Effect of Theta Burst Stimulation on Alcohol Cue Reactivity

NCT04223154 | Completed Results DMC FDA Device

• 1 other identifier: IRB00063018
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Alcohol Use Disorder (AUD) is prevalent, devastating, and difficult to treat. The intransigence of AUD is readily apparent in the Trauma Unit of Wake Forest University Baptist Hospital, wherein 23% of trauma related admissions are associated with alcohol - higher than the national average of 16%. Of these trauma related admissions, over 70% are estimated to have AUD and 41% will be likely be admitted to the trauma unit again within 5 years. While Dr. Veach (Co-Investigator) and her team in the Department of Surgery have demonstrated that a brief counseling intervention on the inpatient trauma unit can decrease morbidity and recidivism, the rates of AUD and relapse to drinking among these individuals remains very high. With a growing knowledge of the neural circuits that contribute to relapse in AUD, there is an emerging interest in developing a novel, neural-circuit specific therapeutic tool to enhance AUD treatment outcomes. This will be achieved through a double-blind, sham-controlled cohort study in heavy alcohol drinkers with a history of alcohol-related injury. The brain reactivity to alcohol cues (Incentive Salience) and cognitive performance in the presence of an alcoholic beverage cue (Cognitive Control) will be measured immediately before and after participants receive real or sham intermittent theta burst stimulation (iTBS- a potentiating form of transcranial magnetic stimulation (TMS)) to the dorsolateral prefrontal cortex (dlPFC iTBS). The goals of this pilot study are to quantify the acute effect of a single session of real or sham dlPFC iTBS on brain response to alcohol cues (Aim 1) and cognitive flexibility in the presence of an alcohol cue (Aim 2) among risky drinkers (target engagement ).

Conditions

Alcohol Drinking; Alcohol Use Disorder; Trauma Injury; Alcohol Dependence; Alcohol Abuse

Keywords

Transcranial Magnetic Stimulation; Brain Stimulation; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Behavioral Outcomes: Change in the k-Value, a Measure of Delay Discounting of Alcohol

  This outcome measure rates the change in k-value, or the delay discounting value of alcohol compared at baseline vs 1 hour after the intervention. Delay discounting is the tendency to place less value on rewards that are delayed in time. K typically falls between 0.0 and 0.5, with smaller values indicating a lack of discounting and a preference for delayed rewards, and higher values indicating stronger discounting and a preference for immediate rewards.

  Baseline to 1 hour after the intervention

Study Arms (2)

Real TBS to the dlPFC

EXPERIMENTAL

One session of real intermittent Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC)

Device: Real iTBS to the dlPFC

Sham TBS to the dlPFC

SHAM COMPARATOR

One session of sham Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC)

Device: Sham iTBS to the dlPFC

Interventions

Real iTBS to the dlPFC DEVICE

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).

Real TBS to the dlPFC

Sham iTBS to the dlPFC DEVICE

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).

Sham TBS to the dlPFC

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 21-65.
• Alcohol use disorder identification test score \>7
• Drink at least 20 standard sized alcohol beverage servings per week

You may not qualify if:

• Current use of prescription or illicit psychoactive drugs (except marijuana or nicotine) known to decrease seizure threshold by self-report in the last 30 days.
• Currently meets DSM-V criteria for substance use disorder for a substance other than alcohol, marijuana, or nicotine.
• Has current suicidal or homicidal ideation.
• Current breath alcohol concentration \>0.002
• Not currently at risk for withdrawal, as indicated by CIWA-Ar \>5.
• History of seizures or seizure disorder(s).
• Females of childbearing potential who are pregnant (by urine HCG), planning to become pregnant, nursing, or who are not using a reliable form of birth control.
• Any other violation of MRI/TMS safety measures.
• Unable to read and understand questionnaires, assessments, and the informed consent.
• No presence of metal objects in the head/neck.
• History of traumatic brain injury resulting in hospitalization, loss of consciousness for more than 10 minutes, and/or having ever been informed he/she has an epidural, subdural, or subarachnoid hemorrhage.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism; Accidental Injuries

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Wounds and Injuries

Results Point of Contact

• Title: Colleen A. Hanlon, Ph.D.
• Organization: Wake Forest University School of medicine

chanlon@wakehealth.edu

336-716-5465

Study Officials

• Colleen Hanlon, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: August 26, 2020
• Primary Completion: April 16, 2021
• Study Completion: April 16, 2021
• Last Updated: May 19, 2023
• Results First Posted: November 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)