Triggered Suggestion Device to Treat Nicotine-dependence

Period of Performance: 04/01/1999 - 03/31/2001

Unknown

Phase 2 SBIR

Recipient Firm

Progenesis, Inc.
Redmond, WA 98052
Principal Investigator

Abstract

Phase I studied a prototype Triggered Suggestion Device (TSD) to help pregnant subjects reduce their nicotine use. Recent re-evaluation of the phase 1 data shows superior results of the TSD when compared to the control interventions: The TSD group reported a higher score reflecting smoking reduction and method satisfaction than the other groups (p=0.02). The reduction in continue was largest for the TSD group; 35 percent versus 0 percent for the other groups combined (p=0.09). When compared to zero, no reduction, this measure was statistically significant (p=0.03). Study retention was higher in the triggered suggestion group (75 percent) than the combined other groups (58 percent, p=0.09). Phase II is designed to prove that use of the TSD system will result in statistically equivalent or superior long term smoking cessation than use of nicotine patch products. The research will test a pre-production model of a vastly superior TSD. This TSD is a custom designed electronic wristwatch that delivers daily random auditory, visual and tactile triggers during a user programmed time period, and includes two separate self initiated trigger sequences; a Panic mode triggers aversive suggestions when cravings occur, and a Restore mode triggers extra positive suggestions at will. Also, a vastly improved hypnosis CD will be tested. It delivers three programs; a 15- minute one-time introduction program, a daily 20-minute triggered suggestion program, and a daily 5-minute motivational program. Two comparisons are planned; 284 active smokers will be randomized into a TSD group, 284 into a nicotine patch group, and 205 into a placebo non- nicotine patch group. Subjects will be followed at 90 days, 6 months and one year. Three primary endpoints will be: 1. abstinence from nicotine, 2. reported reduction in smoking and questionnaire evaluation of cessation method used , and 3. self-report on the number of cigarettes smoked per day during the week prior to assessment. PROPOSED COMMERCIAL APPLICATION The triggered suggestion habit control system is intended as a medically prescribed and over the counter product to help individuals stop smoking or withdraw from other forms of nicotine dependence. When proven, it will provide a superior alternative to current stop smoking products since it does not introduce potentially harmful chemicals into the body. It will also provide an alternative product to individuals unable to use nicotine replacement therapies,, like pregnant women and teenagers. The intended product will be portable, reusable and private. The cost of such a habit control system will be less than the cost of other commercially available nicotine replacement products.