Version 2.1.1.0

Abstract

Grant Number:	3R44DA013062-03S1
PI Name:	RILEY, WILLIAM T.
PI Email:	briley@lifesign.com
PI Title:	DIRECTOR OF RESEARCH
Project Title:	Computerized Scheduling of Nicotine Nasal Spray

Abstract: DESCRIPTION (provided by applicant): The overall goal of this project is to develop and evaluate a computerized dosing program to facilitate the effective use of nicotine nasal spray for smoking cessation. During Phase I, a prototype program was developed that determined an appropriate nasal spray dosing schedule based on a one week baseline smoking record, prompts stable dosing for two weeks upon cessation of smoking, and then gradually reduced nasal spray use until nicotine cessation was achieved. The program was then compared to ad lib dosing of nasal spray in a randomized trial of 100 smokers, which provided support for the feasibility of this product. During Phase II, we will modify the prototype LS-NS based on the results of the Phase I results and conduct a randomly controlled trial of 425 smokers with one year follow-up comparing computerized scheduled dosing to ad lib dosing on nicotine nasal spray. Subjects will be evaluated at baseline, a 10 week post-test, and at six and 12-month follow-ups. Primary outcome variables will be smoking abstinence, latency to relapse, the number of nasal spray doses administered during the initial weeks of treatment, and the percent nicotine abstinent at post-treatment. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

Thesaurus Terms:
computer assisted patient care, computer system design /evaluation, human therapy evaluation, smoking cessation
clinical trial, drug /alcohol abstinence, drug administration rate /duration, inhalation drug administration, longitudinal human study, miniature biomedical equipment, nicotine, relapse /recurrence, substance abuse related behavior
behavioral /social science research tag, human subject, patient oriented research

Institution:	PERSONAL IMPROVEMENT COMPUTER SYSTEMS
	12007 SUNRISE VALLEY DR, STE 480
	RESTON, VA 22091
Fiscal Year:	2003
Department:
Project Start:	25-SEP-1999
Project End:	31-JUL-2003
ICD:	NATIONAL INSTITUTE ON DRUG ABUSE
IRG:	ZRG1

---