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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be between the ages of 18 and 40
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after the first primary outcome.
Awards & highlights
Study Summary
This trial will use new non-invasive neurostimulation technology to treat adults with opioid use disorders, with the goal of identifying brain regions that could be targeted in future clinical trials.
Who is the study for?
Adults aged 18-40 who smoke at least three-quarters of a pack of cigarettes daily, can speak and read English, have at least a 6th-grade education, and own a phone with internet. Excluded are those with cranial abnormalities or metal implants, IUD users without safety documentation for MRI, pregnant individuals, those over 440 lbs., pacemaker users, people on certain medications including psychotropics or with cognitive impairments.Check my eligibility
What is being tested?
The study is testing new non-invasive neurostimulation technologies—Active TI-NDBS and tDCS—against a sham (placebo) intervention to treat opioid use disorders by targeting specific brain regions. The goal is to disrupt addiction behaviorally and neurally as groundwork for future clinical trials.See study design
What are the potential side effects?
While the trial description does not specify side effects directly related to the interventions being tested (TI-NDBS & tDCS), similar neurostimulation treatments may cause discomfort at the stimulation site, headache, dizziness or nausea during or after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within the first year of testing ti-ndbs in nicotine smokers.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the first year of testing ti-ndbs in nicotine smokers.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Nicotine craving
Nicotine
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Phase 4 TI-NDBSExperimental Treatment1 Intervention
Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation for 60 minutes for 5 days and will be compared to sham stimulation and tDCS.
Group II: Phase 3 Active TI-NDBSExperimental Treatment1 Intervention
Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation. Participants will receive stimulation for 60 minutes on one day.
Group III: Phase 4 Traditional tDCSActive Control1 Intervention
Participants assigned to this condition will receive traditional transcranial direct current stimulation for 60 minutes for 5 days.
Group IV: Phase 4 Sham stimulationPlacebo Group1 Intervention
Participants assigned to this condition will receive sham temporal interference non-invasive deep brain stimulation, in which they will have electrodes attached to the scalp but the device is only turned on for a few seconds. Participants will be in the scanner for 60 minutes for 5 days. This will be used as the control condition and compared with TI-NDBS and tDCS.
Group V: Phase 3 Sham TI-NDBSPlacebo Group1 Intervention
Participants assigned to this condition will receive sham temporal interference non-invasive deep brain stimulation, in which they will have electrodes attached to the scalp but the device is only turned on for a few seconds.
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,971 Total Patients Enrolled
Indiana University School of MedicineOTHER
185 Previous Clinical Trials
142,693 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to smoke at least 15 cigarettes per day.I am on medication for ADHD, mental illness, cancer, epilepsy, migraines, neurological syndromes, or AIDS.You have had holes or openings made in your skull in the past, or you have known cracks or breaks in the bones of your head.I weigh less than 440 lbs.I am between 18 and 40 years old.You have a pacemaker implanted in your body.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 4 TI-NDBS
- Group 2: Phase 3 Active TI-NDBS
- Group 3: Phase 4 Sham stimulation
- Group 4: Phase 3 Sham TI-NDBS
- Group 5: Phase 4 Traditional tDCS
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are adults aged 50 and over eligible for this clinical trial?
"The criteria to be a part of this medical experiment necessitates that participants are between 18-40 years old. There are 325 trials available for those younger than 18 and 882 studies open to seniors over 65."
Answered by AI
Are there any opportunities for volunteers to participate in this clinical endeavor presently?
"Based on the information hosted by clinicaltrials.gov, this medical trial is not recruiting patients as of now; it was last updated on May 19th 2022 and initially posted November 25 2019. However, there are presently 1,319 other studies actively seeking participants."
Answered by AI
Do I meet the criteria to participate in this research endeavor?
"To be included in this nicotine-related clinical trial, an individual must have a diagnosed use disorder and lie between 18 to 40 years old. This medical experiment is accepting up to one hundred patients."
Answered by AI
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