Very Low-Nicotine Cigarettes in Smokers With SUD
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nicotine; behavioral counseling for smoking cessation
Intervention type(s): Drug; Behavioral
Intervention description(s): Brief session of Brief advice. Assess smoking and provide assistance with quitting via coping skills.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tobacco smoking; smoking cessation; nicotine dependence; tobacco use disorder