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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
Must not have
History of brain injury or neurological diagnosis
Impaired hearing (psychotherapy using American Sign Language is not possible within the scope of the proposed study)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month

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).
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a brain injury or been diagnosed with a neurological condition.
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I cannot use American Sign Language for psychotherapy due to my hearing impairment.
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I am unable to understand and give consent for treatment.
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I am currently experiencing psychosis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Heavy drinking days
Secondary study objectives
Drinks per drinking day
Percent days abstinent

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
2,267 Total Patients Enrolled
8 Trials studying Alcoholism
961 Patients Enrolled for Alcoholism
National Institute of General Medical Sciences (NIGMS)NIH
291 Previous Clinical Trials
248,701 Total Patients Enrolled
1 Trials studying Alcoholism
37 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
~1 spots leftby Dec 2024
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