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NCT Number: NCT04770025

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

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol Drinking Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

Location status: Recruiting

Location contact

Jon M Houck, PhD

CONTACT

[email protected]

505-925-2372

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-density transcranial alternating current stimulation

Device

High-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range

Sham stimulation

Device

High-density electrode configuration with sham stimulation

Motivational Interviewing

Behavioral

Motivational interviewing session focused on alcohol use, approximately 30 minutes in length

Primary outcomes

  1. Heavy drinking days

    Time frame: One month

    Number of heavy drinking days in the prior 30 days

Secondary outcomes

  1. Drinks per drinking day

    Time frame: One month

    Number of drinks per drink day in the prior 30 days

  2. Percent days abstinent

    Time frame: One month

    Percent days abstinent in the prior 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Jon M Houck, PhD

CONTACT

[email protected]

(505) 925-2372

Sponsors and collaborators

Lead sponsor

The Mind Research Network

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Transcranial Alternating Current Stimulation to Boost the Efficacy of Motivational Interviewing

Acronym: tACS-MI

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Feb 25, 2021
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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