# Randomized trial of low nicotine cigarettes plus electronic cigarettes in smokers with a mental health condition

> **NIH NIH R01** · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · 2021 · $448,461

## Abstract

Project Summary/Abstract
 The long term goal of this project is to determine the likely health effects in Smokers with Mental Health
Conditions (SMHC) of a rule requiring very low nicotine content in cigarettes, in conjunction with availability of
nicotine-containing electronic cigarettes (ecigs). This will be tested in a rigorous randomized controlled trial
design. We plan to use a comprehensive set of measures of proven validity and reproducibility, including
toxicant exposure (urinary NNAL, exhaled CO), addiction (FTND) and mental health (Kessler K6) to assess
these effects.
 This is a prospective parallel-group randomized double-blind, 2-by-2 controlled trial in which 240
current smokers with mental health conditions will be randomized to one of 4 groups: 1) normal nicotine
content cigarettes (11mg nicotine content per cigarette, NNCs) and 15mg/mL nicotine ecigs; 2) NNCs and zero
mg/mL nicotine ecigs; 3) Very low nicotine content cigarettes (0.2mg nicotine/cigarette, VLNCs) and 15mg/mL
nicotine ecigs 4) VLNCs and zero mg/mL nicotine ecigs. They will be followed for 16 weeks on study products
and then another 4 weeks thereafter. Participants will first complete a preliminary phone eligibility assessment
and an in-person screening. Next, an in person assessment visit will be scheduled to complete informed
consent and determine eligibility. After 1 week of smoking their own brand of cigarettes, participants will
receive 2 weeks of the NNC cigarettes and be asked to keep a cigarette log.
 Eligible participants will be randomly assigned to one of the four groups using a computer algorithm
developed by study statisticians and overseen by the Penn State Investigational Drug Pharmacy. The
Pharmacy will also prepare blinded cigarettes and e-cig devices. All study products will be relabeled to ensure
participants and staff are blinded to the nicotine content. At the end of the 16-week randomization phase,
participants will come to their last visit, receive encouragement to quit all tobacco products and be given
resources in the community where they can receive smoking cessation counseling. Participants will be asked
to provide information about their intentions for ongoing tobacco product use or cessation and will be followed
up 4 weeks later to assess these outcomes. Those claiming to be no longer using combustible tobacco
products will be visited to verify with a measure of exhaled CO.

## Key facts

- **NIH application ID:** 10229461
- **Project number:** 5R01DA048428-03
- **Recipient organization:** PENNSYLVANIA STATE UNIV HERSHEY MED CTR
- **Principal Investigator:** JONATHAN FOULDS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $448,461
- **Award type:** 5
- **Project period:** 2019-08-01 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10229461

## Citation

> US National Institutes of Health, RePORTER application 10229461, Randomized trial of low nicotine cigarettes plus electronic cigarettes in smokers with a mental health condition (5R01DA048428-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10229461. Licensed CC0.

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