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

October 2, 2023 updated by: Timothy Durazzo, PhD, Stanford University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Palo Alto VA Health Care System
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active iTBS
Participants will be randomized to active or sham iTBS.
Device: Intermittent theta burst transcranial magnetic stimulation
20 iTBS sessions (active or sham) administered over the course of 2 weeks
Sham Comparator: Sham iTBS
Participants will be randomized to active or sham iTBS.
Device: Intermittent theta burst transcranial magnetic stimulation
20 iTBS sessions (active or sham) administered over the course of 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Were Abstinent Through Month 6
Time Frame: 6 months
Number of particiants in active vs. sham who maintained completed abstinence from alcohol/substance over 6 months post final rTMS session.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Dorsolateral Prefrontal Region Glutamate/Creatine Ratio
Time Frame: baseline and follow-up (approximately 2 weeks)
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.
baseline and follow-up (approximately 2 weeks)
General Depressive Symptoms
Time Frame: baseline and follow-up (approximately 2 weeks)
Beck Depression Inventory-II score pre and post active/sham iTBS (score range, 0 to 63, higher scores indicate more severe symptoms).
baseline and follow-up (approximately 2 weeks)
Anhedonic Depressive Symptoms
Time Frame: baseline and follow-up (approximately 2 weeks)
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).
baseline and follow-up (approximately 2 weeks)
Left Dorsolateral Prefrontal Cortex Thickness
Time Frame: baseline and follow-up (approximately 2 weeks)
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.
baseline and follow-up (approximately 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Timothy C Durazzo, PhD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41896

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depressive Disorder

Clinical Trials on Intermittent theta burst transcranial magnetic stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe