Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation

NCT02342795 | Completed Phase 1 DMC

• 2 other identifiers: HM200027595P50DA036105-02
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the influence of novel tobacco products on biomarkers of toxicant exposure and disease risk, reports of adverse events, and concurrent use of other tobacco products. In this case, the novel products are one type of electronic cigarette and an imitation cigarette or cigarette substitute.

Conditions

Nontherapeutic

Outcome Measures

Primary Outcomes (1)

• urine carcinogen biomarker of exposure, NNAL

  changes in NNAL concentration measured at week 0, week 4, week 12, and week 24

  week 24

Secondary Outcomes (2)

• urine biomarker of nicotine exposure, cotinine

  week 24

• blood, urine, and exhaled breath condensate biomarkers of oxidative stress, glutathione and 8 Isoprostanes

  week 24

Study Arms (4)

cigarette substitute

EXPERIMENTAL

The QuitSmart cigarette substitute is a plastic tube that looks like a real cigarette and is designed to provide the same draw resistance as a smoker's usual cigarette. There is no drug delivery with this product. Two cigarette substitutes and a product manual are provided to participants following randomization and replacement products are provided throughout the intervention period (24 weeks).

Other: cigarette substitute

e-cigarette (with 0 mg/ml nicotine)

EXPERIMENTAL

The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 0 mg/ml nicotine will be provided throughout the intervention period (24 weeks).

Other: e-cigarette

e-cigarette (with 8 mg/ml nicotine)

EXPERIMENTAL

The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 8 mg/ml nicotine will be provided throughout the intervention period (24 weeks).

Other: e-cigarette

e-cigarette (with 36 mg/ml nicotine)

EXPERIMENTAL

The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 36 mg/ml nicotine will be provided throughout the intervention period (24 weeks).

Other: e-cigarette

Interventions

e-cigarette OTHER

e-cigarette (with 0 mg/ml nicotine); e-cigarette (with 36 mg/ml nicotine); e-cigarette (with 8 mg/ml nicotine)

cigarette substitute OTHER

cigarette substitute

Eligibility Criteria

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

You may qualify if:

• Age 21-65
• Smoke \>9 cigarettes per day for at least 1 year
• Smoke regular filtered cigarettes or machine-rolled cigarettes with a filter
• CO measurement \>9 ppm at baseline
• No serious quit attempt in the prior 1 month. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion \[used specifically as a quitting aid\], patch, gum, lozenge, inhaler, and nasal spray) in the past 1 month as an indication of treatment seeking.
• Not planning to quit in the next 6 months
• Interested in reducing cigarette consumption
• Willing to attend visits weekly and monthly over a 9-month period (not planning to move, not planning extended vacation, no planned surgeries)
• Read and write in English
• Able to understand and consent

You may not qualify if:

• Pregnant and/or nursing women
• Unstable or significant medical condition in the past 12 months (Recent heart attack or some other heart conditions, stroke, severe angina including high blood pressure if systolic \>159 or diastolic \>99 observed during screening).
• Immune system disorders, respiratory diseases (exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (dialysis) or liver diseases (cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data.
• Use of any non-cigarette nicotine delivery product (pipe, cigar, dip, chew, snus, hookah, ECIGs, strips, sticks) in the past 7 days
• Uncontrolled mental illness or substance abuse or inpatient treatment for these in the past 6 months
• History of difficulty providing or unwilling to provide blood samples (fainting, poor veins, anxiety)
• No surgery requiring general anesthesia in the past 6 weeks
• Use of an ECIG for 5 or more days in the past 28 days or any use in the past 7 days
• Use of marijuana or any illicit drug/prescription drugs for non-medical use daily/almost daily, or weekly in the past 3 months per NIDA Quick Screen
• Use of hand-rolled, roll your own cigarettes
• Known allergy to propylene glycol or vegetable glycerin
• Other member of household is currently participating/participated in the study

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Penn State University: collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (2)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Center for the Study of Tobacco Products

Richmond, Virginia, 23298, United States

Location

Related Publications (4)

• Dahal S, Yingst J, Wang X, Cobb CO, Carrillo M, Hrabovsky S, Bascom R, Lopez AA, Kang L, Maloney S, Halquist M, Foulds J, Veldheer S. Changes in cardiovascular disease risk, lung function and other clinical health outcomes when people who smoke use e-cigarettes to reduce cigarette smoking: an exploratory analysis from a randomised placebo-controlled trial. BMJ Open. 2025 Jun 18;15(6):e098005. doi: 10.1136/bmjopen-2024-098005.

  PMID: 40533223 DERIVED

• Cobb CO, Budd S, Maldonado G, Imran R, Foulds J, Yingst J, Yen MS, Kang L, Sun S, Hall PB, Chowdhury N, Cohen JE; Randomized Control Trial Methods Workgroup of the Center for the Study of Tobacco Products: Member List. Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction. Contemp Clin Trials. 2024 Oct;145:107662. doi: 10.1016/j.cct.2024.107662. Epub 2024 Aug 12.

  PMID: 39142511 DERIVED

• Cobb CO, Foulds J, Yen MS, Veldheer S, Lopez AA, Yingst JM, Bullen C, Kang L, Eissenberg T; Randomised Control Trial Methods Workgroup of the Center for the Study of Tobacco Products. Effect of an electronic nicotine delivery system with 0, 8, or 36 mg/mL liquid nicotine versus a cigarette substitute on tobacco-related toxicant exposure: a four-arm, parallel-group, randomised, controlled trial. Lancet Respir Med. 2021 Aug;9(8):840-850. doi: 10.1016/S2213-2600(21)00022-9. Epub 2021 Apr 12.

  PMID: 33857436 DERIVED

• Lopez AA, Cobb CO, Yingst JM, Veldheer S, Hrabovsky S, Yen MS, Foulds J, Eissenberg T. A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation. BMC Public Health. 2016 Mar 3;16:217. doi: 10.1186/s12889-016-2792-8.

  PMID: 26941050 DERIVED

MeSH Terms

Interventions

Electronic Nicotine Delivery Systems

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Thomas Eissenberg

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 21, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

US (2)