NCT03492463

The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin patches containing nicotine affects switching from smoking conventional combustible (burning) cigarettes.

Detailed description

This study proposes to assess the relative role of nicotine dose and route of delivery in affecting successful switching from combustible cigarettes to e-cigarettes, as well as concomitant reductions in ad libitum cigarette smoking and exposure to harmful and potentially harmful constituents of combustion. The strategy will be to assess adoption of e-cigarette use and concomitant reduction in ad libitum smoking of subjects' usual brands of cigarettes over an 8-week period, during which they will receive nicotine or non-nicotine e-cigarettes, and nicotine skin patches. The nicotine patches will not be used as a therapeutic treatment in this study, but rather as a way to manipulate the nicotine dose, while varying the rate and route of nicotine delivery. Behavioral or "habit" aspects of e-cigarette use will be controlled for by the groups receiving non-nicotine e-cigarettes. Initially the study design included placebo patch control conditions, but due to limitations in budget and period of support, enrollment in these these arms was discontinued. All participants currently receive active nicotine patches.

Conditions

• Nicotine Dependence, Cigarettes

Interventions

Type	Name	Description
DRUG	Nicotine patch	Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
OTHER	Placebo patch	Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
OTHER	E-cigarettes	Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
OTHER	Non-nicotine e-cigarettes	Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.

Timeline

• Start date: 2018-08-06
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2018-04-10
• Last updated: 2023-02-08
• Results posted: 2022-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study