Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder
Condition: Alcohol Drinking; Cigarette Smoking Toxicity
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed research will investigate whether smokers with vs. without current at-risk
      alcohol drinking (ARD) respond to reduced nicotine cigarettes by increasing their alcohol
      consumption or smoke exposure, thereby diminishing the hypothesized public health benefit of
      these new products.
    

Detailed description: 
      The current proposal examines response to two RNCs, one with low nicotine content (RNC Low;
      0.03mg) and one with moderate nicotine content (RNC Moderate; 0.8mg) in daily smokers with
      and without ARD. Participants (N = 70) will attend a total of five visits to the laboratory.
      The first visit will be to classify participants as either ARD (n = 35) or Non ARD (n = 35)
      and gather baseline data. Participants will be assigned to undergo two experimental
      conditions (i.e., exclusive smoking of RNC Low or Moderate in their home environment for 7
      days) in a double-blind, randomized, crossover design. The two experimental conditions will
      be separated by a 7-day period of return to smoking of participants' own brand of cigarette.
      On the first and last day of each of the two experimental conditions, participants will smoke
      the assigned RNC in the laboratory, and data on toxicant exposure (i.e., boost in exhaled
      carbon monoxide and plasma nicotine and cotinine; solanesol from smoked cigarette butts),
      subjective acceptability (i.e., subjective response; risk perceptions; relative reinforcing
      efficacy); and smoking compensation (i.e., smoking topography measures) related to the smoked
      RNC will be collected. During each 7-day period of exposure to the RNCs, participants will
      provide daily data on alcohol and nicotine use, nicotine withdrawal, smoking urge, and
      alcohol urge via telephone-based Interactive Voice Response technology. The strength of our
      study design is that we can evaluate both between-group (i.e., ARD vs. Non ARD) and
      within-person (i.e., RNC Low vs. Moderate) differences in response to RNCs and, furthermore,
      can examine whether increased nicotine withdrawal, smoking urge, and alcohol urge mediate the
      relation between decreased nicotine exposure and alcohol consumption. Results from this study
      will show what mechanisms underlying drinking and smoking may need to be addressed in future
      integrated interventions for both problems and will immediately inform the practical
      implementation of market-wide reductions in cigarette nicotine content among smokers with
      ARD.
    

Intervention name(s): Reduced nicotine cigarettes
Intervention type(s): Drug
Intervention description(s): Participants will be assigned to undergo two experimental conditions (i.e., exclusive smoking of RNC Low or Moderate in their home environment for 7 days) in a double-blind, randomized, crossover design. The two experimental conditions will be separated by a 7-day period of return to smoking of participants' own brand of cigarette.
Other intervention name(s): Nicotine research cigarettes
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: alcohol; drinking; smoking; cigarette; nicotine