Treatment of Alcohol Use Disorders in Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active iTBS n=8 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks	Sham iTBS n=9 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks	Total n=17 Participants Total of all reporting groups
Age, Continuous	32.0 years STANDARD_DEVIATION 9.8 • n=5 Participants	48.5 years STANDARD_DEVIATION 12.4 • n=7 Participants	42.3 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Education	13.5 years STANDARD_DEVIATION 1.5 • n=5 Participants	13.3 years STANDARD_DEVIATION 1.8 • n=7 Participants	13.4 years STANDARD_DEVIATION 1.7 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Number of particiants in active vs. sham who maintained completed abstinence from alcohol/substance over 6 months post final rTMS session.

Outcome measures

Outcome measures
Measure	Active iTBS n=8 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks	Sham iTBS n=9 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks
Number of Participants Who Were Abstinent Through Month 6	5 Participants	7 Participants

SECONDARY outcome

Timeframe: baseline and follow-up (approximately 2 weeks)

Population: Participants with available data are included in the analysis.

Left dorsolateral prefrontal region glutamate/creatine ratio pre and post active/sham iTBS. Data were recorded in international units (IU) and converted to Z scores based on the entire sample (unit normal distribution, mean of 0, standard deviation of 1). Higher Z scores (standard deviation above the mean) indicate a greater metabolite concentration ratio and better functioning.

Outcome measures

Outcome measures
Measure	Active iTBS n=4 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks	Sham iTBS n=7 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks
Left Dorsolateral Prefrontal Region Glutamate/Creatine Ratio baseline	0.31 z-score Standard Error 0.29	0.02 z-score Standard Error 0.30
Left Dorsolateral Prefrontal Region Glutamate/Creatine Ratio week 2	0.25 z-score Standard Error 0.29	0.29 z-score Standard Error 0.22

SECONDARY outcome

Timeframe: baseline and follow-up (approximately 2 weeks)

Population: Participants with data available at each respective assessment point.

Left dorsolateral prefrontal cortex thickness pre and post active/sham iTBS; hypothesized that increased thickness corresponds to improved cytoarchitectural integrity of the left dorsolateral prefrontal cortex.

Outcome measures

Outcome measures
Measure	Active iTBS n=8 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks	Sham iTBS n=9 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks
Left Dorsolateral Prefrontal Cortex Thickness Baseline	2.34 mm Standard Deviation 0.14	2.36 mm Standard Deviation 0.15
Left Dorsolateral Prefrontal Cortex Thickness Follow-up	2.39 mm Standard Deviation 0.17	2.37 mm Standard Deviation 0.19

SECONDARY outcome

Timeframe: baseline and follow-up (approximately 2 weeks)

Population: Participants with available data are included in the analysis.

Beck Depression Inventory-II score pre and post active/sham iTBS (score range, 0 to 63, higher scores indicate more severe symptoms).

Outcome measures

Outcome measures
Measure	Active iTBS n=4 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks	Sham iTBS n=7 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks
General Depressive Symptoms Baseline	18.4 score on a scale Standard Error 3.4	18.0 score on a scale Standard Error 3.1
General Depressive Symptoms Follow-up	10.0 score on a scale Standard Error 4.0	11.9 score on a scale Standard Error 2.9

SECONDARY outcome

Timeframe: baseline and follow-up (approximately 2 weeks)

Population: Participants with available data are included in the analysis.

Anhedonic depressive symptoms from Mood and Anxiety Symptom Questionnaire (MASQ, 30-item version; score range: 10 to 50, high scores correspond to more severe symptoms).

Outcome measures

Outcome measures
Measure	Active iTBS n=4 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks	Sham iTBS n=8 Participants Intermittent theta burst transcranial magnetic stimulation: Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks
Anhedonic Depressive Symptoms baseline	29.1 score on a scale Standard Error 2.8	32.7 score on a scale Standard Error 2.6
Anhedonic Depressive Symptoms Follow-up	22.5 score on a scale Standard Error 3.3	30.5 score on a scale Standard Error 2.4

Adverse Events

Active iTBS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham iTBS

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

Dr. Timothy C. Durazzo/Project PI

Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences

Phone: 650-493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place