NCT04154111

Brief Summary

There is growing interest in the utilization of transcranial magnetic stimulation (TMS) as a novel, non-pharmacologic approach to decreasing alcohol use among treatment-seeking individuals with Alcohol Use Disorder (AUD). The results of this study will be used to determine which of the 2 proposed TMS strategies has a larger effect on drinking behavior (% days abstinent, % heavy drinking days) as well as alcohol cue-reactivity in a 4 month period. These data will pave the way for TMS to be used as an innovative, new treatment option for individuals with AUD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

May 26, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

November 4, 2019

Last Update Submit

March 26, 2026

Conditions

Alcohol Use DisorderAlcohol AbuseAlcohol DependenceCraving

Keywords

Transcranial Magnetic StimulationBrain StimulationTreatmentNeuroimaging

Outcome Measures

Primary Outcomes (2)

  • Percent days abstinent

    These outcomes will be measured with urine ETG and CDT drug screens collected monthly up to 4 months.

    Through study completion, up to 4 month follow-up

  • Percentage of heavy drinking days

    The percentage of heavy drinking days will be measured by timeline follow-back. Individuals will be asked to track their daily alcohol consumption over the course of the study.

    Through study completion, up to 4 month follow-up

Secondary Outcomes (2)

  • Changes in Craving

    Baseline visit, 1-4 month follow-ups

  • Neuroimaging outcomes: change in drug cue reactivity as specified by changes in BOLD signal

    Baseline visit and 1 month follow-up

Study Arms (4)

Real TBS to the mPFC

EXPERIMENTAL

Thirty sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC)

Device: Real TBS to the vmPFC

Sham TBS to the mPFC

SHAM COMPARATOR

Thirty sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC)

Device: Sham TBS to the vmPFC

Real TBS to the dlPFC

EXPERIMENTAL

Thirty sessions of real Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC)

Device: Real TBS to the dlPFC

Sham TBS to the dlPFC

SHAM COMPARATOR

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

Device: Sham TBS to the dlPFC

Interventions

Real TBS to the vmPFCDEVICE

This will be delivered with the Magventure Magpro system; double blinded

Real TBS to the mPFC
Sham TBS to the vmPFCDEVICE

The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.

Sham TBS to the mPFC
Real TBS to the dlPFCDEVICE

This will be delivered with the Magventure Magpro system (double blinded).

Real TBS to the dlPFC
Sham TBS to the dlPFCDEVICE

The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.

Sham TBS to the dlPFC

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21- 75.
  • Meets the DSM V criteria for having a current AUD, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V.
  • Has an AUDIT score above 8 (such that they are at least Medium Risk drinkers according to criteria).

You may not qualify if:

  • Any psychoactive substance use (except marijuana and nicotine) within the last 30 days by self-report.
  • Has current suicidal ideation or homicidal ideation.
  • Expects a change in their medical history in the next 6 months that would impair their participation in this study \[e.g. expected medical procedure, planned pregnancy, initiation of new medication\].
  • 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.
  • Suffers from chronic migraines (more than 50% of the days in a month).
  • Does not meet safety criteria for MRI and TMS
  • Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold and has had a change in their medication).
  • Is currently enrolled in another form of treatment for alcohol use disorder (This is for scientific reasons to clarify the role of TMS as a treatment agent)
  • 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.
  • Not able to read and understand questionnaires, assessments, and the informed consent.
  • Clinical Intake Withdrawal Assessment (CIWA) \>5 (to prevent delivering TMS to individuals in withdrawal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • Kinney KR, Kirse HA, Stewart NE, Ip EH, Saldana S, DeMaioNewton HE, Kimber M, Smith HR, Douglas HE, Kiraly DD, Hanlon CA, Addicott MA. Theta Burst Stimulation as a tool to decrease drinking in treatment-seeking alcohol users: study protocol for a randomized, double-blind, sham-controlled clinical trial. Trials. 2025 Nov 10;26(1):487. doi: 10.1186/s13063-025-09093-1.

    PMID: 41214823DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Merideth A Addicott, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 6, 2019

Study Start

May 26, 2020

Primary Completion

February 9, 2026

Study Completion

February 9, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Deidentified participant data will be shared with the NIAAA data Archive. Data to be shared will be treatment arm, demographics, substance use assessment results, and imaging data.

Time Frame
Data will be shared following the processing and analyses of imaging data, up to 6 months after publication.
Access Criteria
Access to the deidentified data will only be through the NIAAA Data Repository, who define the criteria for access.

Locations

US(1)