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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 belowSelect...
I am between 21 and 60 years old.
tACS-MI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month
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
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Who is running the clinical trial?
The Mind Research NetworkLead Sponsor
26 Previous Clinical Trials
2,395 Total Patients Enrolled
8 Trials studying Alcoholism
961 Patients Enrolled for Alcoholism
National Institute of General Medical Sciences (NIGMS)NIH
272 Previous Clinical Trials
246,948 Total Patients Enrolled
1 Trials studying Alcoholism
45 Patients Enrolled for Alcoholism
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot use American Sign Language for psychotherapy due to my hearing impairment.You cannot have an MRI or transcranial alternating current stimulation (tACS) if you are pregnant.I am unable to understand and give consent for treatment.You are currently receiving treatment for alcohol addiction.You have received treatment for alcohol addiction in the last 12 months.Within the past year, you have had a problem with drugs other than alcohol, marijuana or nicotine.You are right-handed.You have experienced severe alcohol withdrawal in the past or are currently experiencing it.You consider yourself to have a drinking problem.You are left-handed or can use both of your hands equally well.I am between 21 and 60 years old.I am currently experiencing psychosis.I have had a brain injury or been diagnosed with a neurological condition.
Research Study Groups:
This trial has the following groups:- Group 1: MI with tACS
- Group 2: MI with sham
- Group 3: MI-only
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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