Alcohol Use Disorder
Conditions
Keywords
Alcohol Use Disorder, Motivational Interviewing, Transcranial Electrical Stimulation, Alcohol Drinking
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.
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
DEVICEHigh-density transcranial alternating current stimulation
High-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range
DEVICESham stimulation
High-density electrode configuration with sham stimulation
BEHAVIORALMotivational interviewing
Motivational interviewing session focused on alcohol use, approximately 30 minutes in length
Sponsors
National Institute of General Medical Sciences (NIGMS)
The Mind Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double (Participant, Providers/Research Assistants)
Intervention model description
Double-blind proof-of-concept randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heavy drinking days | One month | Number of heavy drinking days in the prior 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drinks per drinking day | One month | Number of drinks per drink day in the prior 30 days |
| Percent days abstinent | One month | Percent days abstinent in the prior 30 days |
Countries
United States
Contacts
Primary ContactJon M Houck, PhD
Outcome results
None listed