Nicotine DependenceNCT07698470
Brain/Craving Response to Smoking Cues After Oral Nicotine Pouch Use
A study testing Oral Nicotine Pouch and Smoking Cue Reactivity Task in people with Nicotine Dependence, run by University of Southern California at 1 site in United States.
Trial summary
Oral nicotine pouches (ONPs) are non-combustible nicotine products that may reduce cigarette craving and smoking cue-induced brain activity, supporting their potential as harm-reduction tools for adults who smoke cigarettes. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Oral Nicotine Pouch and Smoking Cue Reactivity Task
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21 years - 55 years
- Self-reported use of cigarettes within the past 30 days
- Biochemical confirmation of cigarette use:
- o Carbon monoxide (CO) breath sample ≥10 ppm
- Fagerström Test for Nicotine Dependence (FTND) score ≥5, indicating moderate to high nicotine dependence
- Fluent in English
- Willing to try an oral nicotine pouch
- Willing to abstain from nicotine for at least 12 hours prior to each experimental session
Who cannot join
- Age younger than 21 years or older than 55 years
- Biochemical evidence inconsistent with recent cigarette use:
- o CO breath sample <10 ppm
- Expressed intent to reduce or quit nicotine use within the next 30 days
- History of medical conditions contraindicated for nicotine use (e.g., uncontrolled hypertension, recent cardiac events)
- Primary use of non-cigarette products (e.g., cigars, pipe tobacco, smokeless tobacco)
- Prior use of oral nicotine products in their lifetime
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California - 3641 Watt Way (HNB B22)
Los Angeles, California, 90089
USC Nicotine and Tobacco Studies, 213-821-0807, USCONPStudy@gmail.com
About this study
Official title: Cue-Exposure Response Evaluation: Brain Reactivity to ONPs
Oral nicotine pouches (ONPs) are non-combustible nicotine products that may reduce cigarette craving and smoking cue-induced brain activity, supporting their potential as harm-reduction tools for adults who smoke cigarettes. This within-subject, repeated-measures study will evaluate the acute effects of a single 6 mg oral nicotine pouch on subjective craving and prefrontal neural responses to smoking-related cues using functional near-infrared spectroscopy (fNIRS). Participants will complete assessments before and after nicotine pouch administration following overnight nicotine abstinence to characterize changes in craving and neural cue reactivity.
Read the detailed description
This study will evaluate the acute effects of oral nicotine pouch (ONP) use on subjective cigarette craving and prefrontal neural responses to smoking-related cues among adult cigarette smokers. Although oral nicotine pouches do not involve combustion or inhalation, their effects on craving relief and neural cue reactivity following nicotine abstinence remain poorly understood. Characterizing these acute responses may improve understanding of the potential role of oral nicotine pouches as lower-risk nicotine products.
This is a single-arm, within-subject, repeated-measures study consisting of one baseline screening visit and one experimental visit. During the baseline visit, informed consent will be obtained, eligibility will be confirmed, demographic and tobacco use information will be collected, nicotine dependence will be assessed, and head circumference will be measured to determine appropriate functional near-infrared spectroscopy (fNIRS) cap sizing. Participants will also receive instructions to abstain from nicotine use for at least 12 hours before the experimental visit.
At the experimental visit, overnight nicotine abstinence will be verified before participants complete baseline assessments of subjective craving and nicotine withdrawal. Participants will then complete a standardized smoking cue reactivity task while prefrontal brain activity is recorded using functional near-infrared spectroscopy (fNIRS). Following completion of the baseline task, participants will self-administer one commercially available 6 mg oral nicotine pouch and complete a standardized 25-minute absorption period. Participants will then complete an identical post-pouch cue reactivity task with simultaneous fNIRS recording, followed by post-session assessments of craving, withdrawal, subjective product effects, and product perceptions.
The smoking cue reactivity task consists of repeated presentations of smoking-related and neutral visual cues, followed by guided imagery in which participants imagine smoking a cigarette or performing a comparable neutral behavior while holding the corresponding object. The task is administered before and after nicotine pouch administration using identical procedures to permit within-subject comparisons of neural and subjective responses.
Functional near-infrared spectroscopy is a non-invasive neuroimaging technique that measures changes in oxygenated and deoxygenated hemoglobin within cortical tissue as an indirect measure of neural activity. Brain activity will be recorded continuously throughout both cue reactivity task runs using a standardized prefrontal optode montage. Participants will be monitored throughout study procedures for discomfort, and study procedures will be discontinued if requested by the participant or if study staff determine continuation is not appropriate.
- Conditions
- Nicotine Dependence
- Being tested
- Oral Nicotine Pouch, Smoking Cue Reactivity Task
- Keywords
- Oral Nicotine Pouches, Oral Nicotine Products, Smoking, Cigarettes, Harm Reduction
- Medical subject headings
- Tobacco Use Disorder, Smoking, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nicotine PouchOther
Participants will self-administer one commercially available 6 mg oral nicotine pouch following overnight nicotine abstinence. The pouch will be used for approximately 25 minutes before participants complete the post-pouch cue reactivity assessment.
Smoking Cue Reactivity TaskBehavioural
Participants will complete a standardized smoking cue reactivity task before and after oral nicotine pouch administration. During each task, participants will view smoking-related and neutral images, complete guided imagination trials while holding either a cigarette or a neutral object, and undergo simultaneous functional near-infrared spectroscopy (fNIRS) to measure prefrontal brain activity.
| Study group | Role | What they receive |
|---|---|---|
| Acute Oral Nicotine Pouch Administration | Experimental | Adult cigarette smokers will complete one experimental session consisting of pre-pouch cue reactivity and subjective assessments, administration of a single 6 mg oral nicotine pouch, a standardized 25-minute absorption period, and identical post-pouch assessments. All participants complete the same study procedures and serve as their own control for pre- versus post-intervention comparisons. Receives: Other: Oral Nicotine Pouch; Behavioral: Smoking Cue Reactivity Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prefrontal Neural Cue Reactivity to Smoking-Related Cues Measured by Functional Near-Infrared Spectroscopy (fNIRS)
Prefrontal neural responses to smoking-related and neutral cues will be assessed using functional near-infrared spectroscopy (fNIRS). The primary outcome will be the within-subject change in oxygenated (HbO) and deoxygenated (HbR) hemoglobin concentration from the pre-pouch assessment to the post-pouch assessment. Larger positive HbO responses to smoking-related cues indicate greater neural cue reactivity.
Measured: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.
Change in Subjective Cigarette Craving Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)
Subjective cigarette craving will be assessed using the Questionnaire of Smoking Urges-Brief (QSU-Brief). The QSU-Brief consists of 10 items, each rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Total scores range from 10 to 70, with higher scores indicating greater cigarette craving (worse outcome). The primary outcome will be the within-subject change in total QSU-Brief score from the pre-pouch assessment to the post-pouch assessment.
Measured: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start30 Apr 2026
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Robert Monterosso, University of Southern California
- Investigators
- Natalia Peraza, Principal investigator, University of Southern CaliforniaJohn Monterosso, Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698470
- Sponsor's protocol ID
- UP-25-00525
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in any future publications (e.g., self-reported craving scores, task performance metrics, and fNIRS-derived signal outputs) will be shared. The data will be stripped of all personally identifying information in accordance with HIPAA guidelines and made available upon reasonable request for academic and research purposes. A data dictionary and codebook will be provided to facilitate reuse. Access will be granted upon request to the corresponding author.
Publications
Sofuoglu M, Herman AI, Nadim H, Jatlow P. Rapid nicotine clearance is associated with greater reward and heart rate increases from intravenous nicotine. Neuropsychopharmacology. 2012 May;37(6):1509-16. doi: 10.1038/npp.2011.336. Epub 2012 Feb 15.
PubMed 22334123Leventhal AM, Waters AJ, Boyd S, Moolchan ET, Lerman C, Pickworth WB. Gender differences in acute tobacco withdrawal: effects on subjective, cognitive, and physiological measures. Exp Clin Psychopharmacol. 2007 Feb;15(1):21-36. doi: 10.1037/1064-1297.15.1.21.
PubMed 17295582Leventhal A, Cho J, Barrington-Trimis J, Pang R, Schiff S, Kirkpatrick M. Sensory attributes of e-cigarette flavours and nicotine as mediators of interproduct differences in appeal among young adults. Tob Control. 2020 Nov;29(6):679-686. doi: 10.1136/tobaccocontrol-2019-055172. Epub 2019 Dec 18.
PubMed 31852818Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry. 1986 Mar;43(3):289-94. doi: 10.1001/archpsyc.1986.01800030107013.
PubMed 3954551Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
PubMed 1932883Rest EC, Brikmanis KN, Mermelstein RJ. Preferred flavors and tobacco use patterns in adult dual users of cigarettes and ENDS. Addict Behav. 2022 Feb;125:107168. doi: 10.1016/j.addbeh.2021.107168. Epub 2021 Oct 30.
PubMed 34772504Pang RD, Goldenson NI, Kirkpatrick M, Barrington-Trimis JL, Cho J, Leventhal AM. Sex differences in the appeal of flavored e-cigarettes among young adult e-cigarette users. Psychol Addict Behav. 2020 Mar;34(2):303-307. doi: 10.1037/adb0000548. Epub 2020 Jan 20.
PubMed 31961168Kroczek AM, Haeussinger FB, Fallgatter AJ, Batra A, Ehlis AC. Prefrontal functional connectivity measured with near-infrared spectroscopy during smoking cue exposure. Addict Biol. 2017 Mar;22(2):513-522. doi: 10.1111/adb.12344. Epub 2015 Dec 21.
PubMed 26687485Shiffman S, Dunbar M, Kirchner T, Li X, Tindle H, Anderson S, Scholl S. Smoker reactivity to cues: effects on craving and on smoking behavior. J Abnorm Psychol. 2013 Feb;122(1):264-80. doi: 10.1037/a0028339. Epub 2012 Jun 18.
PubMed 22708884Keijsers M, Vega-Corredor MC, Hoermann S, Tomintz M. Cue Reactivity to Electronic Cigarettes: A Systematic Review. Subst Abuse. 2022 Jul 28;16:11782218221114971. doi: 10.1177/11782218221114971. eCollection 2022.
PubMed 35923180Goldstein RZ, Volkow ND. Drug addiction and its underlying neurobiological basis: neuroimaging evidence for the involvement of the frontal cortex. Am J Psychiatry. 2002 Oct;159(10):1642-52. doi: 10.1176/appi.ajp.159.10.1642.
PubMed 12359667Ekhtiari H, Nasseri P, Yavari F, Mokri A, Monterosso J. Neuroscience of drug craving for addiction medicine: From circuits to therapies. Prog Brain Res. 2016;223:115-41. doi: 10.1016/bs.pbr.2015.10.002. Epub 2015 Dec 19.
PubMed 26806774Killen JD, Fortmann SP. Craving is associated with smoking relapse: findings from three prospective studies. Exp Clin Psychopharmacol. 1997 May;5(2):137-42. doi: 10.1037//1064-1297.5.2.137.
PubMed 9234050FDA. FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review. Accessed May 14, 2025. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-20-zyn-nicotine-pouch-products-after-extensive-scientific-review
Azzopardi D, Liu C, Murphy J. Chemical characterization of tobacco-free "modern" oral nicotine pouches and their position on the toxicant and risk continuums. Drug Chem Toxicol. 2022 Sep;45(5):2246-2254. doi: 10.1080/01480545.2021.1925691. Epub 2021 May 25.
PubMed 34034614
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cue-Exposure Response Evaluation: Brain Reactivity to ONPs
- ClinicalTrials.gov ID
- NCT07698470
- Acronym / sponsor ID
- UP-25-00525
- Conditions
- Nicotine Dependence
- Keywords
- Oral Nicotine Pouches, Oral Nicotine Products, Smoking, Cigarettes, Harm Reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Jul 2026 (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.
Oral nicotine pouches (ONPs) are non-combustible nicotine products that may reduce cigarette craving and smoking cue-induced brain activity, supporting their potential as harm-reduction tools for adults who smoke cigarettes. This within-subject, repeated-measures study will evaluate the acute effects of a single 6 mg oral nicotine pouch on subjective craving and prefrontal neural responses to smoking-related cues using functional near-infrared spectroscopy (fNIRS). Participants will complete assessments before and after nicotine pouch administration following overnight nicotine abstinence to characterize changes in craving and neural cue reactivity.
Detailed description
This study will evaluate the acute effects of oral nicotine pouch (ONP) use on subjective cigarette craving and prefrontal neural responses to smoking-related cues among adult cigarette smokers. Although oral nicotine pouches do not involve combustion or inhalation, their effects on craving relief and neural cue reactivity following nicotine abstinence remain poorly understood. Characterizing these acute responses may improve understanding of the potential role of oral nicotine pouches as lower-risk nicotine products.
This is a single-arm, within-subject, repeated-measures study consisting of one baseline screening visit and one experimental visit. During the baseline visit, informed consent will be obtained, eligibility will be confirmed, demographic and tobacco use information will be collected, nicotine dependence will be assessed, and head circumference will be measured to determine appropriate functional near-infrared spectroscopy (fNIRS) cap sizing. Participants will also receive instructions to abstain from nicotine use for at least 12 hours before the experimental visit.
At the experimental visit, overnight nicotine abstinence will be verified before participants complete baseline assessments of subjective craving and nicotine withdrawal. Participants will then complete a standardized smoking cue reactivity task while prefrontal brain activity is recorded using functional near-infrared spectroscopy (fNIRS). Following completion of the baseline task, participants will self-administer one commercially available 6 mg oral nicotine pouch and complete a standardized 25-minute absorption period. Participants will then complete an identical post-pouch cue reactivity task with simultaneous fNIRS recording, followed by post-session assessments of craving, withdrawal, subjective product effects, and product perceptions.
The smoking cue reactivity task consists of repeated presentations of smoking-related and neutral visual cues, followed by guided imagery in which participants imagine smoking a cigarette or performing a comparable neutral behavior while holding the corresponding object. The task is administered before and after nicotine pouch administration using identical procedures to permit within-subject comparisons of neural and subjective responses.
Functional near-infrared spectroscopy is a non-invasive neuroimaging technique that measures changes in oxygenated and deoxygenated hemoglobin within cortical tissue as an indirect measure of neural activity. Brain activity will be recorded continuously throughout both cue reactivity task runs using a standardized prefrontal optode montage. Participants will be monitored throughout study procedures for discomfort, and study procedures will be discontinued if requested by the participant or if study staff determine continuation is not appropriate.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Oral Nicotine Pouch Administration | Experimental | Other: Oral Nicotine Pouch, Behavioral: Smoking Cue Reactivity TaskAdult cigarette smokers will complete one experimental session consisting of pre-pouch cue reactivity and subjective assessments, administration of a single 6 mg oral nicotine pouch, a standardized 25-minute absorption period, and identical post-pouch assessments. All participants complete the same study procedures and serve as their own control for pre- versus post-intervention comparisons. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 21 years - 55 years
- Self-reported use of cigarettes within the past 30 days
- Biochemical confirmation of cigarette use:
- o Carbon monoxide (CO) breath sample ≥10 ppm
- Fagerström Test for Nicotine Dependence (FTND) score ≥5, indicating moderate to high nicotine dependence
Key exclusion criteria (7 listed)
- Age younger than 21 years or older than 55 years
- Biochemical evidence inconsistent with recent cigarette use:
- o CO breath sample <10 ppm
- Expressed intent to reduce or quit nicotine use within the next 30 days
- History of medical conditions contraindicated for nicotine use (e.g., uncontrolled hypertension, recent cardiac events)
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 |
|---|---|---|
| Oral Nicotine PouchParticipants will self-administer one commercially available 6 mg oral nicotine pouch following overnight nicotine abstinence. The pouch will be used for approximately 25 minutes before participants complete the post-pouch cue reactivity assessment. | Other | Acute Oral Nicotine Pouch Administration |
| Smoking Cue Reactivity TaskParticipants will complete a standardized smoking cue reactivity task before and after oral nicotine pouch administration. During each task, participants will view smoking-related and neutral images, complete guided imagination trials while holding either a cigarette or a neutral object, and undergo simultaneous functional near-infrared spectroscopy (fNIRS) to measure prefrontal brain activity. | Behavioural | Acute Oral Nicotine Pouch Administration |
Primary outcome
Change in Prefrontal Neural Cue Reactivity to Smoking-Related Cues Measured by Functional Near-Infrared Spectroscopy (fNIRS)
Time frame: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.
Prefrontal neural responses to smoking-related and neutral cues will be assessed using functional near-infrared spectroscopy (fNIRS). The primary outcome will be the within-subject change in oxygenated (HbO) and deoxygenated (HbR) hemoglobin concentration from the pre-pouch assessment to the post-pouch assessment. Larger positive HbO responses to smoking-related cues indicate greater neural cue reactivity.
Change in Subjective Cigarette Craving Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)
Time frame: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.
Subjective cigarette craving will be assessed using the Questionnaire of Smoking Urges-Brief (QSU-Brief). The QSU-Brief consists of 10 items, each rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Total scores range from 10 to 70, with higher scores indicating greater cigarette craving (worse outcome). The primary outcome will be the within-subject change in total QSU-Brief score from the pre-pouch assessment to the post-pouch assessment.
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 13 Jul 2026.
- Background: PubMed 22334123Sofuoglu M, Herman AI, Nadim H, Jatlow P. Rapid nicotine clearance is associated with greater reward and heart rate increases from intravenous nicotine. Neuropsychopharmacology. 2012 May;37(6):1509-16. doi: 10.1038/npp.2011.336. Epub 2012 Feb 15.
- Background: PubMed 17295582Leventhal AM, Waters AJ, Boyd S, Moolchan ET, Lerman C, Pickworth WB. Gender differences in acute tobacco withdrawal: effects on subjective, cognitive, and physiological measures. Exp Clin Psychopharmacol. 2007 Feb;15(1):21-36. doi: 10.1037/1064-1297.15.1.21.
- Background: PubMed 31852818Leventhal A, Cho J, Barrington-Trimis J, Pang R, Schiff S, Kirkpatrick M. Sensory attributes of e-cigarette flavours and nicotine as mediators of interproduct differences in appeal among young adults. Tob Control. 2020 Nov;29(6):679-686. doi: 10.1136/tobaccocontrol-2019-055172. Epub 2019 Dec 18.
- Background: PubMed 3954551Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry. 1986 Mar;43(3):289-94. doi: 10.1001/archpsyc.1986.01800030107013.
- Background: PubMed 1932883Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
- Background: PubMed 34772504Rest EC, Brikmanis KN, Mermelstein RJ. Preferred flavors and tobacco use patterns in adult dual users of cigarettes and ENDS. Addict Behav. 2022 Feb;125:107168. doi: 10.1016/j.addbeh.2021.107168. Epub 2021 Oct 30.
- Background: PubMed 31961168Pang RD, Goldenson NI, Kirkpatrick M, Barrington-Trimis JL, Cho J, Leventhal AM. Sex differences in the appeal of flavored e-cigarettes among young adult e-cigarette users. Psychol Addict Behav. 2020 Mar;34(2):303-307. doi: 10.1037/adb0000548. Epub 2020 Jan 20.
- Background: PubMed 26687485Kroczek AM, Haeussinger FB, Fallgatter AJ, Batra A, Ehlis AC. Prefrontal functional connectivity measured with near-infrared spectroscopy during smoking cue exposure. Addict Biol. 2017 Mar;22(2):513-522. doi: 10.1111/adb.12344. Epub 2015 Dec 21.
- Background: PubMed 22708884Shiffman S, Dunbar M, Kirchner T, Li X, Tindle H, Anderson S, Scholl S. Smoker reactivity to cues: effects on craving and on smoking behavior. J Abnorm Psychol. 2013 Feb;122(1):264-80. doi: 10.1037/a0028339. Epub 2012 Jun 18.
- Background: PubMed 35923180Keijsers M, Vega-Corredor MC, Hoermann S, Tomintz M. Cue Reactivity to Electronic Cigarettes: A Systematic Review. Subst Abuse. 2022 Jul 28;16:11782218221114971. doi: 10.1177/11782218221114971. eCollection 2022.
- Background: PubMed 12359667Goldstein RZ, Volkow ND. Drug addiction and its underlying neurobiological basis: neuroimaging evidence for the involvement of the frontal cortex. Am J Psychiatry. 2002 Oct;159(10):1642-52. doi: 10.1176/appi.ajp.159.10.1642.
- Background: PubMed 26806774Ekhtiari H, Nasseri P, Yavari F, Mokri A, Monterosso J. Neuroscience of drug craving for addiction medicine: From circuits to therapies. Prog Brain Res. 2016;223:115-41. doi: 10.1016/bs.pbr.2015.10.002. Epub 2015 Dec 19.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in any future publications (e.g., self-reported craving scores, task performance metrics, and fNIRS-derived signal outputs) will be shared. The data will be stripped of all personally identifying information in accordance with HIPAA guidelines and made available upon reasonable request for academic and research purposes. A data dictionary and codebook will be provided to facilitate reuse. Access will be granted upon request to the corresponding author.
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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.
Natalia Peraza principal investigator
University of Southern California
John Monterosso study chair
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nicotine Pouch and Smoking Cue Reactivity Task in people with Nicotine Dependence, run by University of Southern California 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 8 inclusion and 7 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 13 Jul 2026. 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. 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 USC Nicotine and Tobacco Studies (213-821-0807, USCONPStudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prefrontal Neural Cue Reactivity to Smoking-Related Cues Measured by Functional Near-Infrared Spectroscopy (fNIRS) (time frame: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental 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 NCT07698470, which also lists 18 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 13 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.