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

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ClinicalTrials.gov Identifier: NCT04770025
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Device: High-density transcranial alternating current stimulation Device: Sham stimulation Behavioral: Motivational interviewing Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind proof-of-concept randomized clinical trial
Masking: Double (Participant, Care Provider)
Masking Description: Double (Participant, Providers/Research Assistants)
Primary Purpose: Other
Official Title: Transcranial Alternating Current Stimulation to Boost the Efficacy of Motivational Interviewing
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: MI with tACS
Motivational interviewing with concurrent active stimulation
Device: High-density transcranial alternating current stimulation
High-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range

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

Sham Comparator: MI with sham
Motivational interviewing with concurrent sham stimulation
Device: Sham stimulation
High-density electrode configuration with sham stimulation

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

Active Comparator: MI-only
Motivational interviewing only, delayed treatment control
Behavioral: Motivational interviewing
Motivational interviewing session focused on alcohol use, approximately 30 minutes in length




Primary Outcome Measures :
  1. Heavy drinking days [ Time Frame: One month ]
    Number of heavy drinking days in the prior 30 days


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770025


Contacts
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Contact: Jon M Houck, PhD (505) 925-2372 brainstim@mrn.org

Locations
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United States, New Mexico
The Mind Research Network Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Jon M Houck, PhD    505-925-2372    brainstim@mrn.org   
Sponsors and Collaborators
The Mind Research Network
National Institute of General Medical Sciences (NIGMS)
  Study Documents (Full-Text)

Documents provided by The Mind Research Network:
Informed Consent Form: Informed Consent  [PDF] September 20, 2020

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Responsible Party: The Mind Research Network
ClinicalTrials.gov Identifier: NCT04770025    
Other Study ID Numbers: 20-010
P30GM122734 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results reported in a peer-reviewed publication, after deidentification (text, tables, figures, and appendices). Session audio recordings will not be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal will have access to the data. A data use agreement will be required, signed by the requesting investigator and their Authorized Organization Representative (AOR)/Signing Official (SO)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The Mind Research Network:
Alcohol Use Disorder
Motivational Interviewing
Transcranial Electrical Stimulation
Alcohol Drinking
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders