Changes in Biomarker of Exposure in Adults Who Smoke Cigarettes Switching From Cigarettes to Heated Tobacco Products

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:
• hormonal (eg, oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to first check-in, when used in combination with male condoms with spermicide (use of NuvaRing® is at the Principal Investigator's discretion)
• double barrier (eg, condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to first check-in
• intrauterine device or system (utilize Principal Investigator discretion regarding use of hormonal or nonhormonal devices) for at least 3 months prior to first check-in
• exclusive partner who is clinically sterile (ie, documented infertility or surgical sterilization; see below for additional information on sterility) or has been vasectomized for at least 6 months (inclusive) prior to first check-in Note: Sexual abstinence, defined as refraining from intercourse, is allowed when this is in line with the preferred and usual lifestyle of the subject. Female subjects of childbearing potential who are not currently engaging in heterosexual intercourse must agree to use one of the above methods of birth control through completion of study, in the event that they have heterosexual intercourse during the course 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:
• Hysteroscopic sterilization (including Essure® or similar nonsurgical sterilization procedures);
• bilateral tubal ligation or bilateral salpingectomy;
• hysterectomy;
• bilateral oophorectomy Or be postmenopausal with amenorrhea for at least 12 months prior to first check-in and have FSH levels consistent with postmenopausal status.
• 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

• Use of any type of tobacco- or nicotine-containing products other than manufactured cigarettes (eg, e-vapor products, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge