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

Phase 2

Recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Device: High-density transcranial alternating current stimulation; Device: Sham stimulation; Behavioral: Motivational interviewing

• Registration Number: NCT04770025
• Lead Sponsor: The Mind Research Network

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.

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 Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MI with tACS	High-density transcranial alternating current stimulation	Motivational interviewing with concurrent active stimulation
MI with sham	Sham stimulation	Motivational interviewing with concurrent sham stimulation
MI-only	Motivational interviewing	Motivational interviewing only, delayed treatment control
MI with tACS	Motivational interviewing	Motivational interviewing with concurrent active stimulation
MI with sham	Motivational interviewing	Motivational interviewing with concurrent sham stimulation

Primary Outcome Measures

Name	Time	Method
Heavy drinking days	One month	Number of heavy drinking days in the prior 30 days

Secondary Outcome Measures

Name	Time	Method
Drinks per drinking day	One month	Number of drinks per drink day in the prior 30 days
Percent days abstinent	One month	Percent days abstinent in the prior 30 days

Trial Locations

Locations (1)

The Mind Research Network; 🇺🇸 Albuquerque, New Mexico, United States