Evolution Research Group | Woodland Research Northwest
Status
Conditions
Treatments
About
The purpose of the study is to evaluate changes in biomarkers of exposure (BoE) to harmful and potentially harmful constituents (HPHCs) in adult smokers who completely switch to Ploom heated tobacco products (HTPs) compared to those who continue to smoke usual brand combustible cigarettes (UBCC).
Full description
This is a multi-site, open-label, two-group (menthol and non-menthol), six-arm (HTP, Continue Smoking, and Smoking Abstinence arms within each group) randomized, clinical study to evaluate changes in BoEs in adult smokers who remain smoking, switch to the Ploom HTP, or abstain from smoking, for 60 days (5 days in clinic followed by a 55-day ambulatory phase). Target enrollment is 300 male and female adult smokers between the ages of 22 and 65 in overall good health.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Voluntary consent to participate in this study documented on the signed ICF.
Score 5 or higher (moderate dependence or higher) on the FTCD.
Healthy adult males and females ≥ 22 and ≤ 65 years of age, inclusive, at Screening.
Smoking history (self-reported at screening) of an average of at least 10 but no more than 30 factory-manufactured combustible cigarettes (either menthol or non-menthol) daily for at least 12 months prior to screening. Brief periods (ie, up to 7 consecutive days) of non-smoking during the 3 months prior to screening (eg, due to illness or participation in a study where smoking was prohibited) will be permitted.
Screening and first check-in blood pressure ≤ 150/90 mmHg measured after being seated for at least 10 minutes. Two rechecks may be performed at the Principal Investigator's discretion.
Positive urine cotinine (≥ 500 ng/mL) at screening.
Exhaled carbon monoxide (eCO) ≥ 10 ppm at screening.
Post-bronchodilator forced expired volume in 1 second (FEV1) : forced vital capacity (FVC) ratio > 0.7 and FEV1 > 80% of predicted at screening.
Negative pregnancy test at Screening and first check-in (Day -2) for all female subjects.
Female subjects who are heterosexually active and of childbearing potential (eg, neither surgically sterile at least 6 months prior to first check-in nor postmenopausal with amenorrhea for at least 12 months prior to first check-in with follicle-stimulating hormone [FSH] levels consistent with postmenopausal status) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study:
Female subjects who are of nonchildbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to first check-in:
Willing to comply with the requirements of the study.
Willing to use Ploom HTP after the Product Trial at first check-in.
Willing and able to abstain from cigarettes from Day 1 through the end of the study (EOS) on Day 60 (±3 days) if they are randomized to a Smoking Abstinence arm.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
300 participants in 6 patient groups
Loading...
Central trial contact
Jeffery S Edmiston, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal