Characterization of Biomarkers of Tobacco Exposure, Urge-to-Smoke Following Exclusive and Dual Ad Lib Use of Electronic Cigarettes

NCT02385227 | Completed DMC

• 1 other identifier: DaVinci
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, forced-switch, parallel, proof-of-concept study to assess exposure to biomarkers of tobacco exposure following short-term ad lib use of three blu e-cigarette products. The primary objectives of this study are to:

1. 1.Compare changes in selected urine and blood biomarkers of tobacco exposure within cohorts following a 5-day forced-switch from usual brand conventional combustible cigarettes to exclusive use of blu e-cigarettes, dual use of blu e cigarettes and the subject's usual brand combustible cigarette, or smoking cessation.
2. 2.Compare changes in selected urine and blood biomarkers of tobacco exposure among cohorts following a 5-day forced-switch from usual brand conventional combustible cigarettes to exclusive use of a blu e cigarette, dual use of a blu e-cigarette and the subject's usual brand combustible cigarette, or smoking cessation.
3. 3.Compare changes in selected physiological endpoints affected by tobacco exposure within cohorts during a 5-day forced-switch from usual brand conventional combustible cigarettes to exclusive use of blu e cigarettes, dual use of blu e cigarettes and the subject's usual brand combustible cigarette, or smoking cessation.
4. 4.Compare changes in selected physiological endpoints affected by tobacco exposure among cohorts following a forced-switch to exclusive use of a blu e cigarette, dual use of a blu e-cigarette and the subject's usual brand combustible cigarette, or smoking cessation.
5. 5.Determine daily nicotine consumption from blu e-cigarettes following exclusive use of blu e cigarettes or dual use of blu e-cigarettes and the subject's usual brand combustible cigarette over a 5-day period.
6. 6.Assess the effectiveness of exclusive use of blu e-cigarettes or dual use of blu e-cigarettes and the subject's usual brand combustible cigarette to reduce the urge to smoke.
7. 7.Assess subject opinions of various characteristics of blu e-cigarettes.
8. 8.Assess the safety and tolerability of short-term use of blu e-cigarettes.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (3)

• Biomarkers of tobacco exposure as measured in urine

  Excretion of each urine biomarker of exposure (NNAL, nicotine equivalents, 3-HPMA, HMPMA, CEMA, 1-OH pyrene, NNN, MHBMA, and S-PMA) will be assessed at baseline and following a 5-day forced switch to determine changes associated with product use or cessation, and differences between cohorts.

  5 days

• Biomarkers of tobacco effect as measured in urine

  Excretion of F2-isoprostane (8-iso-PGF2 Type III) will be assessed at baseline and following a 5-day forced switch to determine changes associated with product use or cessation, and differences between cohorts.

  5 days

• Biomarkers of tobacco exposure as measured in blood

  Exposure to each blood biomarker of exposure (COHb, nicotine, cotinine, and trans-3'hydroxycotinine) will be assessed at baseline and during a 5-day forced switch to determine changes associated with product use or cessation, and differences between cohorts.

  5 days

Secondary Outcomes (8)

• Daily product consumption as measured by e-cigarette and combustible cigarette use

  5 days

• Urge to smoke as measured by visual analog scale

  5 days

• Physiologic effects as measured by spirometry

  5 days

• Physiologic effects as measured by exhaled breath

  5 days

• Physiologic effects as measured by blood pressure and pulse rate

  5 days

Study Arms (7)

Cohort A1

EXPERIMENTAL

Exclusive blu™ e-cigarette A1

Other: Exclusive blu™ e-cigarette A1

Cohort A2

EXPERIMENTAL

Exclusive blu™ e-cigarette A2

Other: Exclusive blu™ e-cigarette A2

Cohort A3

EXPERIMENTAL

Exclusive blu™ e-cigarette A3

Other: Exclusive blu™ e-cigarette A3

Cohort B1

EXPERIMENTAL

Dual blu™ e-cigarette and usual brand B1

Other: Dual blu™ e-cigarette and usual brand B1

Cohort B2

EXPERIMENTAL

Dual blu™ e-cigarette and usual brand B2

Other: Dual blu™ e-cigarette and usual brand B2

Cohort B3

EXPERIMENTAL

Dual blu™ e-cigarette and usual brand B3

Other: Dual blu™ e-cigarette and usual brand B3

Cohort C

EXPERIMENTAL

Nicotine product cessation C

Other: Nicotine product cessation C

Interventions

Exclusive blu™ e-cigarette A1 OTHER

Classic Tobacco rechargeable e cigarette

Cohort A1

Exclusive blu™ e-cigarette A2 OTHER

Magnificent Menthol rechargeable e cigarette

Cohort A2

Exclusive blu™ e-cigarette A3 OTHER

Cherry Crush rechargeable e cigarette

Cohort A3

Dual blu™ e-cigarette and usual brand B1 OTHER

Classic Tobacco rechargeable e cigarette and a usual brand combustible cigarette

Cohort B1

Dual blu™ e-cigarette and usual brand B2 OTHER

Magnificent Menthol rechargeable e cigarette and a usual brand combustible cigarette

Cohort B2

Dual blu™ e-cigarette and usual brand B3 OTHER

Cherry Crush rechargeable e cigarette and a usual brand combustible cigarette

Cohort B3

Nicotine product cessation C OTHER

Nicotine cessation

Cohort C

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult male and female smokers, 21 to 65 years of age, inclusive, at Screening.
• Combustible cigarette smoker for at least 12 months prior to Check-in. Brief periods of non-smoking during the 90 to 14 days prior to Check-in (e.g., up to \~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) will be permitted at the discretion of the Investigator.
• Currently smokes an average of 10 or more king size (\~83 - 85 mm) or 100s (\~98 - 100 mm) manufactured combustible cigarettes per day (any brand style).
• Consistent use of a single brand style for 14 days prior to Check-in.
• Positive urine cotinine at Screening (≥ 500 ng/mL).
• Exhaled CO \> 12 ppm at Screening.
• Female subjects of non-childbearing potential and of childbearing potential will be eligible. Examples of acceptable forms of contraception include, but are not limited to, the following.
• Surgeries:Hysterectomy at least 6 months prior to product administration; Oophorectomy at least 6 months prior to product administration; Tubal ligation at least 6 months prior to product administration
• Transcervical sterilization at least 6 months prior to product administration
• Hormonal birth control at least 3 months prior to product administration
• Non-hormonal intrauterine device at least 3 months prior to product administration
• Double barrier methods (e.g., condom and spermicide) at least 14 days prior to product administration
• Abstinence at least 14 days prior to product administration
• Vasectomized partner is acceptable birth control for females provided the surgery was performed at least 6 months prior to product administration
• Postmenopausal at least 1 year prior to product administration and confirmed by follicle stimulating hormone (FSH) test at Screening.

You may not qualify if:

• History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary (especially bronchospastic diseases), immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Clinically significant abnormal findings on the physical examination, medical history, ECG, or clinical laboratory results at Screening or Check-in, in the opinion of the Investigator.
• Positive test for HIV, HbsAg, or HCV.
• An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 2 weeks prior to Check-in.
• Fever (\>100.2F) at Screening or at Check-in.
• Systolic blood pressure \>150 mmHg, diastolic blood pressure \>95 mmHg, or pulse rate \>99 bpm at Screening.
• BMI \<18 kg/m2 or \>40 kg/m2 at Screening.
• Female subjects who are pregnant, lactating, or intend to become pregnant from Screening through completion of study.
• Use of prescription anti-diabetic medication and/or insulin therapy within 12 months of Check-in.
• Use of medications or foods known or are suspected to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disullfiram, entacapone, fenofibrate, isoniazid, grapefruit, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital, selegiline, sulconazole, tioconazole, tranylcypromine,) within 14 days or five half-lives of the drug, whichever is longer, prior to Check-in.
• Use of inhalers to treat any medical condition within 3 months prior to Check-in and throughout the study.
• Positive urine screen for alcohol or drugs of abuse at Screening or at Check-in.
• History of drug or alcohol abuse within 24 months prior to Check-in.
• Plasma donation within 7 days prior to Check-in.
• Donation of blood or blood products, had significant blood loss, or received whole blood or a blood product transfusion within 56 days prior to Check-in.

Sponsors & Collaborators

• Lorillard Tobacco Company: lead
• Celerion: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Related Publications (1)

• D'Ruiz CD, Graff DW, Robinson E. Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes. BMC Public Health. 2016 Jul 11;16:543. doi: 10.1186/s12889-016-3236-1.

  PMID: 27401980 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Michael R. Gartner, M.D.

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: March 11, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

US (1)