COMPUTERIZED DOSING OF TEEN NICOTINE GUM USE

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$175,007.00
Award Year:
2002
Program:
SBIR
Phase:
Phase I
Contract:
1R43DA013849-01A2
Agency Tracking Number:
DA013849
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
PERSONAL IMPROVEMENT COMPUTER SYSTEMS
PERSONAL IMPROVEMNT COMPUTER SYS, 12007 SUNRISE VALLEY DR, STE 480, RESTON, VA, 22091
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
WILLIAM RILEY
(703) 758-1400
BRILEY@LIFESIGNUSA.COM
Business Contact:
ALBERT BEHAR
(703) 758-1400
ALBEHAR@LIFESIGN.COM
Research Institution:
n/a
Abstract
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.

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