Smoking BehaviorsIQOSNCT04861428
Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine (IQOS)
A study testing IQOS and Smoking as Usual in people with Smoking Behaviors, run by University of Pittsburgh at 1 site in United States.
Trial summary
A novel heat-not-burn tobacco product (IQOS) will be provided to smokers, compared against a (cigarette) smoking as usual period in counter-balanced order in a cross-over design. Read more about this study
- Who is it for?
- Ages 21 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Behaviors
- What is being tested?
- IQOS and Smoking as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, ages 21-77
- Current smoker with ≥5 cigarettes per day for ≥1 year history of smoking
- Screening CO ≥8 ppm
- Not currently interested in quitting smoking
- Willing to briefly switch from combustible to noncombustible nicotine
- Have reliable daily access to a smartphone or tablet compatible with the iCO Smokerlyzer app:
- Android 8 or higher, iOS 8 or higher
- Bluetooth-enabled device
Who cannot join
- Current use of smoking cessation medications such as varenicline or bupropion
- Major chronic medical problems, including cardiovascular disease, diabetes
- Pregnancy (a urine pregnancy test will be administered at screening for all women of child bearing potential).
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Initial Cross-over Test of a Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine in Smokers
A novel heat-not-burn tobacco product (IQOS) will be provided to smokers, compared against a (cigarette) smoking as usual period in counter-balanced order in a cross-over design. This study will examine the short-term effects of IQOS, switching from combustible to noncombustible nicotine and withdrawal-related symptoms over a two week-long "practice" period, relative to smoking as usual.
Read the detailed description
The current within-subjects crossover study aims to directly compare initial efficacy of IQOS vs (cigarette) smoking as usual on switching from tobacco cigarettes during two-week "practice" periods in smokers.
Study interventions include IQOS, a commercially available, over the counter product. The IQOS is a commercially available tobacco product that consists of a holder which contains a rechargeable battery and an electronically heated metal blade.
All procedures will take place in the Prevention and Early Detection Center (PEDC) at the UPMC Hillman Cancer Center. Participants will be assessed daily via remote CO assessment and online questionnaire throughout the entire study (WK1-WK5). At the end of a one-week baseline of normal smoking (WK1), participants will be randomized to either: 1) begin a two-week period of attempting to completely switch to exclusive IQOS use (IQOS First); or 2) continue to smoke as usual (IQOS Last; WK2-WK3), followed by a second two-week period during which they will smoke as usual or attempt to switch to IQOS (opposite of the first period; WK4-WK5).
- Conditions
- Smoking Behaviors
- Being tested
- IQOS, Smoking as Usual
- Keywords
- HnB: heat not burn tobacco product, IQOS: commercially available HnB manufactured
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQOSOther
IQOS is a heat-not-burn tobacco product (consisting of an electronic heating device and Heatstick tobacco rods).
Smoking as UsualOther
Cigarette smoking
| Study group | Role | What they receive |
|---|---|---|
| IQOS / Smoking as usual | Experimental | Two weeks of IQOS, followed by two weeks of cigarette smoking as usual. Receives: Other: IQOS; Other: Smoking as Usual |
| Smoking as usual / IQOS | Active comparator | Two weeks of cigarette smoking as usual, followed by two weeks of IQOS. Receives: Other: IQOS; Other: Smoking as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective smoke exposure
Assessed daily using a mobile carbon monoxide monitor (iCO) provided to participants. Carbon monoxide (CO) readings parts per million (ppm) will be submitted directly via email using the iCO smartphone app.
Measured: Up to 5 weeks
Self-reported smoke exposure
Assessed daily using self-reported cigarette consumption, with values submitted via online Qualtrics survey.
Measured: Up to 5 weeks
Harm exposure - Lung function
Lung function will be assessed using standard pulmonary function test.
Measured: Up to 5 weeks
Harm exposure - Blood pressure
Blood pressure will be assessed using a sphygmomanometer.
Measured: Up to 5 weeks
Secondary outcomes (2)
Cigarette craving
Cigarette craving measured daily via Qualtrics using the Questionnaire of Smoking Urges Brief version. This will be measured on a 0-100 visual analog scale. Higher scored indicate greater craving.
Measured: Up to 5 weeks
Withdrawal symptoms
Withdrawal symptoms measured daily via Qualtrics using the Minnesota Nicotine Withdrawal Scale. This will be measured on a 0-18 scale. Higher scores indicate greater withdrawal symptoms.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start23 Jun 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Why it stopped: Investigator left institution and did not retain the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Min Yuan, MD, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861428
- Sponsor's protocol ID
- HCC 20-245
- Acronym
- IQOS
- Status last verified
- Apr 2024
- First submitted
- 13 Apr 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Cross-over Test of a Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine in Smokers
- ClinicalTrials.gov ID
- NCT04861428
- Acronym / sponsor ID
- IQOS / HCC 20-245
- Conditions
- Smoking Behaviors
- Keywords
- HnB: heat not burn tobacco product, IQOS: commercially available HnB manufactured
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left institution and did not retain the study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 27 Apr 2021 (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.
A novel heat-not-burn tobacco product (IQOS) will be provided to smokers, compared against a (cigarette) smoking as usual period in counter-balanced order in a cross-over design. This study will examine the short-term effects of IQOS, switching from combustible to noncombustible nicotine and withdrawal-related symptoms over a two week-long "practice" period, relative to smoking as usual.
Detailed description
The current within-subjects crossover study aims to directly compare initial efficacy of IQOS vs (cigarette) smoking as usual on switching from tobacco cigarettes during two-week "practice" periods in smokers.
Study interventions include IQOS, a commercially available, over the counter product. The IQOS is a commercially available tobacco product that consists of a holder which contains a rechargeable battery and an electronically heated metal blade.
All procedures will take place in the Prevention and Early Detection Center (PEDC) at the UPMC Hillman Cancer Center. Participants will be assessed daily via remote CO assessment and online questionnaire throughout the entire study (WK1-WK5). At the end of a one-week baseline of normal smoking (WK1), participants will be randomized to either: 1) begin a two-week period of attempting to completely switch to exclusive IQOS use (IQOS First); or 2) continue to smoke as usual (IQOS Last; WK2-WK3), followed by a second two-week period during which they will smoke as usual or attempt to switch to IQOS (opposite of the first period; WK4-WK5).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IQOS / Smoking as usual | Experimental | Other: IQOS, Other: Smoking as UsualTwo weeks of IQOS, followed by two weeks of cigarette smoking as usual. |
| Smoking as usual / IQOS | Active comparator | Other: IQOS, Other: Smoking as UsualTwo weeks of cigarette smoking as usual, followed by two weeks of IQOS. |
Who may qualify
- Ages
- 21 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, ages 21-77
- Current smoker with ≥5 cigarettes per day for ≥1 year history of smoking
- Screening CO ≥8 ppm
- Not currently interested in quitting smoking
- Willing to briefly switch from combustible to noncombustible nicotine
Key exclusion criteria (3 listed)
- Current use of smoking cessation medications such as varenicline or bupropion
- Major chronic medical problems, including cardiovascular disease, diabetes
- Pregnancy (a urine pregnancy test will be administered at screening for all women of child bearing potential).
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 |
|---|---|---|
| IQOSIQOS is a heat-not-burn tobacco product (consisting of an electronic heating device and Heatstick tobacco rods). | Other | IQOS / Smoking as usual, Smoking as usual / IQOS |
| Smoking as UsualCigarette smoking | Other | IQOS / Smoking as usual, Smoking as usual / IQOS |
Primary outcome
Objective smoke exposure
Time frame: Up to 5 weeks
Assessed daily using a mobile carbon monoxide monitor (iCO) provided to participants. Carbon monoxide (CO) readings parts per million (ppm) will be submitted directly via email using the iCO smartphone app.
Self-reported smoke exposure
Time frame: Up to 5 weeks
Assessed daily using self-reported cigarette consumption, with values submitted via online Qualtrics survey.
Harm exposure - Lung function
Time frame: Up to 5 weeks
Lung function will be assessed using standard pulmonary function test.
Harm exposure - Blood pressure
Time frame: Up to 5 weeks
Blood pressure will be assessed using a sphygmomanometer.
2 secondary outcomes
Cigarette craving
Time frame: Up to 5 weeks
Withdrawal symptoms
Time frame: Up to 5 weeks
Results and safety
The study was stopped early (reason given: Investigator left institution and did not retain the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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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 IQOS and Smoking as Usual in people with Smoking Behaviors, run by University of Pittsburgh 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 3 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 4 Apr 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?
The study was stopped early (reason given: Investigator left institution and did not retain the study). Results are not available in the source record.
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?
Objective smoke exposure (time frame: Up to 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2024.