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

NCT ID: NCT03291431

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2022-07-30

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.

Conditions

Alcohol Use Disorder; Depressive Disorder; Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active iTBS

Participants will be randomized to active or sham iTBS.

Group Type: ACTIVE_COMPARATOR

Intermittent theta burst transcranial magnetic stimulation

Intervention Type: DEVICE

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

Sham iTBS

Participants will be randomized to active or sham iTBS.

Group Type: SHAM_COMPARATOR

Intermittent theta burst transcranial magnetic stimulation

Intervention Type: DEVICE

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

Interventions

Intermittent theta burst transcranial magnetic stimulation

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Timothy Durazzo, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy C Durazzo, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Palo Alto VA Health Care System

Palo Alto, California, United States

Stanford University

Stanford, California, United States

Countries

United States

References

Durazzo TC, McNerney MW, Hansen AM, Gu M, Sacchet MD, Padula CB. BDNF rs6265 Met carriers with alcohol use disorder show greater age-related decline of N-acetylaspartate in left dorsolateral prefrontal cortex. Drug Alcohol Depend. 2023 Jul 1;248:109901. doi: 10.1016/j.drugalcdep.2023.109901. Epub 2023 Apr 28.

Reference Type: DERIVED

PMID: 37146499 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

41896

Identifier Type: -

Identifier Source: org_study_id