Very-Low Nicotine Cigarettes and Non-Daily Smokers

Saul Shiffman

Status: Completed

Conditions: Smoking

Treatments: Drug: Very low nicotine content cigarettes; Drug: Normal nicotine content cigarettes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02228824

3P30CA047904-25S4

Details and patient eligibility

About

The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA) on how best to regulate tobacco products in the future, with the goal of improving public health.

Full description

The overall goal of the study is to assess the effects of switching to Very-Low-Nicotine-Content cigarettes (VLNCCs) among non-daily, or intermittent smokers (ITS). This is a two-arm randomized study with an own-cigarette baseline control. After a 2-week baseline period smoking their own cigarettes, 455 ITS will be randomized (double-blind) for 10 weeks to smoke experimental cigarettes, either: (a) normal nicotine content cigarettes (NNCCs; 0.8 mg) or (b) VLNCCs (0.07 mg), each matched to menthol status of subjects' preferred brand. ITS are more likely to be African-American (AA) smokers; thus AA smokers will be oversampled (to one third of the total sample). Change in cigarette consumption is the primary end-point, and biomarkers of smoke exposure and measures of smoking intensity are also assessed.

Enrollment: 312 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18 years or older, and smoking cigarettes for at least 3 years
• smoking, on average, 4-27 days per month
• smoking at current rate for at least the previous 3 months
• willingness to try novel cigarettes

Exclusion criteria

• active plans to quit or actively seeking smoking cessation treatment in the next 3 months
• severe psychiatric disorders that may interfere with study procedures
• current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report
• exclusive use of roll-your-own cigarettes (since the study uses manufactured cigarettes)
• [for female participants] being pregnant or breastfeeding, or planning to become pregnant, by self-report
• current use of medications such as Chantix (varenicline), Zyban, Wellbutrin, or bupropion for any purpose, including stopping smoking
• occurrence of heart attack, stroke, or angina in the past 3 months

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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312 participants in 2 patient groups

Very low nicotine content cigarettes

Experimental group

Treatment:

Drug: Very low nicotine content cigarettes

Normal nicotine content cigarettes

Active Comparator group

Treatment:

Drug: Normal nicotine content cigarettes