Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder

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.

Inclusion Criteria:

- Ages 21-65;

- Smokes ≥ 10 cigarettes/day for ≥ 2 years;

- Has no immediate plans to quit drinking or smoking; and

- Sufficient understanding of informed consent form and study procedures.

Exclusion Criteria:

- Has or is at-risk of serious alcohol-related consequences, defined as any of the
following:

1. Meets DSM-5 criteria for current alcohol use disorder with the presence of 6 or
more symptoms (i.e., current severity of severe)

2. Has a Clinical Institute Withdrawal Assessment scale score of ≥8,

3. Self-report of history of seizures, delirium, or hallucinations during alcohol
withdrawal;

4. Self-report of drinking to avoid withdrawal symptoms, or

5. Self-report of a history of alcohol withdrawal treatment.

- Women if pregnant, lactating, or not using a reliable form of birth control;

- Has current serious psychiatric disorder;

- Has DSM-5 current severe substance use disorder, other than nicotine;

- Has current use of smokeless tobacco, pipes, cigars, e-cigarettes, or nicotine
replacement products;

- Displays clinically evident intoxication on any study visit, confirmed by breathalyzer
test (breath alcohol level (BAL)>0.02 mg%);

- Has difficulties with blood draws or poor venous access; or

- Has significant smoking-related disease (by history).