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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04250727
Other study ID # 2000023826
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date August 17, 2022

Study information

Verified date April 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 17, 2022
Est. primary completion date August 17, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years to 77 Years
Eligibility Inclusion Criteria: 1. 21-77 years old(in line with NIH guidelines for 18+ being the age of consent in adults) (2008 PHS Guideline Update Panel) 2. English literate 3. Smoke at least 1 cigarette per day 4. Expired breath carbon monoxide level = 6ppm at baseline 5. Not currently actively pursuing smoking cessation services or planning to use evidence-based cessation tools to quit in the next month 6. Not interested in the use of existing FDA-approved tobacco pharmacotherapies (i.e., NRT, wellbutrin, varenicline). Exclusion Criteria: 1. Currently using any stop smoking treatments (2008 PHS Guideline Update Panel) 2. History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia) 3. Current uncontrolled medical condition 4. Cardiac conditions that required a hospitalization or intensive treatment on an outpatient basis in the past year including: myocardial infarction, coronary artery disease, unstable angina, congestive heart failure, or tachyarrhythmias (including rapid atrial fibrillation, ventricular tachycardia, or ventricular fibrillation) 5. Female participants of child-bearing age will be excluded if they are currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms) for the duration of the study 6. Severe lung disease that requires supplemental oxygen 7. Uncontrolled asthma (<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year) 8. Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year) 9. Planning to quit smoking with a set goal or time for quit attempt 10. Known hypersensitivity to propylene glycol 11. Patients with an FEV1 < 40%

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
United States Yale University New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (28)

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. — View Citation

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. — View Citation

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. — View Citation

Cappelleri JC, Bushmakin AG, Baker CL, Merikle E, Olufade AO, Gilbert DG. Confirmatory factor analyses and reliability of the modified cigarette evaluation questionnaire. Addict Behav. 2007 May;32(5):912-23. doi: 10.1016/j.addbeh.2006.06.028. Epub 2006 Jul 27. — View Citation

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. — View Citation

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. — View Citation

Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. doi: 10.1080/14622200020032051. — View Citation

Delnevo CD, Giovenco DP, Steinberg MB, Villanti AC, Pearson JL, Niaura RS, Abrams DB. Patterns of Electronic Cigarette Use Among Adults in the United States. Nicotine Tob Res. 2016 May;18(5):715-9. doi: 10.1093/ntr/ntv237. Epub 2015 Nov 2. — View Citation

Fagerstrom KO. Can reduced smoking be a way for smokers not interested in quitting to actually quit? Respiration. 2005 Mar-Apr;72(2):216-20. doi: 10.1159/000084057. — View Citation

Grace RC, Kivell BM, Laugesen M. Gender differences in satisfaction ratings for nicotine electronic cigarettes by first-time users. Addict Behav. 2015 Nov;50:140-3. doi: 10.1016/j.addbeh.2015.06.027. Epub 2015 Jun 12. — View Citation

Heatherton 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. — View Citation

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. — View Citation

Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry. 1986 Mar;43(3):289-94. doi: 10.1001/archpsyc.1986.01800030107013. — View Citation

Hughes JR. The hardening hypothesis: is the ability to quit decreasing due to increasing nicotine dependence? A review and commentary. Drug Alcohol Depend. 2011 Sep 1;117(2-3):111-7. doi: 10.1016/j.drugalcdep.2011.02.009. Epub 2011 Mar 15. — View Citation

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. — View Citation

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. — View Citation

King BA, Patel R, Nguyen KH, Dube SR. Trends in awareness and use of electronic cigarettes among US adults, 2010-2013. Nicotine Tob Res. 2015 Feb;17(2):219-27. doi: 10.1093/ntr/ntu191. Epub 2014 Sep 19. — View Citation

Le Houezec J. Role of nicotine pharmacokinetics in nicotine addiction and nicotine replacement therapy: a review. Int J Tuberc Lung Dis. 2003 Sep;7(9):811-9. — View Citation

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. Erratum In: Nicotine Tob Res. 2020 Oct 29;22(11):2123. — View Citation

Patel D, Davis KC, Cox S, Bradfield B, King BA, Shafer P, Caraballo R, Bunnell R. Reasons for current E-cigarette use among U.S. adults. Prev Med. 2016 Dec;93:14-20. doi: 10.1016/j.ypmed.2016.09.011. Epub 2016 Sep 7. — View Citation

Peng Y, Croce CM. The role of MicroRNAs in human cancer. Signal Transduct Target Ther. 2016 Jan 28;1:15004. doi: 10.1038/sigtrans.2015.4. eCollection 2016. — View Citation

Popova L, Ling PM. Alternative tobacco product use and smoking cessation: a national study. Am J Public Health. 2013 May;103(5):923-30. doi: 10.2105/AJPH.2012.301070. Epub 2013 Mar 14. — View Citation

Rose M, Bjorner JB, Gandek B, Bruce B, Fries JF, Ware JE Jr. The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. J Clin Epidemiol. 2014 May;67(5):516-26. doi: 10.1016/j.jclinepi.2013.10.024. — View Citation

Shadel WG, Edelen MO, Tucker JS, Stucky BD, Hansen M, Cai L. Development of the PROMIS nicotine dependence item banks. Nicotine Tob Res. 2014 Sep;16 Suppl 3(Suppl 3):S190-201. doi: 10.1093/ntr/ntu032. — View Citation

Shahab L, Goniewicz ML, Blount BC, Brown J, McNeill A, Alwis KU, Feng J, Wang L, West R. Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users: A Cross-sectional Study. Ann Intern Med. 2017 Mar 21;166(6):390-400. doi: 10.7326/M16-1107. Epub 2017 Feb 7. — View Citation

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.

Sobell, L., & Sobell, M. (2003). Alcohol consumption measures. In J. P. A. a. V. B. & Wilson (Eds.), Assessing alcohol problems: A guide for clinicians and researchers. (pp. 75-99). Bethesda, MD: National Institute on Alcohol Abuse & Alcoholism.

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. — View Citation

* Note: There are 28 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
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. up to week 4
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 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 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. 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. week 4
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