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
Transcranial Alternating Current Stimulation to Boost the Efficacy of Motivational Interviewing
2 other identifiers
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2020
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedMay 8, 2025
May 1, 2025
5.3 years
February 22, 2021
May 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heavy drinking days
Number of heavy drinking days in the prior 30 days
One month
Secondary Outcomes (2)
Drinks per drinking day
One month
Percent days abstinent
One month
Study Arms (3)
MI with tACS
EXPERIMENTALMotivational interviewing with concurrent active stimulation
MI with sham
SHAM COMPARATORMotivational interviewing with concurrent sham stimulation
MI-only
ACTIVE COMPARATORMotivational interviewing only, delayed treatment control
Interventions
High-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range
Motivational interviewing session focused on alcohol use, approximately 30 minutes in length
Eligibility Criteria
You may qualify if:
- Self-identify as having problem drinking
- Right-handed
- Age 21-60 years
- AUDIT score indicating risky drinking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Mind Research Network
Albuquerque, New Mexico, 87106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Double (Participant, Providers/Research Assistants)
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2021
First Posted
February 25, 2021
Study Start
September 1, 2020
Primary Completion
December 31, 2025
Study Completion
February 28, 2026
Last Updated
May 8, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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)
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.