Alcohol Use DisorderPhase 2tACS-MINCT04770025
A Pilot Study of Non-invasive Brain Stimulation to Boost the Efficacy of Psychotherapy in a Community Sample of People Who Drink Alcohol
A Phase 2 study testing High-density transcranial alternating current stimulation and Motivational interviewing in people with Alcohol Use Disorder, run by The Mind Research Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- High-density transcranial alternating current stimulation and Motivational interviewing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identify as having problem drinking
- Right-handed
- Age 21-60 years
- AUDIT score indicating risky drinking
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Mind Research Network
Albuquerque, New Mexico, 87106
Jon M Houck, PhD, 505-925-2372, brainstim@mrn.org
About this study
Official title: Transcranial Alternating Current Stimulation to Boost the Efficacy of Motivational Interviewing
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- High-density transcranial alternating current stimulation, Sham stimulation, Motivational interviewing
- Keywords
- Alcohol Use Disorder, Motivational Interviewing, Transcranial Electrical Stimulation, Alcohol Drinking
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-density transcranial alternating current stimulationDevice
High-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range
Sham stimulationDevice
High-density electrode configuration with sham stimulation
Motivational interviewingBehavioural
Motivational interviewing session focused on alcohol use, approximately 30 minutes in length
| Study group | Role | What they receive |
|---|---|---|
| MI with tACS | Experimental | Motivational interviewing with concurrent active stimulation Receives: Device: High-density transcranial alternating current stimulation; Behavioral: Motivational interviewing |
| MI with sham | Sham comparator | Motivational interviewing with concurrent sham stimulation Receives: Device: Sham stimulation; Behavioral: Motivational interviewing |
| MI-only | Active comparator | Motivational interviewing only, delayed treatment control Receives: Behavioral: Motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heavy drinking days
Number of heavy drinking days in the prior 30 days
Measured: One month
Secondary outcomes (2)
Drinks per drinking day
Number of drinks per drink day in the prior 30 days
Measured: One month
Percent days abstinent
Percent days abstinent in the prior 30 days
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Sep 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind proof-of-concept randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Mind Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770025
- Sponsor's protocol ID
- 20-010
- Other IDs
- P30GM122734
- Acronym
- tACS-MI
- Status last verified
- May 2025
- First submitted
- 22 Feb 2021
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Alternating Current Stimulation to Boost the Efficacy of Motivational Interviewing
- ClinicalTrials.gov ID
- NCT04770025
- Acronym / sponsor ID
- tACS-MI / 20-010
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol Use Disorder, Motivational Interviewing, Transcranial Electrical Stimulation, Alcohol Drinking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The Mind Research NetworkUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Double-blind proof-of-concept randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| MI with tACS | Experimental | Device: High-density transcranial alternating current stimulation, Behavioral: Motivational interviewingMotivational interviewing with concurrent active stimulation |
| MI with sham | Sham comparator | Device: Sham stimulation, Behavioral: Motivational interviewingMotivational interviewing with concurrent sham stimulation |
| MI-only | Active comparator | Behavioral: Motivational interviewingMotivational interviewing only, delayed treatment control |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Self-identify as having problem drinking
- Right-handed
- Age 21-60 years
- AUDIT score indicating risky drinking
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-density transcranial alternating current stimulationHigh-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range | Device | MI with tACS |
| Sham stimulationHigh-density electrode configuration with sham stimulation | Device | MI with sham |
| Motivational interviewingMotivational interviewing session focused on alcohol use, approximately 30 minutes in length | Behavioural | MI with sham, MI with tACS, MI-only |
Primary outcome
Heavy drinking days
Time frame: One month
Number of heavy drinking days in the prior 30 days
2 secondary outcomes
Drinks per drinking day
Time frame: One month
Percent days abstinent
Time frame: One month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High-density transcranial alternating current stimulation and Motivational interviewing in people with Alcohol Use Disorder, run by The Mind Research Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jon M Houck, PhD ((505) 925-2372, brainstim@mrn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heavy drinking days (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.