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

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ClinicalTrials.gov Identifier: NCT03291431
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy Durazzo, Stanford University

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Depressive Disorder Cigarette Smoking Device: Intermittent theta burst transcranial magnetic stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intermittent Theta Burst TMS for the Treatment of Alcohol Use Disorders in Veterans
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: Active iTBS Device: 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 Comparator: Sham iTBS Device: 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




Primary Outcome Measures :
  1. Duration of abstinence [ Time Frame: 6 months ]
    Duration of abstinence after final iTBS session


Secondary Outcome Measures :
  1. Left dorsolateral prefrontal region glutamate [ Time Frame: 2 weeks ]
    Left dorsolateral prefrontal region glutamate concentration pre and post active/sham iTBS

  2. Left dorsolateral prefrontal cortex thickness [ Time Frame: 2 weeks ]
    Left dorsolateral prefrontal cortex thickness pre and post active/sham iTBS

  3. Depressive symptoms [ Time Frame: 2 weeks ]
    Beck Depression Inventory-II score pre and post active/sham iTBS

  4. Cigarette consumption [ Time Frame: 2 weeks ]
    Cigarettes smoked/day pre and post active/sham iTBS



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291431


Contacts
Contact: Timothy C Durazzo, PhD 650-493-5000 ext 62982 tdurazzo@stanford.edu
Contact: Claudia B Padulla, PhD padula@stanford.edu

Locations
United States, California
Palo Alto VA Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Timothy C Durazzo, PhD    650-493-5000 ext 62982    tdurazzo@stanford.edu   
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Timothy C Durazzo, PhD       tdurazzo@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Timothy C Durazzo, PhD Stanford University

Responsible Party: Timothy Durazzo, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03291431     History of Changes
Other Study ID Numbers: 41896
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Timothy Durazzo, Stanford University:
alcohol use disorder
intermittent theta burst
Veterans
depressive disorder
cigarette smoking

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Alcohol Drinking
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs