Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02990455 |
Other study ID # |
BMI-202181 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 1
|
First received |
|
Last updated |
|
Start date |
November 14, 2017 |
Est. completion date |
April 21, 2021 |
Study information
Verified date |
September 2021 |
Source |
Battelle Memorial Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.