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Neurostimulation

Neurostimulation for Addiction

N/A
Recruiting
Research Sponsored by Indiana University
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
Must not have
Participants must also weigh less than 440 lbs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after the first primary outcome.
Awards & highlights

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 below
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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I weigh less than 440 lbs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the first year of testing ti-ndbs in nicotine smokers.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within the first year of testing ti-ndbs in nicotine smokers. 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 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Substance Use Disorder (SUD) that involve modulation of neural activity, such as Transcranial Direct Current Stimulation (tDCS) and Non-Invasive Deep Brain Stimulation (DBS), work by targeting specific brain regions involved in addiction and decision-making. These treatments aim to reduce cravings and improve cognitive control by altering the electrical activity in these areas. This is significant for SUD patients as it offers a non-invasive alternative to pharmacotherapy, potentially reducing side effects and improving treatment adherence.
Efficacy of transcranial direct current stimulation (tDCS) in reducing consumption in patients with alcohol use disorders: study protocol for a randomized controlled trial.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
997 Previous Clinical Trials
1,095,494 Total Patients Enrolled
Indiana University School of MedicineOTHER
186 Previous Clinical Trials
143,296 Total Patients Enrolled

Media Library

Active TI-NDBS (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04432064 — N/A
Substance Use Disorder Research Study Groups: Phase 4 TI-NDBS, Phase 3 Active TI-NDBS, Phase 4 Sham stimulation, Phase 3 Sham TI-NDBS, Phase 4 Traditional tDCS
Substance Use Disorder Clinical Trial 2023: Active TI-NDBS Highlights & Side Effects. Trial Name: NCT04432064 — N/A
Active TI-NDBS (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04432064 — N/A
~41 spots leftby May 2027