Clinical Trial: Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder

Brief Summary: The proposed research will investigate whether smokers with vs. without current alcohol use disorder (AUD) 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 Summary: 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 AUD. Participants (N = 70) will attend a total of five visits to the laboratory. The first visit will be to classify participants as either AUD (n = 35) or Non AUD (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., AUD vs. Non AUD) 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
Sponsor: Battelle Memorial Institute

Current Primary Outcome: Alcohol drinks per day [ Time Frame: 7 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Toxicant exposure [ Time Frame: 7 days ]
    (1) boost in (a) exhaled carbon monoxide, (b) plasma nicotine, and (c) plasma cotinine, and (2) solanesol after laboratory smoking
  • Subjective acceptability [ Time Frame: 7 days ]
    subjective response
  • Smoking compensation [ Time Frame: 7 days ]
    number of cigarettes per day during each 7-day period


Original Secondary Outcome: Same as current

Information By: Battelle Memorial Institute

Dates:
Date Received: December 7, 2016
Date Started: March 2017
Date Completion: November 2019
Last Updated: December 8, 2016
Last Verified: December 2016