NCT04357379

IQOS (Non-Cigarette Tobacco Product) Pilot Study

Completed NA Results posted Last updated 27 October 2021

What this trial tests

NA trial testing IQOS in Smoking in 10 participants. Completed in 22 October 2020.

Timeline

23 July 2020

Primary endpoint
22 October 2020

22 October 2020

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	10
Start date	23 July 2020
Primary completion	22 October 2020
Estimated completion	22 October 2020
Sites	1 location across United States

Drugs / interventions tested

• IQOS

Conditions studied

• Smoking — all drugs for Smoking →
• Tobacco Use — all drugs for Tobacco Use →

Sponsor

Medical University of South Carolina

Who can join

21 and older, any sex, with Smoking or Tobacco Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Prefer IQOS Primary · Lab Visit 2, occurring approximately one week after the initial screening/baseline visit

Participants complete a preference assessment in which they choose between the IQOS or a traditional cigarette in a series of trials. The outcome of this assessment is the number of participants who prefer the IQOS over a traditional cigarette

Group	Value	95% CI
IQOS Group	7

Cigarettes Per Day Secondary · Week 2 of study

The average percent reduction in cigarettes per day observed in Week 2

Group	Value	95% CI
IQOS Group	16.1	± 32.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IQOS Group

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (4 terms — click to expand)

Reaction	System	IQOS Group
Cough	General disorders	—
Headache	General disorders	—
Nausea	General disorders	—
ER visit for medication refill	General disorders	—

Data from ClinicalTrials.gov NCT04357379 adverse events section.

Sponsor's own description

A novel type of non-cigarette tobacco product was recently approved for sale in the US, the heated tobacco product (HTP) IQOS. IQOS may be less harmful than cigarettes, and there are some reports that it may produce more rewarding subjective effects compared to e-cigarettes. The approval of IQOS provides a unique opportunity to gather preliminary data surrounding IQOS. The goal of this pilot study is to assess the subjective effects and relative reinforcement value of IQOS, including its downstream effects on cigarette smoking. Current smokers will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit. During the in-person lab visit, participants (n=10) will sample a traditional cigarette and a novel IQOS tobacco product. Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the IQOS and their own cigarette. Finally, participants will take home a tobacco product they sampled to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.