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

Primary Purpose

Alcohol Use Disorder, Depressive Disorder, Cigarette Smoking

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intermittent theta burst transcranial magnetic stimulation

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring alcohol use disorder, intermittent theta burst, Veterans, depressive disorder, cigarette smoking

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

21-65 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for alcohol use disorder, and alcohol is self-identified as primary substance of misuse.
Actively in treatment at VA Palo Alto HCS Addiction Treatment Service
Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participation in study procedures.

Exclusion Criteria:

History of Schizophrenia Spectrum Disorders, Bipolar Disorders, a
Current substance use disorder that exceeds the severity of the AUD (based on DSM-5 diagnostic criteria)
Current use of an FDA approved medication (i.e., disulfiram, acamprosate, and naltrexone) for treatment of AUD,
Active current suicidal intent or plan (patients with a previous clinical flag for risk for suicide will be required to have an established safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial),
Any form of previous TMS or electroconvulsive treatment.
Thyroid disease,
Unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months
Cerebrovascular accident
Cancer if < 1 year since end of treatment
Unstable diabetes
COPD requiring oxygen supplementation
Alzheimer's disease
Parkinson's disease
Any Biomedical implants with ferromagnetic content
Neurostimulation devices, cardiac pacemakers or any magnetic resonance contraindications
Traumatic brain injury with self-reported or observed loss of consciousness > 30 minutes
Any primary or traumatically induced seizure disorder
Lack of fluency in English, Wechsler Adult Reading Test below the 7th percentile (i.e., moderate or greater impairment in estimated general intelligence),
Females who are pregnant or actively attempting pregnancy (conservative exclusion for magnetic resonance research),
Current use of any medication or substance that is documented to lower seizure threshold or has been identified as a contraindication for TMS treatment.

Sites / Locations

Palo Alto VA Health Care System
Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active iTBS

Sham iTBS

Arm Description

Participants will be randomized to active or sham iTBS.

Outcomes

Primary Outcome Measures

Number of Participants Who Were Abstinent Through Month 6

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

Secondary Outcome Measures

Left Dorsolateral Prefrontal Region Glutamate/Creatine Ratio

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.

Left Dorsolateral Prefrontal Cortex Thickness

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.

General Depressive Symptoms

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

Anhedonic Depressive Symptoms

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).

Full Information

NCT ID

NCT03291431

First Posted

September 19, 2017

Last Updated

October 2, 2023

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03291431

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Terminated

Why Stopped

Recruitment difficulties due to Covid-19 pandemic

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

January 30, 2022 (Actual)

Study Completion Date

July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of intermittent theta burst repetitive transcranial magnetic stimulation (iTBS) as a treatment for Veterans with an alcohol use disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition. iTBS has demonstrated equivalent efficacy and safety to repetitive transcranial magnetic stimulation employing 10Hz stimulation protocols in treatment of depressive disorders. The advantage of iTBS is that it can be delivered in approximately 5 minutes where conventional 10Hz repetitive transcranial magnetic stimulation (rTMS) protocols are typically 20-25 minutes. It is hypothesized that Veterans with AUD who receive active iTBS applied to the left dorsolateral prefrontal cortex (DLPFC), compared to controls (i.e., Veterans with AUD who receive sham iTBS), will show significant decreases alcohol craving, depressive symptomatology and cigarette consumptions, as well as improved neurocognition, a longer period of abstinence, and a lower overall rate of relapse over 6 months following standard psychosocial treatment for AUD at VA substance treatment clinics. In exploratory analyses, it is also predicted that magnetic resonance measures of left DLPFC glutamate concentration, volume of anterior frontal cortical brain regions, and performance on fMRI tasks interrogating the function of the salience/reward circuits will serve as biomarkers of iTBS treatment response. The goal of this proposal is to implement treatment that effectively promotes sustained abstinence in Veterans with AUD, given long-term abstinence is related to optimal neurobiological, neuropsychological and psychosocial recovery and functioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder, Depressive Disorder, Cigarette Smoking

Keywords

alcohol use disorder, intermittent theta burst, Veterans, depressive disorder, cigarette smoking

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active iTBS

Arm Type

Active Comparator

Arm Description

Participants will be randomized to active or sham iTBS.

Arm Title

Sham iTBS

Arm Type

Sham Comparator

Arm Description

Participants will be randomized to active or sham iTBS.

Intervention Type

Device

Intervention Name(s)

Intermittent theta burst transcranial magnetic stimulation

Intervention Description

20 iTBS sessions (active or sham) administered over the course of 2 weeks

Primary Outcome Measure Information:

Title

Number of Participants Who Were Abstinent Through Month 6

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Left Dorsolateral Prefrontal Region Glutamate/Creatine Ratio

Description

Time Frame

baseline and follow-up (approximately 2 weeks)

Title

Left Dorsolateral Prefrontal Cortex Thickness

Description

Time Frame

baseline and follow-up (approximately 2 weeks)

Title

General Depressive Symptoms

Description

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

Time Frame

baseline and follow-up (approximately 2 weeks)

Title

Anhedonic Depressive Symptoms

Description

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).

Time Frame

baseline and follow-up (approximately 2 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 21-65 years of age Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for alcohol use disorder, and alcohol is self-identified as primary substance of misuse. Actively in treatment at VA Palo Alto HCS Addiction Treatment Service Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participation in study procedures. Exclusion Criteria: History of Schizophrenia Spectrum Disorders, Bipolar Disorders, a Current substance use disorder that exceeds the severity of the AUD (based on DSM-5 diagnostic criteria) Current use of an FDA approved medication (i.e., disulfiram, acamprosate, and naltrexone) for treatment of AUD, Active current suicidal intent or plan (patients with a previous clinical flag for risk for suicide will be required to have an established safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial), Any form of previous TMS or electroconvulsive treatment. Thyroid disease, Unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months Cerebrovascular accident Cancer if < 1 year since end of treatment Unstable diabetes COPD requiring oxygen supplementation Alzheimer's disease Parkinson's disease Any Biomedical implants with ferromagnetic content Neurostimulation devices, cardiac pacemakers or any magnetic resonance contraindications Traumatic brain injury with self-reported or observed loss of consciousness > 30 minutes Any primary or traumatically induced seizure disorder Lack of fluency in English, Wechsler Adult Reading Test below the 7th percentile (i.e., moderate or greater impairment in estimated general intelligence), Females who are pregnant or actively attempting pregnancy (conservative exclusion for magnetic resonance research), Current use of any medication or substance that is documented to lower seizure threshold or has been identified as a contraindication for TMS treatment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy C Durazzo, PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Palo Alto VA Health Care System

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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