Nicotine Use DisorderNCT07210268
Temporal Interference Methods for Addiction Treatment
A study testing TI-NDBS in people with Nicotine Use Disorder and Substance Use Disorders, run by Indiana University at 2 sites in United States.
Trial summary
This clinical study is testing whether a new non-invasive brain stimulation method, called temporal interference (TI), can reduce nicotine cravings and usage in people who vape. TI delivers mild electrical currents to the scalp in a way that targets deep brain areas involved in addiction, without the need for surgery. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Use Disorder, Substance Use Disorders
- What is being tested?
- TI-NDBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jan 2026to 27 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 21 and 50
- Nicotine dependent and vape at least 15 mg nicotine per day
- Must have a phone with internet access
- Participants must have at least a 6th grade education and be able to speak and read English
Who cannot join
- History of seizures, seizure disorders, or familial history of seizure disorders
- History of intractable migraine or complicated migraine syndromes
- History of suicide attempts or active suicidal ideation (past month)
- History of cardiac arrhythmias, prolonged QT, pacemakers, or cardiovascular disorders
- Hypertension with systolic BP >150mmHgCentral nervous system structural lesions (tumors, MS, strokes, etc.)
- Active neuropsychiatric disorders (schizophrenia, bipolar, active psychosis, dementia, etc.)
Show all 13Show fewer
- History of head trauma with loss of consciousness, skull fractures, subdural hematomas
- Active opioid, cocaine, and/or methamphetamine use
- Active severe cannabis use disorder
- Active alcohol use disorder or history of alcohol withdrawal
- Metal implants in the head or under the scalp (excluding dental implants)
- Current smoking cessation treatment or medications affecting reward processing
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Indiana University
Bloomington, Indiana, 47403
Joshua Brown, PhD, 812-855-9282, jwmbrown@iu.edu
- Recruiting
Indiana University School of Medicine - Goodman Hall
Indianapolis, Indiana, 46202
Joshua w Brown, PhD, 8128559282, cclab@iu.edu
Irene Jang, BS, 812-856-1846, cclabmgr@iu.edu
About this study
This clinical study is testing whether a new non-invasive brain stimulation method, called temporal interference (TI), can reduce nicotine cravings and usage in people who vape. TI delivers mild electrical currents to the scalp in a way that targets deep brain areas involved in addiction, without the need for surgery.
In this randomized controlled trial, participants will be assigned to one of three groups: TI stimulation to the nucleus accumbens, TI stimulation to the anterior insula, or a placebo (sham) condition. Each participant will attend a single stimulation session after 8 hours of nicotine abstinence and will use a custom vape device that measures real-time nicotine inhalation. Craving levels will be reported during and after the session.
The study aims to determine whether TI to the insula or nucleus accumbens is more effective at decreasing cravings and nicotine inhalation, and whether either is more effective than sham stimulation. For one week after the session, participants will use a smartphone app to track nicotine use and cravings. The primary hypothesis is that TI stimulation to deep brain regions will reduce both nicotine craving and actual use, immediately after stimulation and over the following week, compared to the sham condition.
Read the detailed description
Substance use disorders (SUDs) are difficult to treat effectively, with high relapse rates despite behavioral and pharmacological interventions. Previous clinical and case studies have shown that direct stimulation of deep brain regions-including the nucleus accumbens (NAcc) and anterior insula (AI)-can produce rapid, sustained reductions in addictive behaviors. Deep brain stimulation (DBS) of the NAcc has resulted in remission of opioid and alcohol use, while disruption of the AI has led to spontaneous loss of cigarette addiction. Although highly effective, DBS is invasive, expensive, and inaccessible to most patients. This randomized controlled clinical trial will evaluate whether temporal interference non-invasive deep brain stimulation (TI-NDBS) to the NAcc or AI can modulate deep brain activity and reduce nicotine craving and use in individuals who vape nicotine. TI uses two high-frequency electrical currents that intersect to create a low-frequency envelope capable of stimulating deep brain structures while sparing the overlying cortex. Pilot studies conducted by the investigators have shown that TI can safely and effectively activate the NAcc, as confirmed by increased BOLD signal during fMRI. In this study, 120 to 150 nicotine-dependent adults will be randomized to receive TI to the NAcc, TI to the AI, or sham stimulation. All participants will abstain from nicotine for at least 8 hours prior to the session, then undergo 60 minutes of stimulation while using a custom vape device that measures vapor inhalation in real time. Craving will be self-reported every 10 minutes. The primary outcome is a reduction in craving or nicotine use during the stimulation session. Secondary outcomes include changes in craving and use over the following week, assessed via ecological momentary assessment (EMA) three times daily using a smartphone app. Participants will also complete pre- and post-session assessments of cognitive function, emotional state, and stimulation experience. TI stimulation will be delivered with gradual current ramping to reduce discomfort, and previous pilot data support its tolerability. Findings from this study will provide early evidence of the safety and efficacy of TI-NDBS as a novel, low-cost, and scalable treatment for nicotine dependence, with potential applications in other addiction and psychiatric disorders involving deep brain circuitry.
- Conditions
- Nicotine Use Disorder, Substance Use Disorders
- Being tested
- TI-NDBS, Sham TI-NDBS
- Keywords
- Nicotine Addiction, Non-invasive deep brain stimulation, Substance Use Disorders, Temporal Interference Stimulation, BOLD Activation
- Medical subject headings
- Tobacco Use Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TI-NDBSDevice
Also called Temporal Interference Non-invasive Deep Brain Stimulation
In the active TI-NDBS condition, participants receive transcranial stimulation for 60 minutes through scalp electrodes using temporal interference (TI). Two electrode sets deliver high-frequency alternating currents (e.g., 2000 Hz and 2020 Hz), generating a 20 Hz beat frequency at depth to stimulate targeted brain regions. Stimulation is delivered in six 10-minute blocks with 30-second ramp-up and ramp-down periods to minimize discomfort. Electrode configurations differ by group to target either the nucleus accumbens or anterior insula, based on finite element modeling. The maximum current is up to 5 mA per electrode, and no single region receives more than 5 mA.
Sham TI-NDBSDevice
This is the control condition in which participants will receive sham stimulation for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| TI Stimulation - Nucleus Accumbens | Experimental | Participants in this arm will receive 60 minutes of temporal interference (TI) stimulation targeted to the nucleus accumbens (NAcc). TI will be delivered using two electrode sets, with placement determined to optimize stimulation of this region. Stimulation will use up to 5 mA per electrode at carrier frequencies of 2000 Hz and 2020 Hz, producing a 20 Hz beat frequency. Craving ratings will be collected every 10 minutes, and nicotine vapor use will be measured in real time. Receives: Device: TI-NDBS |
| TI Stimulation - Anterior Insula | Experimental | Participants in this arm will receive 60 minutes of temporal interference (TI) stimulation targeted to the anterior insula (AI). TI will be delivered using two electrode sets, with placement determined to optimize stimulation of this region. Stimulation will use up to 5 mA per electrode pair at carrier frequencies of 2000 Hz and 2020 Hz, producing a 20 Hz beat frequency. Craving ratings will be collected every 10 minutes, and nicotine vapor use will be measured in real time. Receives: Device: TI-NDBS |
| Sham Stimulation | Sham comparator | Participants in this arm will receive sham temporal interference (TI) stimulation that mimics the initial sensation of active stimulation. The current will ramp up over 30 seconds and immediately ramp back down, with no sustained current. This procedure controls for sensory experience and participant expectations. Electrode placement will mirror that used in the active conditions. Participants will complete the same craving assessments and use the same custom vape device as in the experimental arms. Receives: Device: Sham TI-NDBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nicotine Craving From Baseline to End of Stimulation Session
Nicotine craving will be assessed using a 1-10 Likert scale (1 = no craving, 10 = extremely strong craving) administered every 10 minutes during the 60-minute temporal interference (TI) stimulation session. The primary outcome is the change in self-reported craving from baseline (pre-stimulation) to the final rating at the 60-minute time point. This measure will assess the immediate effect of TI stimulation targeting either the nucleus accumbens or anterior insula on nicotine craving relative to sham stimulation.
Measured: Baseline to 60 minutes post-stimulation initiation (during the single stimulation session)
Change in Nicotine Vapor Inhalation Volume From Baseline to End of 60-Minute Stimulation Session
Nicotine use will be assessed using a custom vape device that continuously measures the volume of inhaled vapor during the 60-minute stimulation session. The primary outcome is the change in total vapor volume compared to baseline, assessed across all three groups (NAcc, anterior insula, and sham).
Measured: Baseline to 60 minutes post-stimulation initiation
Secondary outcomes (2)
Change in Self-Reported Nicotine Craving Over 7-Day Post-Stimulation Period
Participants will report nicotine craving levels three times daily using ecological momentary assessment (EMA) via a smartphone app for seven days following the stimulation session. Ratings will use a 1-10 Likert scale, and group differences will be analyzed to assess lasting effects of stimulation.
Measured: Daily for 7 days post-stimulation
Change in Self-Reported Nicotine Use Frequency Over 7-Day Post-Stimulation Period
Participants will self-report frequency of nicotine vaping or cigarette use three times daily via EMA for 7 days following the stimulation session. Daily use will be compared across groups to assess sustained effects on nicotine consumption.
Measured: Daily for 7 days post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start22 Jan 2026
- Primary completion20 Feb 2027 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nicotine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three groups: temporal interference stimulation to the nucleus accumbens, temporal interference stimulation to the anterior insula, or sham stimulation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Joshua Brown, PHD, Indiana University
- Investigators
- Joshua Brown, Principal investigator, Indiana University, Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210268
- Sponsor's protocol ID
- 27333
- Other IDs
- 1R21DA062805-01
- Status last verified
- Feb 2026
- First submitted
- 29 Sep 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Modak P, Fine J, Colon B, Need E, Cheng H, Hulvershorn L, Finn P, Brown JW. Temporal interference electrical neurostimulation at 20 Hz beat frequency leads to increased fMRI BOLD activation in orbitofrontal cortex in humans. Brain Stimul. 2024 Jul-Aug;17(4):867-875. doi: 10.1016/j.brs.2024.07.014. Epub 2024 Jul 24.
PubMed 39059712Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.
PubMed 28575667Violante IR, Alania K, Cassara AM, Neufeld E, Acerbo E, Carron R, Williamson A, Kurtin DL, Rhodes E, Hampshire A, Kuster N, Boyden ES, Pascual-Leone A, Grossman N. Publisher Correction: Non-invasive temporal interference electrical stimulation of the human hippocampus. Nat Neurosci. 2023 Dec;26(12):2252. doi: 10.1038/s41593-023-01517-y. No abstract available.
PubMed 37957321Naqvi NH, Rudrauf D, Damasio H, Bechara A. Damage to the insula disrupts addiction to cigarette smoking. Science. 2007 Jan 26;315(5811):531-4. doi: 10.1126/science.1135926.
PubMed 17255515Wessel MJ, Beanato E, Popa T, Windel F, Vassiliadis P, Menoud P, Beliaeva V, Violante IR, Abderrahmane H, Dzialecka P, Park CH, Maceira-Elvira P, Morishita T, Cassara AM, Steiner M, Grossman N, Neufeld E, Hummel FC. Noninvasive theta-burst stimulation of the human striatum enhances striatal activity and motor skill learning. Nat Neurosci. 2023 Nov;26(11):2005-2016. doi: 10.1038/s41593-023-01457-7. Epub 2023 Oct 19.
PubMed 37857774Joutsa J, Moussawi K, Siddiqi SH, Abdolahi A, Drew W, Cohen AL, Ross TJ, Deshpande HU, Wang HZ, Bruss J, Stein EA, Volkow ND, Grafman JH, van Wijngaarden E, Boes AD, Fox MD. Brain lesions disrupting addiction map to a common human brain circuit. Nat Med. 2022 Jun;28(6):1249-1255. doi: 10.1038/s41591-022-01834-y. Epub 2022 Jun 13.
PubMed 35697842
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Interference Methods for Addiction Treatment
- ClinicalTrials.gov ID
- NCT07210268
- Acronym / sponsor ID
- 27333
- Conditions
- Nicotine Use Disorder, Substance Use Disorders
- Keywords
- Nicotine Addiction, Non-invasive deep brain stimulation, Substance Use Disorders, Temporal Interference Stimulation, BOLD Activation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is testing whether a new non-invasive brain stimulation method, called temporal interference (TI), can reduce nicotine cravings and usage in people who vape. TI delivers mild electrical currents to the scalp in a way that targets deep brain areas involved in addiction, without the need for surgery.
In this randomized controlled trial, participants will be assigned to one of three groups: TI stimulation to the nucleus accumbens, TI stimulation to the anterior insula, or a placebo (sham) condition. Each participant will attend a single stimulation session after 8 hours of nicotine abstinence and will use a custom vape device that measures real-time nicotine inhalation. Craving levels will be reported during and after the session.
The study aims to determine whether TI to the insula or nucleus accumbens is more effective at decreasing cravings and nicotine inhalation, and whether either is more effective than sham stimulation. For one week after the session, participants will use a smartphone app to track nicotine use and cravings. The primary hypothesis is that TI stimulation to deep brain regions will reduce both nicotine craving and actual use, immediately after stimulation and over the following week, compared to the sham condition.
Detailed description
Substance use disorders (SUDs) are difficult to treat effectively, with high relapse rates despite behavioral and pharmacological interventions. Previous clinical and case studies have shown that direct stimulation of deep brain regions-including the nucleus accumbens (NAcc) and anterior insula (AI)-can produce rapid, sustained reductions in addictive behaviors. Deep brain stimulation (DBS) of the NAcc has resulted in remission of opioid and alcohol use, while disruption of the AI has led to spontaneous loss of cigarette addiction. Although highly effective, DBS is invasive, expensive, and inaccessible to most patients. This randomized controlled clinical trial will evaluate whether temporal interference non-invasive deep brain stimulation (TI-NDBS) to the NAcc or AI can modulate deep brain activity and reduce nicotine craving and use in individuals who vape nicotine. TI uses two high-frequency electrical currents that intersect to create a low-frequency envelope capable of stimulating deep brain structures while sparing the overlying cortex. Pilot studies conducted by the investigators have shown that TI can safely and effectively activate the NAcc, as confirmed by increased BOLD signal during fMRI. In this study, 120 to 150 nicotine-dependent adults will be randomized to receive TI to the NAcc, TI to the AI, or sham stimulation. All participants will abstain from nicotine for at least 8 hours prior to the session, then undergo 60 minutes of stimulation while using a custom vape device that measures vapor inhalation in real time. Craving will be self-reported every 10 minutes. The primary outcome is a reduction in craving or nicotine use during the stimulation session. Secondary outcomes include changes in craving and use over the following week, assessed via ecological momentary assessment (EMA) three times daily using a smartphone app. Participants will also complete pre- and post-session assessments of cognitive function, emotional state, and stimulation experience. TI stimulation will be delivered with gradual current ramping to reduce discomfort, and previous pilot data support its tolerability. Findings from this study will provide early evidence of the safety and efficacy of TI-NDBS as a novel, low-cost, and scalable treatment for nicotine dependence, with potential applications in other addiction and psychiatric disorders involving deep brain circuitry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three groups: temporal interference stimulation to the nucleus accumbens, temporal interference stimulation to the anterior insula, or sham stimulation.
| Arm | Type | Receives |
|---|---|---|
| TI Stimulation - Nucleus Accumbens | Experimental | Device: TI-NDBSParticipants in this arm will receive 60 minutes of temporal interference (TI) stimulation targeted to the nucleus accumbens (NAcc). TI will be delivered using two electrode sets, with placement determined to optimize stimulation of this region. Stimulation will use up to 5 mA per electrode at carrier frequencies of 2000 Hz and 2020 Hz, producing a 20 Hz beat frequency. Craving ratings will be collected every 10 minutes, and nicotine vapor use will be measured in real time. |
| TI Stimulation - Anterior Insula | Experimental | Device: TI-NDBSParticipants in this arm will receive 60 minutes of temporal interference (TI) stimulation targeted to the anterior insula (AI). TI will be delivered using two electrode sets, with placement determined to optimize stimulation of this region. Stimulation will use up to 5 mA per electrode pair at carrier frequencies of 2000 Hz and 2020 Hz, producing a 20 Hz beat frequency. Craving ratings will be collected every 10 minutes, and nicotine vapor use will be measured in real time. |
| Sham Stimulation | Sham comparator | Device: Sham TI-NDBSParticipants in this arm will receive sham temporal interference (TI) stimulation that mimics the initial sensation of active stimulation. The current will ramp up over 30 seconds and immediately ramp back down, with no sustained current. This procedure controls for sensory experience and participant expectations. Electrode placement will mirror that used in the active conditions. Participants will complete the same craving assessments and use the same custom vape device as in the experimental arms. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 21 and 50
- Nicotine dependent and vape at least 15 mg nicotine per day
- Must have a phone with internet access
- Participants must have at least a 6th grade education and be able to speak and read English
Key exclusion criteria (13 listed)
- History of seizures, seizure disorders, or familial history of seizure disorders
- History of intractable migraine or complicated migraine syndromes
- History of suicide attempts or active suicidal ideation (past month)
- History of cardiac arrhythmias, prolonged QT, pacemakers, or cardiovascular disorders
- Hypertension with systolic BP >150mmHgCentral nervous system structural lesions (tumors, MS, strokes, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TI-NDBSAlso: Temporal Interference Non-invasive Deep Brain StimulationIn the active TI-NDBS condition, participants receive transcranial stimulation for 60 minutes through scalp electrodes using temporal interference (TI). Two electrode sets deliver high-frequency alternating currents (e.g., 2000 Hz and 2020 Hz), generating a 20 Hz beat frequency at depth to stimulate targeted brain regions. Stimulation is delivered in six 10-minute blocks with 30-second ramp-up and ramp-down periods to minimize discomfort. Electrode configurations differ by group to target either the nucleus accumbens or anterior insula, based on finite element modeling. The maximum current is up to 5 mA per electrode, and no single region receives more than 5 mA. | Device | TI Stimulation - Anterior Insula, TI Stimulation - Nucleus Accumbens |
| Sham TI-NDBSThis is the control condition in which participants will receive sham stimulation for 60 minutes. | Device | Sham Stimulation |
Primary outcome
Change in Nicotine Craving From Baseline to End of Stimulation Session
Time frame: Baseline to 60 minutes post-stimulation initiation (during the single stimulation session)
Nicotine craving will be assessed using a 1-10 Likert scale (1 = no craving, 10 = extremely strong craving) administered every 10 minutes during the 60-minute temporal interference (TI) stimulation session. The primary outcome is the change in self-reported craving from baseline (pre-stimulation) to the final rating at the 60-minute time point. This measure will assess the immediate effect of TI stimulation targeting either the nucleus accumbens or anterior insula on nicotine craving relative to sham stimulation.
Change in Nicotine Vapor Inhalation Volume From Baseline to End of 60-Minute Stimulation Session
Time frame: Baseline to 60 minutes post-stimulation initiation
Nicotine use will be assessed using a custom vape device that continuously measures the volume of inhaled vapor during the 60-minute stimulation session. The primary outcome is the change in total vapor volume compared to baseline, assessed across all three groups (NAcc, anterior insula, and sham).
2 secondary outcomes
Change in Self-Reported Nicotine Craving Over 7-Day Post-Stimulation Period
Time frame: Daily for 7 days post-stimulation
Change in Self-Reported Nicotine Use Frequency Over 7-Day Post-Stimulation Period
Time frame: Daily for 7 days post-stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 39059712Modak P, Fine J, Colon B, Need E, Cheng H, Hulvershorn L, Finn P, Brown JW. Temporal interference electrical neurostimulation at 20 Hz beat frequency leads to increased fMRI BOLD activation in orbitofrontal cortex in humans. Brain Stimul. 2024 Jul-Aug;17(4):867-875. doi: 10.1016/j.brs.2024.07.014. Epub 2024 Jul 24.
- Background: PubMed 28575667Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.
- Background: PubMed 37957321Violante IR, Alania K, Cassara AM, Neufeld E, Acerbo E, Carron R, Williamson A, Kurtin DL, Rhodes E, Hampshire A, Kuster N, Boyden ES, Pascual-Leone A, Grossman N. Publisher Correction: Non-invasive temporal interference electrical stimulation of the human hippocampus. Nat Neurosci. 2023 Dec;26(12):2252. doi: 10.1038/s41593-023-01517-y. No abstract available.
- Background: PubMed 17255515Naqvi NH, Rudrauf D, Damasio H, Bechara A. Damage to the insula disrupts addiction to cigarette smoking. Science. 2007 Jan 26;315(5811):531-4. doi: 10.1126/science.1135926.
- Background: PubMed 37857774Wessel MJ, Beanato E, Popa T, Windel F, Vassiliadis P, Menoud P, Beliaeva V, Violante IR, Abderrahmane H, Dzialecka P, Park CH, Maceira-Elvira P, Morishita T, Cassara AM, Steiner M, Grossman N, Neufeld E, Hummel FC. Noninvasive theta-burst stimulation of the human striatum enhances striatal activity and motor skill learning. Nat Neurosci. 2023 Nov;26(11):2005-2016. doi: 10.1038/s41593-023-01457-7. Epub 2023 Oct 19.
- Background: PubMed 35697842Joutsa J, Moussawi K, Siddiqi SH, Abdolahi A, Drew W, Cohen AL, Ross TJ, Deshpande HU, Wang HZ, Bruss J, Stein EA, Volkow ND, Grafman JH, van Wijngaarden E, Boes AD, Fox MD. Brain lesions disrupting addiction map to a common human brain circuit. Nat Med. 2022 Jun;28(6):1249-1255. doi: 10.1038/s41591-022-01834-y. Epub 2022 Jun 13.
- NIH Reporter Project PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Brown principal investigator
Indiana University, Bloomington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TI-NDBS in people with Nicotine Use Disorder and Substance Use Disorders, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Brown, PhD (812-855-9282, cclab@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nicotine Craving From Baseline to End of Stimulation Session (time frame: Baseline to 60 minutes post-stimulation initiation (during the single stimulation session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210268, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.