Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

Penn State Health

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: Reduced Nicotine Content Cigarettes; Drug: Same Nicotine Content Cigarettes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01928719

P50DA036107-01 (U.S. NIH Grant/Contract)

43804UG-P1

Details and patient eligibility

About

The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status

Full description

To address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in low socioeconomic smokers, we will randomize smokers to either an Reduced Nicotine Content group with a gradual step-wise reduction in nicotine from 11 mg to 0.2 mg per cigarette in five 3-wk stages, or a control group with nicotine content similar to their preferred usual brand of cigarettes.

Overall, we hypothesize that low socioeconomic smokers who switch to progressively lower nicotine cigarettes will initially alter their smoking behavior to compensate for lower nicotine until cigarette nicotine yields become so low that complete compensation becomes too difficult. At that point, smokers will either drop-out or continue to smoke the reduced nicotine content cigarettes but with incomplete compensatory behaviors.

Enrollment: 280 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18-65
• Less than 16 years of education
• Able to understand, and sign consent
• Smoke >4 cigarettes/day for at least a year
• No quit attempt in prior 1 month and not planning to quit smoking within next 6 months
• Plan to live in local area for next 8 months
• Able to read and write in English
• Women not pregnant and taking steps to avoid pregnancy

Exclusion criteria

• College graduate
• Use of psychotropic drugs
• Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data
• Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months
• Currently pregnant or nursing
• Uncontrolled serious psychotic illness or substance abuse
• History of difficulties providing blood samples-fainting, poor veins, anxiety

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups, including a placebo group

Reduced Nicotine Content Cigarettes

Experimental group

Description:

the experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette.

Treatment:

Drug: Reduced Nicotine Content Cigarettes

Same Nicotine Content Cigarettes

Placebo Comparator group

Description:

The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)

Treatment:

Drug: Same Nicotine Content Cigarettes