The passage of the Family Smoking Prevention and Tobacco Control Act in 2009 provided the FDA with regulatory authority to reduce the nicotine content of cigarettes to levels that would decrease the addictive potential of cigarettes. Although such a regulatory strategy would likely have a significant positive impact on public health, such policy may have unintended consequences for certain vulnerable populations, including those with psychiatric comorbidity. Individuals with Attention Deficit Hyperactivity Disorder (ADHD) are more likely to smoke cigarettes than the general population, start smoking at a younger age, progress to regular use and dependence more quickly, smoke more and are more dependent, experience more severe withdrawal symptoms during acute abstinence, and have a harder time quitting. Given their increased risk across a range of smoking outcomes, smokers with ADHD may exhibit clinical deterioration or consume other tobacco products if the nicotine content of cigarettes were substantially altered. The overall goal of the proposed project is to examine the effects of very low nicotine content (VLNC) cigarettes on smoking behavior and clinical functioning in young adult smokers with ADHD. We will capitalize on existing expertise, infrastructure, and collaborative projects in this 2-site trial to recruit a large cohort of regula smokers with ADHD. Following careful characterization of baseline smoking, participants will be randomized (1:1) to smoke either regular nicotine content (0.8 mg/cig) cigarettes or VLNC cigarettes (0.05 mg/cig) for a period of 6 weeks and we will measure a range of smoking and ADHD-related outcomes.

Public Health Relevance

The FDA, under the Family Smoking Prevention and Tobacco Control Act, has the authority to reduce the content of nicotine in cigarettes if appropriate for improving population health. However, very little evidence exists for understanding the effects of nicotine reduction, particularly among special populations, including individuals with mental illness. The proposed project will evaluate the effects of reduced nicotine content cigarettes on smoking behavior in individuals with ADHD.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD083404-02
Application #
9109650
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Lee, Karen
Project Start
2015-07-13
Project End
2020-06-30
Budget Start
2016-07-01
Budget End
2017-06-30
Support Year
2
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Duke University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705