NCT02328794

Randomized Clinical Trial to Reduce Harm From Tobacco

Completed NA Last updated 2 May 2017

What this trial tests

NA trial testing E-cigarette free access in Smoking Cessation in 6,006 participants. Completed in 20 April 2017.

Timeline

1 January 2015

Primary endpoint
5 November 2016

20 April 2017

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	6,006
Start date	1 January 2015
Primary completion	5 November 2016
Estimated completion	20 April 2017
Sites	1 location across United States

Drugs / interventions tested

• E-cigarette free access
• E-cigarette/NRT/Zyban/Chantix Choice
• Outcome Incentive arm
• Loss framing incentive arm
• Control

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 99, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to determine the effectiveness of 4 different interventions aimed at smoking cessation, two of which are incentive structures that are each grounded in behavioral economic principles. The other interventions will determine the effectiveness of various cessation aids, including electronic cigarettes and text messaging, on smoking cessation. This study will be conducted as an opt-out procedure where participants are automatically enrolled in the program but have the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate the effects of such programs in an employee based population that can be easily mimicked in other employee based populations.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mobile phone-based interventions for smoking cessation.
   Whittaker R, McRobbie H, Bullen C, Rodgers A, et al · · 2016 · cited 372× · PMID 27060875 · DOI 10.1002/14651858.cd006611.pub4
2. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Bullen C, Begh R, et al · · 2016 · cited 325× · PMID 27622384 · DOI 10.1002/14651858.cd010216.pub3
3. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Lindson N, Bullen C, et al · · 2020 · cited 314× · PMID 33052602 · DOI 10.1002/14651858.cd010216.pub4
4. Nicotine receptor partial agonists for smoking cessation.
   Cahill K, Lindson-Hawley N, Thomas KH, Fanshawe TR, et al · · 2016 · cited 228× · PMID 27158893 · DOI 10.1002/14651858.cd006103.pub7
5. A Pragmatic Trial of E-Cigarettes, Incentives, and Drugs for Smoking Cessation.
   Halpern SD, Harhay MO, Saulsgiver K, Brophy C, et al · · 2018 · cited 158× · PMID 29791259 · DOI 10.1056/nejmsa1715757
6. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, Lindson N, Butler AR, McRobbie H, et al · · 2022 · cited 147× · PMID 36384212 · DOI 10.1002/14651858.cd010216.pub7
7. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Lindson N, Bullen C, et al · · 2021 · cited 126× · PMID 33913154 · DOI 10.1002/14651858.cd010216.pub5
8. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Butler AR, Lindson N, et al · · 2021 · cited 106× · PMID 34519354 · DOI 10.1002/14651858.cd010216.pub6