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Brain Stimulation + Psychotherapy for Alcoholism (tACS-MI Trial)

Phase 2
Recruiting
Research Sponsored by The Mind Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-60 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month
Awards & highlights

tACS-MI Trial Summary

This trial is testing whether a brain stimulation technique called transcranial alternating current stimulation (tACS) can improve the effects of motivational interviewing (MI) for people who drink above the low-risk level. The trial will compare brain imaging, alcohol use, cannabis use, risk-taking behavior, emotions, and other measures for participants who receive MI with active stimulation, MI with sham stimulation, or no stimulation. Participants who are randomized to the delayed-treatment group will not receive brain imaging.

Who is the study for?
This trial is for right-handed individuals aged 21-60 who recognize they have a drinking problem, as indicated by their AUDIT score. They must not be currently in treatment for alcohol use disorder or have been treated in the past year, and should not have severe alcohol withdrawal history or other substance use disorders (except marijuana or nicotine).Check my eligibility
What is being tested?
The study tests if brain stimulation (tACS) can improve motivational interviewing therapy's effectiveness for people with risky drinking habits. Participants will either receive active stimulation during therapy, sham (fake) stimulation, or be placed in a delayed-treatment group without any brain stimulation.See study design
What are the potential side effects?
Potential side effects of tACS may include mild discomfort at the electrode sites on the scalp, headache, fatigue, and tingling sensations during application. The risk of serious side effects is considered low.

tACS-MI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 60 years old.

tACS-MI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heavy drinking days
Secondary outcome measures
Drinks per drinking day
Percent days abstinent

tACS-MI Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: MI with tACSExperimental Treatment2 Interventions
Motivational interviewing with concurrent active stimulation
Group II: MI-onlyActive Control1 Intervention
Motivational interviewing only, delayed treatment control
Group III: MI with shamPlacebo Group2 Interventions
Motivational interviewing with concurrent sham stimulation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motivational interviewing
2011
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

The Mind Research NetworkLead Sponsor
26 Previous Clinical Trials
2,425 Total Patients Enrolled
8 Trials studying Alcoholism
991 Patients Enrolled for Alcoholism
National Institute of General Medical Sciences (NIGMS)NIH
269 Previous Clinical Trials
247,047 Total Patients Enrolled
1 Trials studying Alcoholism
45 Patients Enrolled for Alcoholism

Media Library

Motivational interviewing Clinical Trial Eligibility Overview. Trial Name: NCT04770025 — Phase 2
Alcoholism Research Study Groups: MI with tACS, MI with sham, MI-only
Alcoholism Clinical Trial 2023: Motivational interviewing Highlights & Side Effects. Trial Name: NCT04770025 — Phase 2
Motivational interviewing 2023 Treatment Timeline for Medical Study. Trial Name: NCT04770025 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available to partake in this investigation?

"Affirmative, the information posted on clinicaltrials.gov discloses that this scientific experiment is presently searching for participants. Initial postings were made on September 1st 2020 and it was last updated in September 13th 2022. 75 individuals will be chosen from a single medical centre to take part in this trial."

Answered by AI

Would I be eligible to partake in this medical study?

"This study has accepted 75 patients, all of whom must be between 21 and 60 years old and have a history of alcohol consumption."

Answered by AI

Are senior citizens of advanced age eligible for this research experiment?

"This clinical trial has a minimum age requirement of 21 years old and an upper limit of 60."

Answered by AI

What is the cap on enrollment for this experiment?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, initially posted on September 1st 2020, is still recruiting participants. 75 volunteers must be drawn from one site for further investigation."

Answered by AI

How reliable is High-density transcranial alternating current stimulation in protecting human health?

"According to our internal assessment, high-density transcranial alternating current stimulation is moderately safe with a score of 2. This comes from the fact that Phase 2 trials have yielded data on safety but not yet efficacy."

Answered by AI

Who else is applying?

What state do they live in?
New Mexico
How old are they?
18 - 65
What site did they apply to?
The Mind Research Network
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Pilot Study of Non-invasive Brain Stimulation to Boost the Efficacy of Psychotherapy in a Community Sample of People Who Drink Alcohol
2020. "A Pilot Study of Non-invasive Brain Stimulation to Boost the Efficacy of Psychotherapy in a Community Sample of People Who Drink Alcohol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04770025.
All > Alcoholism
~12 spots leftby Dec 2024
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