Skip to main content
Clinical Trials/NCT04770025
NCT04770025
Recruiting
Phase 2

Transcranial Alternating Current Stimulation to Boost the Efficacy of Motivational Interviewing

The Mind Research Network1 site in 1 country75 target enrollmentSeptember 1, 2020

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Alcohol Use Disorder
Sponsor
The Mind Research Network
Enrollment
75
Locations
1
Primary Endpoint
Heavy drinking days
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
February 28, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Heavy drinking days

Time Frame: One month

Number of heavy drinking days in the prior 30 days

Secondary Outcomes

  • Drinks per drinking day(One month)
  • Percent days abstinent(One month)

Study Sites (1)

Loading locations...

Similar Trials