SBIR-STTR Award

The goal of the research is to improve the effectiveness of smoking cessation treatments and other behavior therapies using an audio or video cassette delivered hypnotherapy program paired with an active electronic trigger-signaling device. The product to be tested is an audio-cassette hypnosis program mated to a programmed electronic wrist device that delivers randomly timed auditory and visual post-hypnotic suggestion triggers for the elimination of smoking behavior in pregnant women. With the patient in a hypnotic state, post-hypnotic suggestions are linked to active auditory and visual signals. With the hypnotic state terminated, the signals are periodically generated by an electronic device worn by the subject. In this manner, the suggested behavior is reliably triggered without need for human intervention. The research is intended to show that hypnosis paired with automatically signaled post-hypnotic suggestion triggers will reduce smoking behavior more effectively than hypnosis alone or no intervention. Our long term objective is to clinically prove an array of products that would be used to modify targeted human behaviors including learned behaviors (e.g., smoking, overeating), motor functions (e.g. bowel and bladder control, blood pressure), and cognitive functions (e.g. academic training, test anxiety). Patent application 07/867.491 entitled "Method of Modifying Human Behavior Using Signal Triggered Post-Hypnotic Suggestion" was allowed on January 24, 1995 and will issue shortly.Proposed commercial application:Commercial applications would be low cost audio, video, and computer generated self-hypnosis programs paired with active electronic trigger-signaling devices to reduce symptoms of smoking, over-eating, general stress, phobias, test anxiety, enuresis, encopresis and others made available to patients through health care providers to be used outside of costly in-person intervention.National Institute of Mental Health (NIMH)

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.

Thesaurus Terms:
behavior modification, biomedical equipment development, human therapy evaluation, hypnosis, nicotine, smoking cessation, suggestion behavioral habituation /sensitization, clinical biomedical equipment, clinical trial, combination therapy, motivation, nicotine patch /gum alternative medicine, audiotape, behavioral /social science research tag, clinical research, female, human pregnant subject, questionnaire