Computerized Scheduling of Nicotine Nasal Spray

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 2R44DA013062-02
Amount: $446,068.00
Phase: Phase II
Program: SBIR
Awards Year: 2001
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
12007 SUNRISE VALLEY DR, STE 480, RESTON, VA, 22091
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 WILLIAM RILEY
 () -
Business Contact
Phone: (703) 758-1400
Email: ALBEHAR@LIFESIGN.COM
Research Institution
N/A
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

* Information listed above is at the time of submission. *

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