What side effects are associated with this type of intervention?

Transcranial Direct Current Stimulation (tDCS) and Non-Invasive Deep Brain Stimulation (DBS) are emerging neuromodulation techniques for treating Substance Use Disorder (SUD). Common side effects of tDCS include mild skin irritation at the electrode site, headache, dizziness, and a tingling sensation. Non-Invasive DBS, while less studied, may share similar side effects with invasive DBS, such as headache, mood changes, and in rare cases, seizures. Other common treatments for SUD, such as medications like naltrexone and varenicline, can cause nausea, headache, dizziness, and in some cases, neuropsychiatric symptoms like anxiety and depression.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for Substance Use Disorder (SUD), including methadone, buprenorphine, and naltrexone for opioid use disorder, and disulfiram, acamprosate, and naltrexone for alcohol use disorder. While pharmacological treatments are well-established, neuromodulation therapies like Transcranial Direct Current Stimulation (tDCS) and Non-Invasive Deep Brain Stimulation (DBS) are still under investigation and have not yet received FDA approval for SUD. These neuromodulation techniques aim to modulate neural activity in target brain regions to reduce addiction-related behaviors, but more research is needed to establish their efficacy and safety.

What other types of research exist?

Promising novel alternatives to tDCS and non-invasive DBS for treating Substance Use Disorder patients include: 1) Temporal Interference Neurostimulation, which aims to target specific brain regions non-invasively to disrupt addiction-related neural circuits. 2) High-Frequency Spinal Cord Stimulation (SCS), which has shown efficacy in treating chronic pain and may have potential applications in modulating neural activity related to addiction. 3) Non-invasive median and radial nerve stimulation, which has demonstrated effectiveness in reducing tremor and may be explored for its neuromodulatory effects in SUD.

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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 aims to help adults reduce their desire for drugs by using a gentle technique that affects the brain. The goal is to support existing treatments with fewer side effects and better commitment to the treatment plan.

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.

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.

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 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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

0 / 2Eligibility criteria met

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.