Very Low-Nicotine Cigarettes in Smokers With SUD

The 2009 passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) gave the
Food and Drug Administration (FDA) the authority to reduce levels of nicotine in cigarettes
if appropriate for public health. This project addresses an area targeted for study by NIH
and the FDA to assess the impact of products with reduced toxicity on tobacco use behaviors.
Very-low nicotine content cigarettes (VLNCC) have been shown in some studies with smokers
from the general population to reduce craving and withdrawal for tobacco relative to
abstinence with little or no compensatory smoking, suggesting that a mandated reduction in
the nicotine yield of cigarettes could substantially reduce smoking rates. This may be a
particularly effective method of reducing smoking and smoking-related disease in special
populations that have very high rates of tobacco dependence, such as people with substance
use disorders (SUD). However, the consequences of this policy for smokers with SUD have not
been investigated, and a call has gone out for studies of the safety of these products with
vulnerable populations such as these. The purpose of this study is to determine the
efficacy, acceptability and unintended consequences of VLNCC in smokers with SUD (current or
past year) currently abstinent from hard drugs. The primary aims are to determine whether
VLNCC will increase smoking cessation and reduce cigarette use, cotinine, and biomarkers of
toxicity in smokers with SUD relative to baseline and to those randomized to a normal
nicotine content cigarette (NNCC), and to determine any unintended effects of VLNCC on
substance use and cravings to use substances so as to investigate safety. Secondary aims are
to study effects on cigarette craving and nicotine withdrawal and dependence (mechanisms),
and state depression (safety). A 2-group between-group by pre-post design will compare 6
weeks of VLNCC to NNCC; all smokers will also be provided with smoking counseling. Follow-up
over 6 months will assess effects after return to usual cigarettes. The importance is in
determining the viability and safety of this public health strategy in terms of effects on
both smoking and other substance use in a highly addicted population, which is essential to
determine before the FDA implements this policy.

Inclusion Criteria::

- Diagnostic and Statistical Manual-5 criteria for current or past year substance use
disorder

- smoke 10+ cigarettes/day for past 6 months

- zero breath alcohol, negative urine drug tests and a self-report of no drug use in
the past 30 days on day of informed consent

- score of 4-8 on the Contemplation Ladder (individuals interested in quitting smoking
someday and/or have thought about quitting)

Exclusion Criteria:

- active psychosis as evidenced by hallucinations or delusions

- actively quitting smoking or current use of any nicotine replacement or other smoking
cessation treatment

- medication contraindications for smoking cessation (smoking cessation may change the
bioavailability of antipsychotics, warfarin, theophylline and insulin)

- other medications that could affect smoking (naltrexone, buprenorphine, acamprosate,
anti-seizure medications, disulfiram)

- if on psychotropic medications, not stabilized on psychotropic medications (i.e.,
anti-depressant, anti-anxiety or anti-manic medications changed within past 4 weeks)

- inability to understand informed consent in a test (true-false questions) on the key
elements of the consent form