A Pilot Study of Non-invasive Brain Stimulation to Boost the Efficacy of Psychotherapy in a Community Sample of People Who Drink Alcohol (tACS-MI)

May 6, 2025 updated by: The Mind Research Network

Transcranial Alternating Current Stimulation to Boost the Efficacy of Motivational Interviewing

The goal of this small (n=75) proof-of-concept randomized clinical trial is to test the effects of transcranial alternating current stimulation (tACS) during motivational interviewing (MI) sessions with participants who drink at above the low-risk level. Participants will be randomized to receive either MI with active stimulation, MI with sham stimulation, or a delayed treatment group that receives MI with no stimulation. Measures will include brain imaging, alcohol use, cannabis use, risk-taking behavior, emotions, and others. Participants who are randomized to the delayed-treatment group will not receive brain imaging.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This proof-of-concept randomized clinical trial will recruit n=75 people with problematic levels of drinking who are considering treatment for their alcohol use. These participants will be randomized to one of three conditions: a condition that applies active tACS during an MI session (MI+tACS), a condition that applies sham stimulation during an MI session (MI+sham), or a waitlist control condition (MI-only). Only participants the MI+tACS and MI+sham conditions will be included in the brain imaging portion of the study. One month after their intervention session, all participants will report their use of alcohol in the prior 30 days via an online assessment battery. This will allow us to test the effects of tACS on within-session client speech and outcomes.

Participants will have magnetoencephalography (MEG) scans including rest and an alcohol cue task to measure the acute effects of brain stimulation. Participants will also have MRI scans including structure and rest. The Motivational Interviewing Skill Code (MISC 2.5) and the CASAA Application for Coding Treatment Interactions (CACTI) will be used to assess counselor and participant speech in the recorded MI sessions and to ensure that sessions comply with the principles of MI.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • The Mind Research Network
        • Contact:

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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Self-identify as having problem drinking
  • Right-handed
  • Age 21-60 years
  • AUDIT score indicating risky drinking

Exclusion criteria:

  • Left-handed or ambidextrous
  • Currently engaged in treatment for alcohol use disorder
  • Receiving treatment for alcohol use disorder within the prior 12 months
  • History of brain injury or neurological diagnosis
  • Evidence of current psychosis
  • Past-year substance use disorder other than alcohol, marijuana, or nicotine
  • Current or history of severe alcohol withdrawal
  • MRI/tACS contraindications including pregnancy
  • Impaired hearing (psychotherapy using American Sign Language is not possible within the scope of the proposed study)
  • Insufficient corrected visual acuity to complete the assessment instruments
  • Unable to read/speak English fluently
  • Unable to provide valid informed consent

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MI with tACS
Motivational interviewing with concurrent active stimulation
Device: High-density transcranial alternating current stimulation
High-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range
Behavioral: Motivational interviewing
Motivational interviewing session focused on alcohol use, approximately 30 minutes in length
Sham Comparator: MI with sham
Motivational interviewing with concurrent sham stimulation
Behavioral: Motivational interviewing
Motivational interviewing session focused on alcohol use, approximately 30 minutes in length
Device: Sham stimulation
High-density electrode configuration with sham stimulation
Active Comparator: MI-only
Motivational interviewing only, delayed treatment control
Behavioral: Motivational interviewing
Motivational interviewing session focused on alcohol use, approximately 30 minutes in length

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heavy drinking days
Time Frame: One month
Number of heavy drinking days in the prior 30 days
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinks per drinking day
Time Frame: One month
Number of drinks per drink day in the prior 30 days
One month
Percent days abstinent
Time Frame: One month
Percent days abstinent in the prior 30 days
One month

Collaborators and Investigators

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

Sponsor

The Mind Research Network

Collaborators

National Institute of General Medical Sciences (NIGMS)

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)

September 1, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-010
  • P30GM122734 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie results reported in a peer-reviewed publication, after deidentification (text, tables, figures, and appendices). Session audio recordings will not be shared.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal will have access to the data. A data use agreement will be required, signed by the requesting investigator and their Authorized Organization Representative (AOR)/Signing Official (SO)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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.

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