NCT04058717

Low Nicotine Cigarettes Plus Electronic Cigarettes

Randomized Trial of Low Nicotine Cigarettes Plus Electronic Cigarettes in Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study aims to determine the health effects of very low nicotine content in cigarettes, in conjunction with the availability of nicotine-containing electronic cigarettes (e-cigs) among smokers with mental health conditions (SMHC).

Detailed description

The specific objective of this study is to recruit a cohort of 240 current exclusive daily SMHC (diagnosed using the MINI International Neuropsychiatric Interview) and to measure a comprehensive battery of behavioral and health indicators at 4, 8, 12 and 16 weeks after being randomized to use either normal nicotine content (NNC) Spectrum cigarettes (11.6 mg nicotine/cigarette) or very low nicotine content (VLNC) Spectrum cigarettes (0.2 mg nicotine/cigarette) while also having access to an electronic cigarette (containing either 0 nicotine or high nicotine e-liquid) in a randomized double-blind, placebo-controlled, 2 by 2 design. All participants will be followed up with a study visit 4 weeks after the final randomized visit to identify whether they have continued to use e-cigs/cigarettes and to assess their motivation in smoking abstinence. Our central hypothesis is that key markers of harms to health (e.g. urinary NNAL, exhaled carbon monoxide, measures of addiction, and mental distress) will be significantly improved among SMHC who are provided VLNC cigarettes and high nicotine e-cigs.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
OTHER	Normal Nicotine Content research cigarettes	Research cigarettes with 11.6 mg nicotine/cigarette.
OTHER	High Nicotine e-cigarette	E-cigarette containing high nicotine e-liquid
OTHER	Very Low Nicotine Content research cigarettes	Research cigarettes with 0.2 mg nicotine/cigarette.
OTHER	Zero Nicotine e-cigarette	E-cigarette containing zero nicotine e-liquid

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-07-15
• Completion: 2024-08-12
• First posted: 2019-08-15
• Last updated: 2025-09-11
• Results posted: 2025-09-11

Locations

1 site across 1 country: United States