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

Study Overview
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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.

Official Title
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Transcranial Alternating Current Stimulation to Boost the Efficacy of Motivational Interviewing

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Device: High-density transcranial alternating current stimulation
* Device: Sham stimulation
* Behavioral: Motivational interviewing


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind proof-of-concept randomized clinical trial
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Drinking, Alcohol Use Disorder, Motivational Interviewing, Transcranial Electrical Stimulation