Recruiting
Phase 2

Non-invasive Brain Stimulation

Sponsor:

The Mind Research Network

Code:

NCT04770025

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

Interventions

High-density transcranial alternating current stimulation

Sham stimulation

Motivational interviewing

Study Details

Brief summary:

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.

Conditions

Alcohol Use Disorder

Study ID

NCT04770025

Start date

Sep 1, 2020

Status verified date

May, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: MI with tACS

Motivational interviewing with concurrent active stimulation

sham comparator: MI with sham

Motivational interviewing with concurrent sham stimulation

active comparator: MI-only

Motivational interviewing only, delayed treatment control

Interventions

High-density transcranial alternating current stimulation

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

Sham stimulation

High-density electrode configuration with sham stimulation

Motivational interviewing

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

Primary outcome measure

  • Heavy drinking days [ Time Frame: One month ]

Central Contacts and Locations

Central contacts

Locations

The Mind Research Network

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

More Information

Sponsor

The Mind Research Network

Last update posted

May 8, 2025

Last verified

May, 2025

Keywords

  • Alcohol Use Disorder
  • Motivational Interviewing
  • Transcranial Electrical Stimulation
  • Alcohol Drinking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Mind Research Network on 2025-05-08.