NCT04255459

Brief Summary

This is a multicenter, post market surveillance study designed to evaluate biomarkers of tobacco exposure and effect, health status measurements, and tobacco product usage patterns in subjects who are natural adopters of cigarettes and/or smokeless tobacco. Non tobacco users will serve as a non use comparison group. This study is unblinded by necessity due to the very different visual appearance of the subject's Usual Brand (UB) of tobacco product(s).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2010

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

September 4, 2019

Last Update Submit

January 31, 2020

Conditions

Smoking, TobaccoSmoking Behaviors

Outcome Measures

Primary Outcomes (43)

  • Urine creatinine

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Urine nicotine and 9 metabolites

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Tobacco specific nitrosamines in urine

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Acrolein metabolite and acrylamide metabolites in urine

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Crotonaldehyde metabolite in urine

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Benzene metabolite in urine

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • 1,3 Butadiene metabolites in urine

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Aromatic amines in urine

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Polycyclic aromatic hydrocarbons metabolites in urine

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Thiocyanate in urine

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Urinary mutagen uptake in strains TA98 and YG1024

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Isoprostanes and metabolites; prostaglandin PGF2alpha in urine

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Blood nicotine and cotinine

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Thiocyanate in blood

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Carboxyhemoglobin in blood

    To establish baseline values for tobacco exposure biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • 4-Aminobiphenyl hemoglobin adducts in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Amino Acids in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Glycated hemoglobin in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Total cholesterol in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Triglycerides in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Low density lipoprotein cholesterol in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • High density lipoprotein cholesterol in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Very low density lipoprotein cholesterol in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Apolipoprotein A1 in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Apolipoprotein A2 in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Apolipoprotein B100 in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Lipoprotein(a) in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Oxidized low density lipoprotein in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Folate in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Fibrinogen in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Tissue inhibitor of metalloproteinase 1 in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • hsC-reactive protein in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • alpha-1-antitrypsin in blood

    To establish baseline values for tobacco effect biomarker levels of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Tar (mg/day) and nicotine (mg/day) from subject's in-clinic cigarette use OR nicotine (mg/day) from subject's in-clinic snus use

    To establish baseline values for mouth-level exposure of natural adopters for the product classes of cigarettes and snus.

    After 1 day of product usage

  • Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by the Dyspnea Modified Borg Scale, pre- and post-6MWT.

    To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by the Overall Fatigue Modified Borg Scale, pre- and post-6MWT.

    To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by heart rate (beats/minute), pre- and post-6MWT.

    To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by oxygen saturation (% SpO2), pre- and post-6MWT.

    To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by spirometry (FEV1 % predicted), pre- and post-6MWT.

    To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Functional capacity of subjects completing a 6 Minute Walk Test (6MWT) as assessed by spirometry (FEV1 /FVC ratio), pre- and post-6MWT.

    To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Current self-reported health status as measured by the Fagerström Test for Nicotine Dependence.

    To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Current self-reported health status as measured by the Smoking Cessation Quality of Life Questionnaire (SCQoL, inclusive of the Short Form Health Survey [SF-36v2]).

    To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

  • Current self-reported health status as measured by the American Thoracic Society Division of Lung Disease Questionnaire (ATS-DLD-78-A).

    To establish baseline values for health status of natural adopters of each product class and of non-tobacco users.

    After 1 day of product usage

Study Arms (6)

Moist Snuff users

OTHER

Subjects for whom moist snuff is their usual brand of tobacco product.

Other: Moist Snuff

Camel Snus users

OTHER

Subjects for whom Camel Snus is their usual brand of tobacco product.

Other: Camel Snus

Dual users of Camel Snus and cigarette

OTHER

Subjects who use both Camel Snus and cigarettes as their usual brands of tobacco products.

Other: Camel SnusOther: Cigarettes

Dual users of moist snuff and cigarettes

OTHER

Subjects who use both moist snuff and cigarettes as their usual brands of tobacco products.

Other: Moist SnuffOther: Cigarettes

Cigarette smokers

OTHER

Subjects for whom cigarettes is their usual brand of tobacco product.

Other: Cigarettes

Non-tobacco users

OTHER

Subjects who do not use tobacco products.

Other: No tobacco usage

Interventions

Moist SnuffOTHER

Moist Snuff product

Dual users of moist snuff and cigarettesMoist Snuff users
Camel SnusOTHER

Camel Snus product

Camel Snus usersDual users of Camel Snus and cigarette
CigarettesOTHER

Cigarette product

Cigarette smokersDual users of Camel Snus and cigaretteDual users of moist snuff and cigarettes
No tobacco usageOTHER

No tobacco usage

Non-tobacco users

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to comprehend and willing to sign an informed consent form.
  • Male or female subjects at least 19 years of age.
  • Able to safely perform all study procedures, as determined by the site Investigator.
  • Willing to perform all study procedures and to consume only the meals/snacks provided while confined to the clinic.
  • Agree to not use drugs of abuse over the course of the study, and test negative for drugs of abuse.
  • Test negative for breath alcohol (by breathalyzer).
  • For tobacco users: do NOT intend to quit smoking nor intend to quit using oral smokeless tobacco products (STP) leading up to study participation (defined as planning a quit attempt within a month of the Initial Screening Visit).
  • For tobacco users: willing to abstain from tobacco use for up to 10 hours during overnight confinement in the clinic.
  • Able to read, understand, and complete questionnaires in English.
  • Meet cohort specific requirements as follows:
  • Moist Snuff Users: Must be exclusive moist snuff users of any brand, any style, and any flavor who self-report using on average ≥ 1 can per week for at least 6 months prior to study entry, have an expired carbon monoxide (ECO) level of 0 to 5 ppm, and have a positive urine cotinine screen. Note: Subjects with an ECO level of 6 to 10 ppm may be included upon joint review by the Sponsor and Investigator.
  • Camel SNUS Users: Must be exclusive Camel SNUS users of any variety who self report using on average ≥ 1 tin per week for at least 6 months prior to study entry, have an ECO level of 0 to 5 ppm, and have a positive urine cotinine screen. Note: Subjects with an ECO level of 6 to 10 ppm may be included upon joint review by the Sponsor and Investigator.
  • Dual Camel SNUS/Cigarette Users: Must be dual users of Camel SNUS and allowed commercial filtered tobacco burning cigarettes, using on average ≥ 1 tin of Camel SNUS per week and smoking ≥ 5 cigarettes daily for at least 6 months prior to study entry. The subject's ECO level must be from 5 to 100 ppm, and the urine cotinine screen must be positive.
  • Dual Moist Snuff/Cigarette Users: Must be dual users of moist snuff and allowed commercial filtered tobacco burning cigarettes, using on average ≥ 1 can of snuff per week and smoking ≥ 5 cigarettes daily for at least 6 months prior to study entry. The subject's ECO level must be from 5 to 100 ppm, and the urine cotinine screen must be positive.
  • Cigarette Smokers: Must be exclusive cigarette smokers (of allowed commercial filtered tobacco burning cigarettes) who self-report smoking on average ≥ 10 cigarettes daily for at least 6 months prior to study entry, have an ECO level of 10 to 100 ppm, and have a positive urine cotinine screen.
  • +1 more criteria

You may not qualify if:

  • Use of any type of non-tobacco nicotine-containing product/device (e.g., electronic cigarette) or any nicotine replacement therapy (e.g., nicotine patch, nicotine gum, nicotine spray, nicotine inhaler or nicotine lozenge) within 6 months prior to study entry or during the study.
  • Unable to safely perform the study procedures, as determined by the site Investigator. In general, subjects with any of the conditions listed below will be excluded unless individually approved by the Medical Monitor.
  • Uncontrolled hypertension (blood pressure \> 170/110 mmHg at the Initial Screening Visit).
  • Unstable coronary artery disease (Class III-IV angina).
  • Decompensated (Class III-IV) congestive heart failure.
  • Morbid obesity (body mass index \[BMI\] ≥ 40 kg/m2).
  • Uncontrolled diabetes (HgbA1c \> 9.0).
  • Pulmonary disease requiring oxygen therapy or preventing 6 minutes of steady ambulation or preventing completion of triplicate spirometry.
  • Reduced mobility that impairs satisfactory completion of the 6MWT (six minute walk test), such as:
  • i. Clinically significant arthritis of the knee or hip.
  • ii. Claudication with walking 6 minutes or less.
  • iii. Clinically significant ambulation impairment as sequelae of cerebrovascular accident (CVA), sciatica, peripheral nervous disease, or myopathy.
  • iv. Imbalance or other gait disorder requiring assistance of a cane or walker to ambulate.
  • Have a resting heart rate (after being seated for at least 5 minutes) of \> 120 beats per minute (bpm).
  • Had a myocardial infarction within the month prior to the Initial Screening Visit through enrollment into the study.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Avail Clinical Research

DeLand, Florida, 32720, United States

Location

Comprehensive Clinical Development, Inc.

Miramar, Florida, 33025, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Central Kentucky Research Associates (CKRA)

Lexington, Kentucky, 40509, United States

Location

MetaClin Research, Inc.

Austin, Texas, 78749, United States

Location

Community Clinical Research

Austin, Texas, 78754, United States

Location

MeSH Terms

Conditions

Tobacco SmokingSmoking

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

BehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Bobbette Jones, DrPH

    RAIS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2019

First Posted

February 5, 2020

Study Start

February 13, 2010

Primary Completion

August 14, 2010

Study Completion

August 14, 2010

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(6)