You are here
COMPUTERIZED DOSING OF TEEN NICOTINE GUM USE
Phone: (703) 758-1400
Email: BRILEY@LIFESIGNUSA.COM
Phone: (703) 758-1400
Email: ALBEHAR@LIFESIGN.COM
We propose to develop a hand-held computer program to determine initial dosing and eventual tapering of nicotine gum use which targets and addresses the unique needs and smoking patterns of adolescent
smokers. The product (NGDDD) will determine an initial dosing of gum use for
adolescent smokers based on their baseline smoking behavior and then provide a
scheduled dosing, dispensing and eventual gradual taper of gum use to promote
appropriate initial nicotine gum use and minimize abuse liability. Following
development and pilot testing, the NGDDD will be evaluated in a 6-week clinical
trial with 40 teenage smokers. All subjects will receive nicotine gum and the
NGDDD prototype device to use for a six-week period. Subjects will visit the
clinic weekly to assess progress, gum use, side effects, and to receive their
next week's supply of nicotine gum. The primary outcome measures for the
feasibility study will be initial gum use, compliance with the dosing schedule,
gum use at the end of the study and smoking cessation rates. Various program
use variables also will be assessed to guide Phase II modifications.
* Information listed above is at the time of submission. *