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This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3mg Nicotine Concentration | Experimental | 15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration. |
|
| 6mg Nicotine Concentration | Experimental | 15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZYN | Device | 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cigarettes Smoked Per Day (Log-transformed) | The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview. | up to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Switched From Cigarettes to the ZYN Pouches. | To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations | This will be evaluated at week 4. |
| Percentage of Smoke Free Days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24951496 | Background | Berg CJ, Haardoerfer R, Escoffery C, Zheng P, Kegler M. Cigarette users' interest in using or switching to electronic nicotine delivery systems for smokeless tobacco for harm reduction, cessation, or novelty: a cross-sectional survey of US adults. Nicotine Tob Res. 2015 Feb;17(2):245-55. doi: 10.1093/ntr/ntu103. Epub 2014 Jun 20. | |
| 24249254 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3mg Nicotine Concentration | 15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration. ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts. |
| FG001 | 6mg Nicotine Concentration | 15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration. ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3mg Nicotine Concentration | 15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration. ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Cigarettes Smoked Per Day (Log-transformed) | The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview. | Posted | Mean | Standard Deviation | number of cigarettes smoked | up to week 4 |
|
Up to 4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3mg Nicotine Concentration | 15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration. ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chest pain | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Fucito, PhD: Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry | Yale School of Medicine | (203) 688-1878 | lisa.fucito@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2023 | Aug 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D040261 | Harm Reduction |
| D063646 | Carcinogenesis |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.
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The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations
| up to week 4 |
| Level of Biomarker (NNAL) Among Smokers | Participants will provide repeated lab samples for biomarker assessments. Urine samples obtained will be compared at baseline and week 4 for differences by group and by time. | baseline and week 4 |
| Subjective Effects of Oral Nicotine Pouches | To evaluate the acceptability of switching, participants will also be asked how likely it is that they will continue to use ZYN oral nicotine patches for cigarette substitution compared to cigarettes on a question designed for this trial. | week 4 |
| Brawley OW, Glynn TJ, Khuri FR, Wender RC, Seffrin JR. The first Surgeon General's report on smoking and health: the 50th anniversary. CA Cancer J Clin. 2014 Jan-Feb;64(1):5-8. doi: 10.3322/caac.21210. Epub 2013 Nov 18. No abstract available. |
| 24962838 | Background | Brenner DR, Scherer D, Muir K, Schildkraut J, Boffetta P, Spitz MR, Le Marchand L, Chan AT, Goode EL, Ulrich CM, Hung RJ. A review of the application of inflammatory biomarkers in epidemiologic cancer research. Cancer Epidemiol Biomarkers Prev. 2014 Sep;23(9):1729-51. doi: 10.1158/1055-9965.EPI-14-0064. Epub 2014 Jun 24. |
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| 26939927 | Background | Cella D, Lai JS, Jensen SE, Christodoulou C, Junghaenel DU, Reeve BB, Stone AA. PROMIS Fatigue Item Bank had Clinical Validity across Diverse Chronic Conditions. J Clin Epidemiol. 2016 May;73:128-34. doi: 10.1016/j.jclinepi.2015.08.037. Epub 2016 Mar 3. |
| 28151705 | Background | Chang CM, Edwards SH, Arab A, Del Valle-Pinero AY, Yang L, Hatsukami DK. Biomarkers of Tobacco Exposure: Summary of an FDA-Sponsored Public Workshop. Cancer Epidemiol Biomarkers Prev. 2017 Mar;26(3):291-302. doi: 10.1158/1055-9965.EPI-16-0675. Epub 2016 Nov 9. |
| 29346338 | Background | Jamal A, Phillips E, Gentzke AS, Homa DM, Babb SD, King BA, Neff LJ. Current Cigarette Smoking Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Jan 19;67(2):53-59. doi: 10.15585/mmwr.mm6702a1. |
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| 28092948 | Background | Hecht SS. Oral Cell DNA Adducts as Potential Biomarkers for Lung Cancer Susceptibility in Cigarette Smokers. Chem Res Toxicol. 2017 Jan 17;30(1):367-375. doi: 10.1021/acs.chemrestox.6b00372. Epub 2016 Dec 1. |
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| 25307510 | Background | Irwin DE, Atwood CA Jr, Hays RD, Spritzer K, Liu H, Donohue JF, Leidy NK, Yount SE, DeWalt DA. Correlation of PROMIS scales and clinical measures among chronic obstructive pulmonary disease patients with and without exacerbations. Qual Life Res. 2015 Apr;24(4):999-1009. doi: 10.1007/s11136-014-0818-1. Epub 2014 Oct 12. |
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| 29301008 | Background | Morean ME, Krishnan-Sarin S, Sussman S, Foulds J, Fishbein H, Grana R, O'Malley SS. Psychometric Evaluation of the E-cigarette Dependence Scale. Nicotine Tob Res. 2019 Oct 26;21(11):1556-1564. doi: 10.1093/ntr/ntx271. |
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| Background | Sobell, L., & Sobell, M. (1995). Alcohol consumption measures. In J. Allen & M. Columbus (Eds.), Assessing alcohol problems: A guide for clinicians and researcher (pp. 55-73). Bethesda, MD: National Institute on Alcohol Abuse & Alcoholism. |
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| 28860576 | Background | Zhang M, Li G, Wang Y, Wang Y, Zhao S, Haihong P, Zhao H, Wang Y. PD-L1 expression in lung cancer and its correlation with driver mutations: a meta-analysis. Sci Rep. 2017 Aug 31;7(1):10255. doi: 10.1038/s41598-017-10925-7. |
| 40550628 | Derived | Fucito LM, Baldassarri SR, Wu R, Gueorguieva R, Morean ME, Herbst RS, Krishnan-Sarin S, O'Malley SS. Effects of oral nicotine pouches on cigarette smoking behaviour and tobacco harm exposure: a randomised pilot trial in adults. Tob Control. 2025 Jun 23:tc-2024-059094. doi: 10.1136/tc-2024-059094. Online ahead of print. |
| 6mg Nicotine Concentration |
15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration. ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoke within 30 minutes of waking | This is binary count of yes/no responses to whether or not participants smoke their first cigarette within 30 minutes of waking in the morning. | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants Who Switched From Cigarettes to the ZYN Pouches. | To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations | Posted | Count of Participants | Participants | This will be evaluated at week 4. |
|
|
|
| Secondary | Percentage of Smoke Free Days. | The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations | Posted | Mean | Standard Deviation | percentage of smoke free days | up to week 4 |
|
|
|
|
| Secondary | Level of Biomarker (NNAL) Among Smokers | Participants will provide repeated lab samples for biomarker assessments. Urine samples obtained will be compared at baseline and week 4 for differences by group and by time. | Posted | Least Squares Mean | Standard Error | pg/mL | baseline and week 4 |
|
|
|
| Secondary | Subjective Effects of Oral Nicotine Pouches | To evaluate the acceptability of switching, participants will also be asked how likely it is that they will continue to use ZYN oral nicotine patches for cigarette substitution compared to cigarettes on a question designed for this trial. | This measure was not used in the study and therefore data were not collected. | Posted | week 4 |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 13 |
| 15 |
| EG001 | 6mg Nicotine Concentration | 15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration. ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts. | 0 | 15 | 0 | 15 | 13 | 15 |
| rapid heartbeat | Cardiac disorders | Systematic Assessment |
|
| vision problems | Eye disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| appetite changes | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| fever | General disorders | Systematic Assessment |
|
| other | General disorders | Systematic Assessment |
|
| sore throat | Infections and infestations | Systematic Assessment |
|
| weight loss | Investigations | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| fainting | Nervous system disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| vivid dreams | Psychiatric disorders | Systematic Assessment |
|
| difficulty sleeping | Psychiatric disorders | Systematic Assessment |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| itching or rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| sweating | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D009385 |
| Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |