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COMPUTERIZED DOSING OF TEEN NICOTINE GUM USE

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43DA013849-01A2
Agency Tracking Number: DA013849
Amount: $175,007.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2002
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
PERSONAL IMPROVEMNT COMPUTER SYS 12007 SUNRISE VALLEY DR, STE 480
RESTON, VA 22091
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 WILLIAM RILEY
 (703) 758-1400
 BRILEY@LIFESIGNUSA.COM
Business Contact
 ALBERT BEHAR
Phone: (703) 758-1400
Email: 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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