Very Low-Nicotine Cigarettes in Smokers With SUD
Very Low-Nicotine Cigarettes in Smokers With SUD
The purpose of this study is to determine the efficacy, acceptability and unintended
 consequences of very low nicotine content cigarettes (VLNCC) in smokers with current or past
 year substance use disorders (SUD). The primary aim of this study is to determine whether 6
 weeks of VLNCC compared to normal nicotine content cigarettes (NNCC) will result in more
 smoking cessation over 6 months and reduce cigarette use, cotinine, and biomarkers of
 toxicity. We will also assess the effects of VLNCC versus NNCC cigarettes on frequency of
 substance use and substance cravings (drugs and alcohol) because this is relevant to the
 safety of these products among smokers with SUD. Secondary aims are to study effects on
 cigarette craving, nicotine withdrawal and dependence, and depressed mood. Methods: Random
 assignment to VLNCC versus NNCC of up to 312 smokers with SUD will be balanced by gender,
 degree of tobacco dependence, and recent drug and alcohol use. All smokers will be provided
 with smoking counseling. Assessments over 6 months will assess effects both during the 6
 weeks of using research cigarettes and 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.
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