A Pilot Study of Non-invasive Brain Stimulation to Boost the Efficacy of Psychotherapy in a Community Sample of People Who Drink Alcohol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-density transcranial alternating current stimulation, Sham stimulation, Motivational interviewing.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder. Basic parameters: 21 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transcranial Alternating Current Stimulation to Boost the Efficacy of Motivational Interviewing
Overview
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.
Interventions
- Device High-density transcranial alternating current stimulation
High-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range - 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
Primary outcome measures
- Heavy drinking days [Time frame: One month]
Secondary outcome measures (2)
- Drinks per drinking day [Time frame: One month]
- Percent days abstinent [Time frame: One month]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- The Mind Research Network — Albuquerque
Identifiers
NCT: NCT04770025 · 20-010 · P30GM122734