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

NCT ID: NCT04770025

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind proof-of-concept randomized clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers
Double (Participant, Providers/Research Assistants)

Study Groups

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MI with tACS

Motivational interviewing with concurrent active stimulation

Group Type EXPERIMENTAL

High-density transcranial alternating current stimulation

Intervention Type DEVICE

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

Motivational interviewing

Intervention Type BEHAVIORAL

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

MI with sham

Motivational interviewing with concurrent sham stimulation

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

High-density electrode configuration with sham stimulation

Motivational interviewing

Intervention Type BEHAVIORAL

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

MI-only

Motivational interviewing only, delayed treatment control

Group Type ACTIVE_COMPARATOR

Motivational interviewing

Intervention Type BEHAVIORAL

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

Interventions

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High-density transcranial alternating current stimulation

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

Intervention Type DEVICE

Sham stimulation

High-density electrode configuration with sham stimulation

Intervention Type DEVICE

Motivational interviewing

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

The Mind Research Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Mind Research Network

Albuquerque, New Mexico, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jon M Houck, PhD

Role: CONTACT

(505) 925-2372

Facility Contacts

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Jon M Houck, PhD

Role: primary

505-925-2372

Provided Documents

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Document Type: Informed Consent Form: Informed Consent

View Document

Document Type: Informed Consent Form: Informed Consent - Phase I online-only

View Document

Other Identifiers

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P30GM122734

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-010

Identifier Type: -

Identifier Source: org_study_id

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