Tobacco Use DisorderZYNNCT04250727

Switching to Potential Reduced Exposure Products in Adult Smokers

A study testing ZYN in people with Tobacco Use Disorder and Oral Nicotine Pouch Use, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 to 77 years
Conditions the study is for: Tobacco Use Disorder, Oral Nicotine Pouch Use, Smoking Behaviors
What is being tested?: ZYN
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 1 May 2021to 17 Aug 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 21 to 77 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

21-77 years old(in line with NIH guidelines for 18+ being the age of consent in adults) (2008 PHS Guideline Update Panel)
English literate
Smoke at least 1 cigarette per day
Expired breath carbon monoxide level ≥ 6ppm at baseline
Not currently actively pursuing smoking cessation services or planning to use evidence-based cessation tools to quit in the next month
Not interested in the use of existing FDA-approved tobacco pharmacotherapies (i.e., NRT, wellbutrin, varenicline).

Who cannot join

Currently using any stop smoking treatments (2008 PHS Guideline Update Panel)
History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia)
Current uncontrolled medical condition
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)
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
Severe lung disease that requires supplemental oxygen

Show all 11Show fewer

Uncontrolled asthma (<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year)
Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year)
Planning to quit smoking with a set goal or time for quit attempt
Known hypersensitivity to propylene glycol
Patients with an FEV1 < 40%

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University
New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: Switching to a Non-tobacco-based Oral Nicotine Product Among Adult Cigarette Smokers: Exploring the Roles of Product Characteristics and User History

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.

Conditions: Tobacco Use Disorder, Oral Nicotine Pouch Use, Smoking Behaviors, Harm Reduction, Toxic Effect of Tobacco and Nicotine, Carcinogenesis
Being tested: ZYN
Medical subject headings: Tobacco Use Disorder, Smoking, Harm Reduction, Carcinogenesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZYNDevice
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.

Study groups in NCT04250727
Study group	Role	What they receive
3mg Nicotine Concentration	Experimental	15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration. Receives: Device: ZYN
6mg Nicotine Concentration	Experimental	15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration. Receives: Device: ZYN

What is being measured

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

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.
Measured: up to week 4

Secondary outcomes (4)

Number of Participants Who Switched From Cigarettes to the ZYN Pouches.
To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations
Measured: This will be evaluated at week 4.
Percentage of Smoke Free Days.
The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations
Measured: 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.
Measured: 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.
Measured: week 4

Timeline

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

1 May 202117 Aug 2022

First posted31 Jan 2020
Study start1 May 2021
Primary completion17 Aug 2022
Study completion17 Aug 2022

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 (29)Papers the sponsor has linked to this study.
Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: 30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04250727
Sponsor's protocol ID: 2000023826
Acronym: ZYN
Status last verified: Apr 2024
First submitted: 17 Jan 2020
Last updated: 1 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 24951496
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.
PubMed 24249254
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.
PubMed 24962838
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.
PubMed 16875787
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.
PubMed 26939927
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.
PubMed 28151705
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.
PubMed 29346338
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.
PubMed 11260806
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.
PubMed 26525063
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.
PubMed 15824536
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.
PubMed 26135334
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.
PubMed 1932883
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.
PubMed 28092948
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.
PubMed 21411244
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.
PubMed 3954551

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 Tobacco Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Switching to a Non-tobacco-based Oral Nicotine Product Among Adult Cigarette Smokers: Exploring the Roles of Product Characteristics and User History
ClinicalTrials.gov ID: NCT04250727
Acronym / sponsor ID: ZYN / 2000023826
Conditions: Tobacco Use Disorder, Oral Nicotine Pouch Use, Smoking Behaviors, Harm Reduction, Toxic Effect of Tobacco and Nicotine, Carcinogenesis
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Study start: 1 May 2021 (actual)
Primary completion: 17 Aug 2022 (actual)
Study completion: 17 Aug 2022 (actual)
First posted: 31 Jan 2020 (actual)
Results: Posted 26 Mar 2024

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: 30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.

Arm	Type	Receives
3mg Nicotine Concentration	Experimental	Device: ZYN15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.
6mg Nicotine Concentration	Experimental	Device: ZYN15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.

Who may qualify

Ages: 21 to 77 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

21-77 years old(in line with NIH guidelines for 18+ being the age of consent in adults) (2008 PHS Guideline Update Panel)
English literate
Smoke at least 1 cigarette per day
Expired breath carbon monoxide level ≥ 6ppm at baseline
Not currently actively pursuing smoking cessation services or planning to use evidence-based cessation tools to quit in the next month

Key exclusion criteria (11 listed)

Currently using any stop smoking treatments (2008 PHS Guideline Update Panel)
History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia)
Current uncontrolled medical condition
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)
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

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
ZYN30 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.	Device	3mg Nicotine Concentration, 6mg Nicotine Concentration

Primary outcome

Number of Cigarettes Smoked Per Day (Log-transformed)
Time frame: up to week 4
The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.

4 secondary outcomes

Number of Participants Who Switched From Cigarettes to the ZYN Pouches.
Time frame: This will be evaluated at week 4.
Percentage of Smoke Free Days.
Time frame: up to week 4
Level of Biomarker (NNAL) Among Smokers
Time frame: baseline and week 4
Subjective Effects of Oral Nicotine Pouches
Time frame: week 4

Results and safety

Results posted to the registry on 26 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3mg Nicotine Concentration	15	15
6mg Nicotine Concentration	15	15

Primary outcome: Number of Cigarettes Smoked Per Day (Log-transformed)

Time frame: up to week 4. Mean (Standard Deviation). Unit: number of cigarettes smoked

Measure	3mg Nicotine Concentration n = 15	6mg Nicotine Concentration n = 15
Value	2.0 (0.1)	1.8 (0.1)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3mg Nicotine Concentration	0 of 15 (0%)	13 of 15 (86.7%)	0 of 15
6mg Nicotine Concentration	0 of 15 (0%)	13 of 15 (86.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24951496Berg 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.
Background: PubMed 24249254Brawley 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.
Background: PubMed 24962838Brenner 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.
Background: PubMed 16875787Cappelleri 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.
Background: PubMed 26939927Cella 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.
Background: PubMed 28151705Chang 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.
Background: PubMed 29346338Jamal 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.
Background: PubMed 11260806Cox 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.
Background: PubMed 26525063Delnevo 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.
Background: PubMed 15824536Fagerstrom 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.
Background: PubMed 26135334Grace 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.
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.
Individual participant dataSharing planned: No

Related trials for Tobacco Use Disorder

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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 ZYN in people with Tobacco Use Disorder and Oral Nicotine Pouch Use, run by Yale 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 1 May 2024. 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?

Yes. Results are posted in the registry (first posted 26 Mar 2024). 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?

Number of Cigarettes Smoked Per Day (Log-transformed) (time frame: up to week 4). 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 NCT04250727, which also lists 29 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 1 May 2024.