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Behavioural Intervention

Theta Burst Stimulation for Alcohol Use Disorder

N/A

Recruiting

Led By Gopalkumar Rakesh, PhD

Research Sponsored by Gopalkumar Rakesh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

21-60 years of age

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after two ctbs sessions, approximately 2 hours

Awards & highlights

Study Summary

This trial will study how a brain stimulation technique affects alcohol craving in people with AUD.

Who is the study for?

This trial is for adults aged 21-60 with moderate alcohol use disorder who are patients at the University of Kentucky Healthcare. Participants must understand English and follow hospital rules. It's not for pregnant women, those without an initial attention to alcohol cues, or individuals with brain injury, seizure disorders, schizophrenia, metal in their head, previous bad reactions to TMS or inconsistent task performance.Check my eligibility

What is being tested?

The study tests two sessions of continuous theta burst stimulation (cTBS) on the same day and measures changes in brain activity via fMRI scans, attentional bias towards alcohol-related cues and cravings for alcohol in people with AUD.See study design

What are the potential side effects?

While specific side effects aren't listed here, cTBS can sometimes cause discomfort at the stimulation site on the scalp, headache or lightheadedness immediately after treatment.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after two ctbs sessions, approximately 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after two ctbs sessions, approximately 2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after two ctbs sessions, approximately 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Alcohol cue attentional bias

Change in Penn Alcohol Craving Scale

Secondary outcome measures

Resting state functional connectivity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Active cTBS and sham cTBSExperimental Treatment2 Interventions

There is only one arm in this study and all participants in this arm will receive 2 interventions: active and sham cTBS in a within subject blinded fashion. They will first receive active cTBS and then sham cTBS, separated by four weeks to minimize carryover effects.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sham cTBS

2016

Completed Phase 2

~220

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,411 Total Patients Enrolled

5 Trials studying Alcoholism

35,479 Patients Enrolled for Alcoholism

Gopalkumar RakeshLead Sponsor

3 Previous Clinical Trials

109 Total Patients Enrolled

Gopalkumar Rakesh, PhDPrincipal InvestigatorUniversity of Kentucky

Frequently Asked Questions

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

What are the criteria for participating in this clinical trial?

"Eligibility for this trial requires any applicant to have an alcohol use disorder and be between 21-60 years old. Currently, there are 30 open spots available."

Answered by AI

Is there any availability for participants in this trial?

"Clinicaltrials.gov states that this investigation is presently recruiting patients, with the initial post dating back to September 30th 2023 and latest update being on September 22nd of the same year."

Answered by AI

Is the age limit for participants in this trial restricted to persons under 30?

"Patients must meet the age requisites of 21 to 60 in order to be included in this trial. There exist 33 clinical trials for those under 18 and 266 studies tailored towards individuals aged 65 or more."

Answered by AI

What is the capacity of participants for this experiment?

"Affirmative. According to clinicaltrials.gov, this trial is actively enlisting participants and was initially posted on September 30th 2023. The last modification occured on the 22nd of September 2023 with a goal of recruiting thirty subjects from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Theta Burst Stimulation for Alcohol Use Disorder

Gopalkumar Rakesh 2023. "Theta Burst Stimulation for Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06060496.