Nicotine Use DisorderNCT04432064

Temporal Interference Neurostimulation and Addiction

A study testing Active TI-NDBS and tDCS in people with Nicotine Use Disorder and Substance Use Disorders, run by Indiana University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Nicotine Use Disorder, Substance Use Disorders
What is being tested?: Active TI-NDBS and tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 6 Jul 2020to 21 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Must be between the ages of 18 and 50, must have at least 6th grade education, and the ability to speak and read English, must smoke at least 3/4 of a pack of cigarettes per day, must have phone with internet access.

Who cannot join

if they are on psychotropic medications for ADHD, other mental illness or medication for cancer, epilepsy (i.e. individuals with any history of seizure disorder), migraines, or other neurological syndromes, or AIDs (which can cause cognitive deficits (Watkins \& Treisman, 2015), history of head trauma, history of cognitive impairments, metal implants in the head or under the scalp, personal experiences consistent with symptoms of psychosis (i.e. mind or body being secretly controlled, special powers, seeing or hearing things that aren't really there).
Subjects will be excluded if they do not meet fMRI safety screening criteria (i.e. metal implants in their body, tattoo on head or neck, permanent jewelry, etc.) or if a participant uses an IUD for birth control they will be excluded unless the subject can document the model of the IUD and we can verify its safety for the MRI environment. Pregnancy should be self-reported, and a pregnancy test will not be administered. Participants must also weigh less than 440 lbs.
History of holes bored into skull or known fissures in cranial bones
Presence of pacemakers

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University
Bloomington, Indiana, 47403

Other trials in United States

About this study

This project aims to develop a line of research using new non-invasive neurostimulation technology to treat adults with opioid use disorders (OUDs). In the short term, the investigators aim to identify novel target brain regions for neurostimulation treatment and characterize their effects behaviorally and neurally. In the longer term, investigators aim to use these preliminary data to justify NIH sponsored clinical trials to apply transcranial direct current stimulation and non-invasive deep brain stimulation to these areas to partially or completely disrupt addiction.

Read the detailed description

The investigators hypothesize that temporal interference non-invasive deep brain stimulation (TI-NDBS) will be well tolerated and effective at manipulating brain activity and reducing drug cravings. The investigators will investigate whether stimulation with a mild current from temporal interference non-invasive deep brain stimulation (TI-NDBS) to the Anterior Cingulate Cortex (ACC), the anterior insula (AI), or the nucleus accumbens (NAcc) will reduce nicotine craving and seeking. The TI-NDBS is similar to the traditional transcranial direct current stimulation (tDCS), a method approved for use in a number of other studies. Other studies have shown there have been some effects of reducing craving with tDCS, however, tDCS cannot stimulate structures such as the ACC very effectively because tDCS cannot stimulate deeper brain regions. Thus, the Specific Aim ultimately will compare TI-NDBS with tDCS and sham stimulation. The study is broken up into four phases. The first two will involve device feasibility and identifying the best locations for the electrodes to be placed. In the third phase, the investigators will compare TI-NDBS with sham stimulation. In the fourth phase, the investigators will compare TI-NDBS with sham stimulation and with tDCS.

Conditions: Nicotine Use Disorder, Substance Use Disorders
Being tested: Active TI-NDBS, Sham TI-NDBS, tDCS
Keywords: Nicotine Addiction, Non-invasive deep brain stimulation, Substance Use Disorders
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.

Active TI-NDBSDevice
Also called Temporal Interference Non-invasive Deep Brain Stimulation
In the active TI-NDBS condition, subjects will receive stimulation for 60 minutes applied to the brain through scalp electrodes. There will be a maximum of 2 mA per electrode pair and no single region will receive more than 2 mA because the currents will be administered to distinct regions. At the beginning of each stimulation period, the current will increase slowly at a constant rate for 30 seconds until it reaches the appropriate intensity. At the end of the stimulation, the current will decrease slowly for 30 seconds until it reaches zero.
Sham TI-NDBSOther
This is the control condition in which participants will receive sham stimulation for 60 minutes.
tDCSDevice
This is a well established method of brain stimulation and will be used to compare against the efficacy of TI-NDBS in the reduction of nicotine craving and inhalation. Participants will receive stimulation for 60 minutes.

Study groups in NCT04432064
Study group	Role	What they receive
Phase 3 Active TI-NDBS	Experimental	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. Receives: Device: Active TI-NDBS
Phase 3 Sham TI-NDBS	Sham comparator	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. Receives: Other: Sham TI-NDBS
Phase 4 Traditional tDCS	Active comparator	Participants assigned to this condition will receive traditional transcranial direct current stimulation for 60 minutes for 5 days. Receives: Device: tDCS
Phase 4 TI-NDBS	Experimental	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. Receives: Device: Active TI-NDBS
Phase 4 Sham stimulation	Sham comparator	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. Receives: Other: Sham TI-NDBS

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Nicotine Craving
The investigators predict that TI-NDBS will outperform sham stimulation at an overall change in smoking and cigarette craving, which in turn will outperform sham stimulation. The investigators will sum the total inhaled nicotine vapor volume in liters over the 60 minute session and perform pairwise t-tests to determine if total drug intake is lower with TI-NDBS vs tDCS. Also, the investigators will average the self reported craving levels on a Likert scale across each subject during the 60 minute session, and the investigators will perform pairwise tests to determine if stimulation lowers self reported craving. The Likert scale is 0-10, where 10 is maximum craving. The units are units on a scale. The outcome measure is computed by taking the pre-stimulation craving and subtracting the post-stimulation craving. Positive numbers indicate the degree to which the self-reported craving was reduced after the stimulation relative to before stimulation
Measured: Each subject was asked to report their craving during the day of the session, before and after the stimulation. Approximately one hour elapsed between before and after nicotine craving measurements. The session was carried out during the daytime.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 202021 Apr 2022

First posted16 Jun 2020
Study start6 Jul 2020
Primary completion21 Apr 2022
Study completion21 Apr 2022

Why it stopped: Covid pandemic restrictions delayed data collection and led to loss of funding.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)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: One group of 20 participants will receive active TI-NDBS and another group of 20 participants will receive sham TI-NDBS. A third group of 20 participants will receive traditional transcranial direct current stimulation (tDCS).
Masking: Single blind
Who is masked: Participant
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04432064
Sponsor's protocol ID: 1904451651
Status last verified: Jun 2025
First submitted: 5 Jun 2020
Last updated: 24 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: We will share anonymized participant data upon request. Beyond that, we will report anonymized data publicly in aggregate.

Publications

Fregni F, Liguori P, Fecteau S, Nitsche MA, Pascual-Leone A, Boggio PS. Cortical stimulation of the prefrontal cortex with transcranial direct current stimulation reduces cue-provoked smoking craving: a randomized, sham-controlled study. J Clin Psychiatry. 2008 Jan;69(1):32-40. doi: 10.4088/jcp.v69n0105.
PubMed 18312035
Grossman 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 28575667
Fecteau S, Agosta S, Hone-Blanchet A, Fregni F, Boggio P, Ciraulo D, Pascual-Leone A. Modulation of smoking and decision-making behaviors with transcranial direct current stimulation in tobacco smokers: a preliminary study. Drug Alcohol Depend. 2014 Jul 1;140:78-84. doi: 10.1016/j.drugalcdep.2014.03.036. Epub 2014 Apr 16.
PubMed 24814566
Hulvershorn LA, Hummer TA, Fukunaga R, Leibenluft E, Finn P, Cyders MA, Anand A, Overhage L, Dir A, Brown J. Neural activation during risky decision-making in youth at high risk for substance use disorders. Psychiatry Res. 2015 Aug 30;233(2):102-11. doi: 10.1016/j.pscychresns.2015.05.007. Epub 2015 May 21.
PubMed 26071624
Wing VC, Barr MS, Wass CE, Lipsman N, Lozano AM, Daskalakis ZJ, George TP. Brain stimulation methods to treat tobacco addiction. Brain Stimul. 2013 May;6(3):221-30. doi: 10.1016/j.brs.2012.06.008. Epub 2012 Jul 9.
PubMed 22809824
Velez de Mendizabal N, Jones DR, Jahn A, Bies RR, Brown JW. Nicotine and cotinine exposure from electronic cigarettes: a population approach. Clin Pharmacokinet. 2015 Jun;54(6):615-26. doi: 10.1007/s40262-014-0221-7.
PubMed 25503588
Naqvi 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 17255515
Naqvi NH, Gaznick N, Tranel D, Bechara A. The insula: a critical neural substrate for craving and drug seeking under conflict and risk. Ann N Y Acad Sci. 2014 May;1316:53-70. doi: 10.1111/nyas.12415. Epub 2014 Apr 1.
PubMed 24690001
Muller UJ, Sturm V, Voges J, Heinze HJ, Galazky I, Heldmann M, Scheich H, Bogerts B. Successful treatment of chronic resistant alcoholism by deep brain stimulation of nucleus accumbens: first experience with three cases. Pharmacopsychiatry. 2009 Nov;42(6):288-91. doi: 10.1055/s-0029-1233489. Epub 2009 Nov 18. No abstract available.
PubMed 19924591
Craig AD. How do you feel? Interoception: the sense of the physiological condition of the body. Nat Rev Neurosci. 2002 Aug;3(8):655-66. doi: 10.1038/nrn894.
PubMed 12154366

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Nicotine Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Temporal Interference Neurostimulation and Addiction
ClinicalTrials.gov ID: NCT04432064
Acronym / sponsor ID: 1904451651
Conditions: Nicotine Use Disorder, Substance Use Disorders
Keywords: Nicotine Addiction, Non-invasive deep brain stimulation, Substance Use Disorders
Study type: Interventional
Recruitment status: TerminatedReason stopped: Covid pandemic restrictions delayed data collection and led to loss of funding.
Enrolment: 10 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: 6 Jul 2020 (actual)
Primary completion: 21 Apr 2022 (actual)
Study completion: 21 Apr 2022 (actual)
First posted: 16 Jun 2020 (actual)
Results: Posted 24 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5
Model description: One group of 20 participants will receive active TI-NDBS and another group of 20 participants will receive sham TI-NDBS. A third group of 20 participants will receive traditional transcranial direct current stimulation (tDCS).

Arm	Type	Receives
Phase 3 Active TI-NDBS	Experimental	Device: Active TI-NDBSParticipants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation. Participants will receive stimulation for 60 minutes on one day.
Phase 3 Sham TI-NDBS	Sham comparator	Other: Sham TI-NDBSParticipants 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.
Phase 4 Traditional tDCS	Active comparator	Device: tDCSParticipants assigned to this condition will receive traditional transcranial direct current stimulation for 60 minutes for 5 days.
Phase 4 TI-NDBS	Experimental	Device: Active TI-NDBSParticipants 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.
Phase 4 Sham stimulation	Sham comparator	Other: Sham TI-NDBSParticipants 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.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Must be between the ages of 18 and 50, must have at least 6th grade education, and the ability to speak and read English, must smoke at least 3/4 of a pack of cigarettes per day, must have phone with internet access.

Key exclusion criteria (4 listed)

if they are on psychotropic medications for ADHD, other mental illness or medication for cancer, epilepsy (i.e. individuals with any history of seizure disorder), migraines, or other neurological syndromes, or AIDs (which can cause cognitive deficits (Watkins \& Treisman, 2015), history of head trauma, history of cognitive impairments, metal implants in the head or under the scalp, personal experiences consistent with symptoms of psychosis (i.e. mind or body being secretly controlled, special powers, seeing or hearing things that aren't really there).
Subjects will be excluded if they do not meet fMRI safety screening criteria (i.e. metal implants in their body, tattoo on head or neck, permanent jewelry, etc.) or if a participant uses an IUD for birth control they will be excluded unless the subject can document the model of the IUD and we can verify its safety for the MRI environment. Pregnancy should be self-reported, and a pregnancy test will not be administered. Participants must also weigh less than 440 lbs.
History of holes bored into skull or known fissures in cranial bones
Presence of pacemakers

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
Active TI-NDBSAlso: Temporal Interference Non-invasive Deep Brain StimulationIn the active TI-NDBS condition, subjects will receive stimulation for 60 minutes applied to the brain through scalp electrodes. There will be a maximum of 2 mA per electrode pair and no single region will receive more than 2 mA because the currents will be administered to distinct regions. At the beginning of each stimulation period, the current will increase slowly at a constant rate for 30 seconds until it reaches the appropriate intensity. At the end of the stimulation, the current will decrease slowly for 30 seconds until it reaches zero.	Device	Phase 3 Active TI-NDBS, Phase 4 TI-NDBS
Sham TI-NDBSThis is the control condition in which participants will receive sham stimulation for 60 minutes.	Other	Phase 3 Sham TI-NDBS, Phase 4 Sham stimulation
tDCSThis is a well established method of brain stimulation and will be used to compare against the efficacy of TI-NDBS in the reduction of nicotine craving and inhalation. Participants will receive stimulation for 60 minutes.	Device	Phase 4 Traditional tDCS

Primary outcome

Change in Nicotine Craving
Time frame: Each subject was asked to report their craving during the day of the session, before and after the stimulation. Approximately one hour elapsed between before and after nicotine craving measurements. The session was carried out during the daytime.
The investigators predict that TI-NDBS will outperform sham stimulation at an overall change in smoking and cigarette craving, which in turn will outperform sham stimulation. The investigators will sum the total inhaled nicotine vapor volume in liters over the 60 minute session and perform pairwise t-tests to determine if total drug intake is lower with TI-NDBS vs tDCS. Also, the investigators will average the self reported craving levels on a Likert scale across each subject during the 60 minute session, and the investigators will perform pairwise tests to determine if stimulation lowers self reported craving. The Likert scale is 0-10, where 10 is maximum craving. The units are units on a scale. The outcome measure is computed by taking the pre-stimulation craving and subtracting the post-stimulation craving. Positive numbers indicate the degree to which the self-reported craving was reduced after the stimulation relative to before stimulation

Results and safety

Results posted to the registry on 24 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 3 Active TI-NDBS	10	5
Phase 3 Sham TI-NDBS	0	0
Phase 4 Traditional tDCS	0	0
Phase 4 TI-NDBS	0	0
Phase 4 Sham Stimulation	0	0

Primary outcome: Change in Nicotine Craving

Time frame: Each subject was asked to report their craving during the day of the session, before and after the stimulation. Approximately one hour elapsed between before and after nicotine craving measurements. The session was carried out during the daytime.. Mean (Standard Deviation). Unit: reduction in nicotine craving on 10-pt

Measure	Phase 3 Active TI-NDBS n = 5
Value	4.25 (1.71)

Population analysed: Note the results here cannot be interpreted meaningfully as we were unable to run the control group, so there is no valid comparison.

Adverse events

Time frame: The total duration of collecting information about adverse events across subjects was 1 year, 5 months. Each individual subject was monitored for adverse events over a one day period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 3 Active TI-NDBS	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18312035Fregni F, Liguori P, Fecteau S, Nitsche MA, Pascual-Leone A, Boggio PS. Cortical stimulation of the prefrontal cortex with transcranial direct current stimulation reduces cue-provoked smoking craving: a randomized, sham-controlled study. J Clin Psychiatry. 2008 Jan;69(1):32-40. doi: 10.4088/jcp.v69n0105.
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 24814566Fecteau S, Agosta S, Hone-Blanchet A, Fregni F, Boggio P, Ciraulo D, Pascual-Leone A. Modulation of smoking and decision-making behaviors with transcranial direct current stimulation in tobacco smokers: a preliminary study. Drug Alcohol Depend. 2014 Jul 1;140:78-84. doi: 10.1016/j.drugalcdep.2014.03.036. Epub 2014 Apr 16.
Background: PubMed 26071624Hulvershorn LA, Hummer TA, Fukunaga R, Leibenluft E, Finn P, Cyders MA, Anand A, Overhage L, Dir A, Brown J. Neural activation during risky decision-making in youth at high risk for substance use disorders. Psychiatry Res. 2015 Aug 30;233(2):102-11. doi: 10.1016/j.pscychresns.2015.05.007. Epub 2015 May 21.
Background: PubMed 22809824Wing VC, Barr MS, Wass CE, Lipsman N, Lozano AM, Daskalakis ZJ, George TP. Brain stimulation methods to treat tobacco addiction. Brain Stimul. 2013 May;6(3):221-30. doi: 10.1016/j.brs.2012.06.008. Epub 2012 Jul 9.
Background: PubMed 25503588Velez de Mendizabal N, Jones DR, Jahn A, Bies RR, Brown JW. Nicotine and cotinine exposure from electronic cigarettes: a population approach. Clin Pharmacokinet. 2015 Jun;54(6):615-26. doi: 10.1007/s40262-014-0221-7.
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 24690001Naqvi NH, Gaznick N, Tranel D, Bechara A. The insula: a critical neural substrate for craving and drug seeking under conflict and risk. Ann N Y Acad Sci. 2014 May;1316:53-70. doi: 10.1111/nyas.12415. Epub 2014 Apr 1.
Background: PubMed 19924591Muller UJ, Sturm V, Voges J, Heinze HJ, Galazky I, Heldmann M, Scheich H, Bogerts B. Successful treatment of chronic resistant alcoholism by deep brain stimulation of nucleus accumbens: first experience with three cases. Pharmacopsychiatry. 2009 Nov;42(6):288-91. doi: 10.1055/s-0029-1233489. Epub 2009 Nov 18. No abstract available.
Background: PubMed 12154366Craig AD. How do you feel? Interoception: the sense of the physiological condition of the body. Nat Rev Neurosci. 2002 Aug;3(8):655-66. doi: 10.1038/nrn894.
Individual participant dataSharing planned: Yes. We will share anonymized participant data upon request. Beyond that, we will report anonymized data publicly in aggregate.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active TI-NDBS and tDCS in people with Nicotine Use Disorder and Substance Use Disorders, run by Indiana University at 1 site 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Nicotine Craving (time frame: Each subject was asked to report their craving during the day of the session, before and after the stimulation. Approximately one hour elapsed between before and after nicotine craving measurements. The session was carried out during the daytime.). 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 NCT04432064, which also lists 10 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 24 Jun 2025.