Eligibility Details:
Inclusion Criteria:
- Subject has signed informed consent and has agreed to all study related procedures
- Have a telephone and address where they may be reached
- Able to follow verbal and written instructions in English
- Be the only participant in their household
- Interested in trying novel nicotine products
- Daily smokers: greater than or equal to 1 cigarette/little cigar per day
- Intermittent smokers: greater than or equal to 1 cigarette/little cigar per day 4 to
27 days per month
Exclusion Criteria:
- Unwilling to refrain from other e-cigarette use for the duration of the study, other
than what is provided to them for study purposes
- Positive urine screen for illicit drugs except marijuana
- Participants with valid prescriptions for opiates, benzodiazepines, barbiturates,
amphetamines or methadone will not be excluded
- Participants failing the urine drug screen (except marijuana which is not
exclusionary) will be allowed to re-screen once. If they test positive again,
they will not be allowed to return)
- Current/recent use of certain medications:
- Smoking cessation meds (past 90 days; e.g., wellbutrin, bupropion, zyban,
nicotine replacement therapy [NRT], chantix)
- Certain medications to treat depression (last 14 days; e.g., amitriptyline)
- A case by case determination will be made by study physician for medication on
the precautionary list, (e.g. nitroglycerin)
- Daily use of opioids for 30 days or more on phone screen or at screening is
exclusionary however pro re nata (PRN) use is allowed (e.g., 3 to 7 days per week
or less or if more frequent, use less than a month's duration
- Unstable medical condition as determined by the medical team
- Subject experienced abnormal heart rhythms or cardiovascular disease (stroke, chest
pain, heart attack) in the last 3 months
- Subject's screening blood pressure reading greater than or equal to 180/110
- Meet criteria for major depressive syndrome or suicidality on the Patient Health
Questionnaire-9 (PHQ-9)
- Self report of past or current diagnosis of bi-polar disorder or
schizophrenia/schizoaffective disorder
- Other tobacco use besides cigarettes or little cigars (e.g., hookah, cigarillos,
smokeless tobacco, chewing tobacco, pipes, cigars, etc.) on 10 or more days in the
last month
- Recent (past 90 days), current, or planned (within the next 45 days) involvement in
smoking cessation activities
- Positive urine pregnancy test at screening. Women who are two years post-menopausal,
or who have had a tubal ligation or a partial or full hysterectomy will not be subject
to a urine pregnancy test
- Women that are breastfeeding or of childbearing potential and not protected by a
medically acceptable, effective method of birth control while enrolled in the study.
Medically acceptable contraceptives include:
- Approved hormonal contraceptives (such as birth control pills, patches, implants
or injections)
- Barrier methods (such as condom or diaphragm) used with a spermicide, or
- An intrauterine device (IUD)
- Contraceptives sold for emergency use after unprotected sex are not acceptable
methods for routine use
- Subject considered by the investigator to be unsuitable to participate in the study
(e.g., due to cognitive deficits or instability to last the entire duration of the
study)
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
