Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks
Public ClinicalTrials.gov record NCT02396381. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Controlled, 2-arm Parallel Group, Multi-center Study, to Evaluate Biological and Functional Changes in Healthy Smokers Switching to Tobacco Heating System 2.2 (THS 2.2) Compared to Continuing Smoking Conventional Cigarettes for 26 Weeks in an Ambulatory Setting
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of the study is to demonstrate clinical, biological and functional health changes in smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2 (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a 26-week period. To characterize the study as successful, at least 5 clinical risk endpoints should move in the direction of smoking cessation and these results would be statistically significant. The main analysis will be defined a priori (using the Hailperin-Ruger approach) and will be made between THS 2.2 use and CC use as "per actual product used" and product use categories.
Study identification
- NCT ID
- NCT02396381
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,039 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 30 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 12, 2015 (Actual)
- Primary completion
- Sep 13, 2016 (Actual)
- Completion
- Aug 1, 2017 (Actual)
- Last update posted
- Jan 26, 2023
2015 – 2017
United States locations
- U.S. sites
- 19
- U.S. states
- 9
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Celerion Arizona | Tempe | Arizona | 85283 | — |
| Clinical Research West Florida | Clearwater | Florida | 33765 | — |
| Covance, Inc | Daytona Beach | Florida | 32117 | — |
| Compass Research | Orlando | Florida | 32806 | — |
| Clinical Research West Florida | Tampa | Florida | 33603 | — |
| Compass Research | The Villages | Florida | 32162 | — |
| Central Kentucky Research Associate | Lexington | Kentucky | 40509 | — |
| Celerion Lincoln | Lincoln | Nebraska | 68502 | — |
| PMG Research of Cary | Cary | North Carolina | 27518 | — |
| PMG Research of Charlotte | Charlotte | North Carolina | 28209 | — |
| PMG Research of Raleigh | Raleigh | North Carolina | 27609 | — |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| PMG Research of Bristol | Bristol | Tennessee | 37620 | — |
| NOCCR | Knoxville | Tennessee | 37920 | — |
| Benchmark | Austin | Texas | 78705 | — |
| Benchmark | Fort Worth | Texas | 76135 | — |
| Benchmark | San Angelo | Texas | 76904 | — |
| National Clinical Research | Richmond | Virginia | 23294 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02396381, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 26, 2023 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02396381 live on ClinicalTrials.gov.