QuitKey Research Studies
Edited by Dr. Jami Obermayer, Ph.D., Director of Research PICS, Inc.
and evaluation of the QuitKey approach was funded, in part, by Small Business Innovation
Research (SBIR) grants awarded by the National Institute on Drug Abuse (NIDA) and the
National Cancer Institute (NCI). Here are some of the reports and published articles
associated with these studies.
Reviews and Citations, Recent Presentations at Scientific
Riley, W.T., Jerome, A., Behar, A., & Weil, J. (2002). Computer and manual self-help behavioral strategies for smoking reduction: Initial feasibility and one year follow-up. Nicotine and Tobacco Research, 4 (supp 2), S183-S188.
This study sought to test the feasibility of two self-help behavioral interventions to reduce and maintain a 50% reduction in those unable or unwilling to quit, and to evaluate the impact of smoking reduction on subsequent quit attempts. Ninety-three smokers who desired to reduce rather than quit smoking were entered in the study and randomly assigned to either computerized scheduled gradual reduction (CSGR) or to a manual-based selective elimination reduction (SER). Both groups produced significant reductions in smoking, approximately 10 cigarettes per day, during the seven week treatment phase which were maintained over one year. Except for significantly greater mean percent reductions in smoking from pre- to post-treatment (37% for CSGR, 20% for SER) and a greater percentage of subjects meeting the 50% reduction goal (30% for CSGR, 16% for SER) which approached significance, the CSGR intervention produced reductions in smoking comparable to the SER intervention, particularly at the 6 and 12 month follow-up. Although subjects with a current desire for smoking cessation were excluded from this study, one third of subjects reported a 24 hr. quit attempt for the year following study initiation, and 8.6% of subjects met seven-day point-prevalence criteria for abstinence (CO validated) at the 12 month follow-up. The results of this study lend support to the feasibility of self-help behavioral interventions to produce sustained reductions in smoking rates without apparent negative impact on subsequent quit attempts.
Riley, W., Jerome, A., Behar, A., & Zack, S. (2002). Feasibility of computerized scheduled gradual reduction for adolescent smoking cessation. Substance Use & Misuse, 37, 277-285.
The purpose of this project was to modify a smoking cessation program that uses computerized scheduled gradual reduction for use with adolescent smokers and to test the feasibility of this cessation approach in group support and minimal contact modalities. Utilizing a lesson plan approach with high school marketing students in five high schools and student survey feedback, the LifeSign program was modified to be an acceptable smoking cessation program for adolescent smokers. In the first study, 17 adolescent smokers used the modified program with seven associated weekly group support sessions. At the end of treatment, 29% had quit smoking, and over half of those who continued to smoke reduced their smoking rate by 50%. In the second study, the LifeSign for Teens program was evaluated with 18 adolescent smokers in a minimal contact format. At the end of treatment, 17% had quit smoking, and mean smoking rate reductions of 43% were found among those who continued smoking. At 1-year follow-up, all subjects who had quit at posttreatment reported continuous abstinence. The results of these two small trials suggest that a computerized scheduled gradual reduction approach may be an accepted and potentially efficacious approach for smoking cessation among adolescent smokers.
Severson, H. H., Akers, L., Andrews, J. A., Lichtenstein, E., & Jerome, A. (2000). Evaluating two self-help interventions for smokeless tobacco cessation. Addictive Behaviors, 25, 465-470.
The need for effective, low-cost self-help treatment methods for smokeless tobacco (ST) addiction becomes more evident as rates of product use and associated morbidities increase. This study evaluated two self-help methods for ST cessation. One hundred ninety-eight ST users were randomly assigned into two conditions: half received LifeSign, a credit-card sized computer designed for gradual ST cessation, and half received the Enough Snuff self-help manual and a video. Subjects in both conditions received telephone support for their quit effort. The study was conducted entirely through phone and mail, allowing the delivery of the intervention to both rural and urban users. Self-reported rates of sustained abstinence (no tobacco use at two months and six months) were 24.5% for the manual/video condition, and 18.4% for the LifeSign condition.
Jerome, A., Fiero, P. L., & Behar, A. (2000). Computerized scheduled gradual reduction for smokeless tobacco cessation: Development and preliminary evaluation of a self-help program. Computers in Human Behavior, 16, 493-505.
The paper chronicles the development and feasibility testing of a computerized scheduled gradual reduction program for smokeless tobacco cessation. During Study 1, the LifeSign smoking cessation computer was adapted for use with smokeless tobacco by pairing it with an electronic timer. The computer recorded frequency of dips during a baseline phase and prompted for tobacco use during a gradual reduction phase. The timer was used to track the length of dips during baseline and to hold them to a fixed length during the reduction phase. Abstinence rates among 60 male daily smokeless tobacco users who received the program were 29% at 3-month follow-up (biochemically validated) and 19% at 12-month follow-up. Self-reported changes in topography of tobacco use were consistent with the scheduled reduction protocol. Study 2 evaluated a prototype computer that tracked both frequency and duration of dips during baseline and gradually reduced both parameters during the reduction phase. Among 19 subjects who received the program, self-reported abstinence was 56% at end of treatment and 11% at 12-month follow-up. Results of these two studies demonstrate the feasibility of computerized scheduled gradual reduction for smokeless tobacco cessation and provide a basis for further product development.
Jerome, A., Perrone, R., & Kalfus, G. (1992). Computer-assisted smoking treatment: A controlled evaluation and long-term follow-up. Journal of Advancement in Medicine, 5, 29-41.
The present study provided a controlled outcome evaluation and long-term follow-up assessment of a computer-assisted smoking treatment (CAST), implemented by a credit card-sized, fully dedicated microcomputer. Seventy-one smokers were randomly assigned to one of three groups: 1) CAST, 2) CAST plus therapist assistance, or 3) waitlist control. Results indicated that subjects complied with the computer treatment protocol and that daily cigarette consumption and carbon monoxide levels decreased across treatment weeks in both CAST groups. At 18-month follow-up, 24% of subjects in the CAST group and 36% of subjects in the CAST plus therapist assistance group were abstinent. These findings are comparable to outcomes reported for many clinic-based interventions and thereby suggest that this CAST program can be utilized effectively in either a self-help or therapist-assisted format.
Prue, D. M., Riley, A., W., Orlandi, M. A., & Jerome,
A. (1990). Development of a computer-assisted smoking cessation program: A preliminary
report. Journal of Advancement in Medicine, 3, 131-139.
The effectiveness of a self-help smoking cessation program
implemented by a hand-held micro computer was evaluated with 77 smokers. The computer
implements a gradual rate reduction protocol that targets both physiological dependence on
nicotine and conditioned stimuli that may elicit smoking. One-year post treatment
abstinence rates for two samples of smokers were 18.5% and 22%. The results of this study
suggest that a computer-based self-help program may meet the needs of health care
providers for an easily administered, effective tool for assisting patients with smoking
Institute of Medicine (2001). Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction. Washington, DC. National Academy Press.
"More recent exploration of reduced smoking has used computerized devices to gradually wean smokers from cigarettes as a means to achieve cessation. One computerized program, LifeSign Computer Assisted Smoking Program, involves a scheduled reduction by increasing the interval between cigarettes and informing individuals when to smoke. The scheduled time-interval approach seems the most promising of the behavioral treatment methods based on studies by Ciniciripini and colleagues (Ciniciripini et al., 1995 and 1997) compared to abrupt discontinuation or nonscheduled reduction of cigarettes. This behavioral method systematically reduces the level of nicotine exposure, disrupts habitual smoking patterns, and gives smokers the opportunity to develop new behaviors or skills in response to cues associated with smoking."
Compliance in Health Care and Research (2001). Edited by Lora Burke and Ira Ockene, American Heart Association Monograph Series, Futura Publishing, Armonk, NY
"The LifeSign (PICS, Inc., Reston, VA) is a compact electronic recording device approximately the size of a credit card and one-half inch thick. The individual records each time a tobacco product is used by pushing one button."
"The primary advantage of using electronic recording devices is that data are collected in real time, at the time of the symptoms or behavioral performance."
Lora Burke, PhD, MPH, RN
Chapter 8, Electronic Measurement
SRNT Newsletter (Vol 6, No. 1, April, 2000)
"Robin Corelli and Karen Hudmon, in collaboration with the Pharmacy Partnership of the California Medical Association Foundation, have orchestrated a project whereby pharmacy faculty members and tobacco researchers have designed a six-hour, comprehensive, tobacco curriculum program for pharmacy students."
"The three hour workshop component includes role playing with case studies and hands-on experience with pharmaceutical aids for smoking cessation and the LifeSign hand-held computer for scheduled, gradual reduction of smoking."
The Behavior Therapist (Vol. 13, No. 3, March, 1990)
"I was very impressed with the program. It clearly incorporates sound behavioral principles both the computerized cessation program itself, and in the supporting materials provided in the manual."
"Existing data, most from small N studies, suggest that the program may be at least as effective as other self-help smoking reduction programs, and perhaps more so."
"The bland paragraphs above dont communicate my intense excitement about the program. Whatever the data ultimately suggest regarding the effectiveness of the program in its current state, this is an important development in behavioral self-help programming because of the potential that this technology portends."
"I think LifeSign opens tremendously important doors to research and applications in self-help behavioral programs."
Robert K. Klepac, Ph.D.
Wilford Hall Medical Center
William T. Riley, PH.D., Bradford W. Applegate, PH.D., Allison Sowell , M.S.; PICS, Inc. (2004) A Comparison Of Computer-Assisted Scheduled Gradual Reduction VS. Self Help in Unmotivated Smokers.
Despite recent advances in treatment, many tobacco users are unwilling or unable to quit. Harm reduction strategies have recently been proposed as an alternative to current treatment approaches. The present data examines the efficacy of a computerized scheduled reduction program (SGR) as compared to a self-help manual (SH).
Participants who smoked > 15 cpd and had no intentions of quitting in the next 30 days (N = 268) were randomly assigned to SGR or SH conditions. The SGR condition monitored use for 7 days, followed by SGR to achieve a 50% reduction. SH participants received information on reducing use. Smoking rates and associated variables were measured at baseline, 9 weeks, and 6 months.
Participants smoked 27 cpd and were 46 years old, on average. The sample was 50% male and 59% Caucasian. There were no significant differences between conditions at baseline. Treatment completion was 74% at 9 weeks and 61% at 6 months.
Repeated measures MANOVA indicated both main and interaction effects between SGR and SH conditions, (both p’s < .05). SGR participants reduced intake from 27 to 18.5 cpd at 9 weeks, compared to a reduction of 27 to 22 CPD in the SH condition. Effects diminished at 6 months as SGR participants maintained their rates and SH participants reduced smoking to comparable rates. Secondary analyses revealed that a greater proportion of SGR participants achieved > 50% reduction in smoking than SH participants. Changes in health status and motivation to quit were associated with reducing intake, but not sufficiently to justify reduction as a harm reduction approach.
William T. Riley, PH.D., Melissa Pici, B.A.,
Valerie L. Forman, Ph.D., Albert Behar, M.S.; PICS, Inc. (2003) Computerized
Dosing of Nicotine Inhalers: Effects on Use and Quit Rates. Paper
presented at the 9th Annual Meeting of the Society For Research on Nicotine and
Tobacco. New Orleans, LA.
The purpose of this study was to develop and evaluate a
computerized program to encourage adequate dosing of nicotine inhalers. Two handheld
computerized dosing/prompting programs were developed. Both utilized a one week
smoking baseline to determmine the intitial inhaler prompting schedule but differed in the
length of the stable dosing period prior to tapering use (3 weeks vs. 12 weeks).
These computer prompting programs were compared to an inhaler only condition in a
radomized trial of 462 smokers evaluated at 9 and 18 weeks (1 yr. follow-ups pending).
At 9 weeks, 32% of the computerized dosing groups has been quit for 7 days or
longer (biochemically validated) compared to 20% for the inhaler only condition
(chi-square = 4.69, p < .05). Continuous quit rates at 9 weeks were 21% for the
computerized dosing groups and 11% for the inhaler only group (chi-square = 5.76, p <
.02). At 18 weeks, 26% of the computerized dosing groups and 18% of the inhaler only
group met point prevalence criteria. Continuous quit rates at 18 weeks were not
significantly different (14% vs. 9%). Those in the computerized dosing conditions
also reported higher doses per day in the first week of use than those in the inhaler only
condition (9 vs. 7; t= 3.34, p < .001). No signficant differences were found
between the two computerized programs. The results of this study indicate that
computerized prompting increases initial nicotine inhaler dosing and produces higher
initial quit rates than typical inhaler administration.
Valerie L. Forman, Ph.D., Melissa Pici, B.A.,
William T. Riley, Ph.D., PICS, Inc. (2003) Impact of September 11th
Tradegy on Smoking and Relapse Rates. Paper presented at the 9th Annual Meeting
of the Society For Research on Nicotine and Tobacco. New Orleans, LA.
The September 11, 2001 terrorist attacks on the United
States had widespread behavioral and emotional impacts. Although one study found an
increase in smoking rates amoung Manhattan, New York residents following the tradegy
(Vlahov et al., 2002), no studies have examined the effect on individuals trying to quit
smoking at the time of the attacks. Local media in the Washington, D.C. area was
used to recruit 462 smokers into a study comparing the effect of computerized-scheduled
reduction to ad-lib dosing of nicotine inhalers on quit rates. The terrorist attack
was temporarily associated with various stages of the study protocol. Mean smoking
rates the week before September 11th were slightly lower than mean smoking rates the week
after September 11th (11.8 cigarettes per day versus 12.6 cigarettes per day
respectively). Higher ratings on the Impact of Events (IES) scale, completed
retrospectively after all subjects had completed the 18-week evaluation, were associated
with increased cigarette use following the terrorist attacks (Pearson's r=0.25 p<0.01).
Among the 303 participants who completed smoking diaries, 43.9% did not change
smoking rates, 23.1% decreased smoking, and 34.3% increased smoking the week following the
tradegy. Thirteen of the 82 subjects who had quit prior to September 11th relapsed
in the week following the attacks (15.9%); IES scores among those who relapsed were
moderately higher than subjects who remained quit (36.9 versus 29.8, respectively).
Although the terrorist attacks were associated with increases in smoking and relapse
rates, the effect was relatively small and not significant. Greater perceived impact
of the events of September 11th, however, predicted moderate increases in smoking and
Obermayer, J., Riley, B., Asif, O., Jean-Mary, J. (2003). College smoking cessation using wireless devices. Poster presented at the 2004 Society of Behavioral Medicine 25th Anniversary Annual Meeting & Scientific Sessions on March 24-27, Baltimore Marriott Waterfront Hotel, Baltimore, Maryland.
Objective: The purpose of this project was to
develop and test the feasibility of a smoking cessation program delivered in the form of
text messages via mobile phones.
Methodology: The usability of this prototype
was assessed in a sample of college students from local colleges and universities.
Forty-six subjects (54% female, 46% male; 72% White, 15% Asian, 7% African American, and 6%
Other) participated in and completed the 6-week assessment trial. Subjects registered on
the study website to personalize and initialize their smoking cessation program. This
allowed subjects to create a quitting plan, indicate situations and times when they were
at high risk for smoking, and input and track their progress towards quitting. Pre-test
and post-test measures included cigarette logs, nicotine dependence scale, smoking and
quitting documentation questionnaire, and a program use questionnaire.
Results: During this study period, 20 subjects (43%)
successfully completed a 24-hour quit attempt. At the end of the six-week study period,
there were 10 subjects (22%) who met the 7-day point prevalence criterion for quitting.
Among subjects who had not quit, cigarette logs and nicotine dependence scale scores
indicated that these subjects substantially reduced their mean cigarette counts of 77
cigarettes/week to 32 cigarettes/week (t = 5.34, p < .001). These
subjects also experienced lowered (-0.37 to 1, t = 5.4, p < .001)
nicotine dependence as measured by the Nicotine Dependence Syndrome Scale (NDSS). All of
the subjects rated the program positively on usability, comparison to other methods tried,
and overall satisfaction.
Significance: The results of this initial study
trial indicates that the WICS program produces high quit rates in comparison to the
overall 10% quit rate for self-help smoking cessation programs, as well as resulting in
positive outcomes for non-abstinent subjects. Smoking on college campuses has increased
substantially in the last decade, yet programs have not targeted these smokers who have
unique patterns and causes of smoking. College students are early adopters of
communications technologies and may, therefore, readily adopt a smoking cessation program
delivered via these technologies.