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Abstract

Abstract: DESCRIPTION (provided by applicant): 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.

Thesaurus Terms:
computer assisted patient care, computer system design /evaluation, dosage, drug screening /evaluation, human therapy evaluation, nicotine replacement, smoking cessation, tobacco abuse
adolescence (12-20), clinical trial, computer program /software, substance abuse related behavior, tobacco abuse prevention
clinical research, human subject, patient oriented research

Institution:	PERSONAL IMPROVEMENT COMPUTER SYSTEMS
	12007 SUNRISE VALLEY DR, STE 480
	RESTON, VA 22091
Fiscal Year:	2002
Department:
Project Start:	15-SEP-2002
Project End:	31-AUG-2003
ICD:	NATIONAL INSTITUTE ON DRUG ABUSE
IRG:	ZRG1