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Biomedical subjects

Saul Shiffman

Publications and source records attributed to Saul Shiffman.

At least 19 recordsLinked to original sources
PubMed2003

Efficacy of acute administration of nicotine gum in relief of cue-provoked cigarette craving.

RATIONALE: Acute cravings, often provoked by exposure to smoking cues, appear to be important triggers for smoking relapse. Relief of acute craving may therefore be an important step in preventing relapse. OBJECTIVES: This study was undertaken to assess the effectiveness of nicotine gum in relieving acute craving. METHODS: A multi-center, randomized, placebo-controlled study was conducted with smokers ( n=296) who quit by using either active or inactive gum for 3 days. On their third day of abstinence, smokers participated in a laboratory session in which they were exposed to a provocative smoking cue, chewed active or inactive gum, and then rated their craving at 5-min intervals for 35 min. RESULTS: Craving initially decreased in both groups. After 15 min, however, the smokers using active nicotine gum experienced significantly greater craving reductions. CONCLUSIONS: These results suggest that nicotine gum can effectively reduce acute craving following exposure to smoking cues.

Adult↗
PubMed2003

Patient compliance with paper and electronic diaries.

Paper diaries are commonly used in health care and clinical research to assess patient experiences. There is concern that patients do not comply with diary protocols, possibly invalidating the benefit of diary data. Compliance with paper diaries was examined with a paper diary and with an electronic diary that incorporated compliance-enhancing features. Participants were chronic pain patients and they were assigned to use either a paper diary instrumented to track diary use or an electronic diary that time-stamped entries. Participants were instructed to make three pain entries per day at predetermined times for 21 consecutive days. Primary outcome measures were reported vs actual compliance with paper diaries and actual compliance with paper diaries (defined by comparing the written times and the electronically-recorded times of diary use). Actual compliance was recorded by the electronic diary. Participants submitted diary cards corresponding to 90% of assigned times (+/-15 min). However, electronic records indicated that actual compliance was only 11%, indicating a high level of faked compliance. On 32% of all study days the paper diary binder was not opened, yet reported compliance for these days exceeded 90%. For the electronic diary, the actual compliance rate was 94%. In summary, participants with chronic pain enrolled in a study for research were not compliant with paper diaries but were compliant with an electronic diary with enhanced compliance features. The findings call into question the use of paper diaries and suggest that electronic diaries with compliance-enhancing features are a more effective way of collecting diary information.

Adolescent↗
PubMed2003

Intensive momentary reporting of pain with an electronic diary: reactivity, compliance, and patient satisfaction.

Patient self-reports are the primary method for capturing the experience of pain, and diaries are often used to collect patient self-reports. This study was designed to determine if momentary monitoring of pain with an electronic diary affected pain levels over time, if it affected weekly recall of pain, and if daily sampling density affected compliance rates and patients' reactions to the study. Ninety-one patients with chronic pain were randomized into four groups with differing levels of momentary monitoring over 2 weeks. Little support was found for reactivity defined as temporal shifts in pain over the study or as changes in recalled weekly pain due to momentary monitoring. Compliance with the electronic diary protocol was 94% or better, and was not related to sampling density. Patients reported little difficulty with the diary procedures and were not unduly burdened by the protocol.

Adult↗
PubMed2003

Attentional bias predicts outcome in smoking cessation.

Most attempts to quit smoking end in failure, with many quitters relapsing in the first few days. Responses to smoking-related cues may precipitate relapse. A modified emotional Stroop task-which measures the extent to which smoking-related words disrupt performance on a reaction time (RT) task-was used to index the distracting effects of smoking-related cues. Smokers (N = 158) randomized to a high-dose nicotine patch (35 mg) or placebo patch completed the Stroop task on the 1st day of a quit attempt. Smokers using an active patch exhibited less attentional bias, making fewer errors on smoking-related words. Smokers who showed greater attentional bias (slowed RT on the first block of smoking words) were significantly more likely to lapse in the short-term, even when controlling for self-reported urges at the test session. Attentional bias measures may tap an important component of dependence.

Adult↗
PubMed2003

Attentional shifts to smoking cues in smokers.

AIMS: Many theories of addiction assume that responses to drug cues maintain drug use and precipitate relapse. There is evidence that measures derived from experimental cognitive psychology yield important information about cue reactivity. We used a pictorial version of the visual probe task to evaluate: (i) whether minimally deprived smokers attend differentially to smoking cues (attentional bias); (ii) whether this bias is related to self-reported craving and dependence; and (iii) whether it predicted outcome in a subsequent cessation attempt. DESIGN: Participants took part in a structured smoking cessation program. Each participant completed the visual probe task roughly 2 weeks before quitting while non-deprived. SETTING: A research smoking cessation clinic. PARTICIPANTS: 141 heavy smokers seeking treatment for smoking cessation. MEASUREMENTS: The computerized attentional bias measure and self-reported urge were taken in a laboratory session. Participants also monitored their smoking and craving on electronic diaries both when smoking ad libitum and for up to 6 weeks post-cessation. FINDINGS: Participants were faster and more accurate in responding to a visual probe that replaced a smoking picture than to a neutral picture, indicating that they showed attentional bias towards the smoking cues. Attentional bias on the first half of the task correlated with pre-task craving, indicating that the bias may tap motivational processes, but it did not predict outcome in smoking cessation. CONCLUSIONS: The visual probe task can add useful information about attentional responses to drug cues. Further work is required to uncover the theoretical significance and utility of this measure.

Adult↗
PubMed2003

Signaling does not adequately improve diary compliance.

HYPOTHESIS: Compliance with a paper diary protocol would be improved by using auditory signaling. BACKGROUND: Prior research has demonstrated that compliance with the reporting schedule in paper diary protocols is poor. METHODS: Adults with chronic pain (N = 27) were recruited from the community to participate in a 24-day experience sampling protocol of 3 pain assessments per day (10:00 a.m., 4:00 p.m., 8:00 p.m.). Diaries were instrumented to record openings and closings, thereby permitting determination of date and time when the participant could have made diary entries. Participants were signaled with a programmed wristwatch at the onset of each 30-min assessment window. Two compliance windows were defined: -/+ 15 min and -/+ 45 min of the targeted assessment time. RESULTS: Self-reported compliance based on participants' paper diaries was 85% and 91% for the 30- and 90-min windows. Verified compliance was 29% and 39% for the two windows. Signaling produced a significant increment in verified compliance when compared with an identical trial without signaling. A significant eroding of verified compliance was observed across the 3 weeks of the study. CONCLUSIONS: Self-report dating of diary entries may be misleading investigators about compliance with diary protocols. Although auditory signaling enhances compliance, the result is still unsatisfactory.

Adolescent↗
PubMed2002

Efficacy of a nicotine lozenge for smoking cessation.

BACKGROUND: Since nicotine gum was introduced in the 1980s, nicotine replacement therapy has become the most widely used pharmacological smoking cessation treatment. Some smokers prefer acute oral forms, but many smokers reject chewing gum. We tested the safety and efficacy of a new nicotine polacrilex lozenge for smoking cessation. METHODS: Double-blind, placebo-controlled, randomized clinical trial with parallel arms testing 2- and 4-mg nicotine lozenges. Smokers (n = 1818) were assigned to a lozenge dose on the basis of nicotine dependence, assessed by time to the first cigarette of the day. Low-dependence smokers were randomized to receive the 2-mg nicotine (n = 459) or placebo (n = 458) lozenge; high-dependence smokers, the 4-mg nicotine (n = 450) or placebo (n = 451) lozenge. We assessed abstinence at 6, 12, 24, and 52 weeks and analyzed craving and withdrawal symptoms. RESULTS: Treatment with the nicotine lozenge resulted in significantly greater 28-day abstinence at 6 weeks, for the 2-mg (46.0% vs. 29.7%; odds ratio [OR], 2.10; 95% confidence interval [CI], 1.59-2.79; P<.001) and the 4-mg (48.7% vs. 20.8%; OR, 3.69; 95% CI, 2.74-4.96; P<.001) lozenges, compared with placebo. Significant treatment effects were maintained for a full year. Smokers who used more lozenges achieved significantly better treatment effects. Use of the active lozenge also resulted in reduced craving and withdrawal. Most adverse events were moderate and resembled those seen with nicotine gum. CONCLUSION: The nicotine lozenge is a safe and effective new treatment for smoking cessation in low- and high-dependence smokers.

Adult↗
PubMed2002

Psychosocial demands and ambulatory blood pressure: a field assessment approach.

Ambulatory blood pressure (ABP) has been shown to have independent prognostic value, over and beyond the effects of clinic blood pressure (CBP) measures. We have examined the role of psychosocial demands in understanding ABP, using an electronic diary to measure ongoing experience in the field at the time of each blood pressure reading (ecological momentary assessment). In our previous work, several psychosocial factors were shown to be associated, within-person, with acute fluctuations in ABP in a healthy adult sample. Here, we replicate these findings in a new sample, and we also examine associations of the same variables with mean ABP (between-person) over a 6-day period. Five measures assumed to be markers of psychosocial demands (negative affect, arousal, task demand, decisional control, and social conflict) were shown here to be independently associated with ABP fluctuations during daily life, after adjustment for posture, activity, and substance use. Two of these, measures of task demand and decisional control, were also associated with mean ambulatory systolic blood pressure (SBP), and these latter associations persisted after controlling for CBP. These results support the possibility that psychosocial factors may account for some of the unique predictive value associated with ABP, and they support the value of these field assessment methods.

Aged↗
PubMed2002

Using qualitative research to inform survey development on nicotine dependence among adolescents.

Researchers interested in measuring tobacco use and dependence among youth face several formidable challenges. These challenges include: most existing measures have been developed for adult samples and may not be suitable for adolescent respondents; surveys must be relevant to different youth subcultures and to both genders; questions must be developmentally appropriate and not perceived as judgmental or condescending; and the multidimensional nature of nicotine dependence in youth must be recognized and measured. This paper demonstrates how researchers can address these challenges by using qualitative techniques to obtain information on youth tobacco consumption, and then using this information to inform the development of quantitative instruments. A case study is presented where a measure of tobacco dependence originally developed for adults is adapted for use with adolescents. A seven-step formative research process is outlined, consisting of gathering information in open-ended interviews, conducting follow-up research, modification of questionnaire items and addition of new items based on the information gathered, constructing a reliable instrument that is readable and acceptable to youth, reducing the length of this instrument without significantly hurting reliability and validity, conducting additional follow-up research involving case studies, and examining cultural differences. Following a formative research process like this one will help tobacco researchers gain a better understanding of how nicotine dependence develops.

Adolescent↗
PubMed2002

Immediate antecedents of cigarette smoking: an analysis from ecological momentary assessment.

The authors assessed the association between smoking and situational cues, including affect, in real-world contexts. Using ecological momentary assessment, 304 smokers monitored ad-lib smoking for 1 week, recording each cigarette on palm-top computers. Generalized estimating equations contrasted 10,084 smoking and 11,155 nonsmoking situations. After controlling for smoking restrictions, smoking was strongly related to smoking urges and modestly related to consumption of coffee and food, the presence of other smokers, and several activities. Smoking was unrelated to negative or positive affect or to arousal, although it was associated with restlessness. Thus, in daily life, affect appears to exert little influence over ad-lib smoking in heavy smoking adults.

Adult↗
PubMed2002

Using self-efficacy judgments to predict characteristics of lapses to smoking.

According to relapse prevention theory, abstinence self-efficacy judgments (ASE; confidence in ability to abstain from smoking) about particular affective and environmental contexts should predict behavior in those contexts. Low-ASE contexts should present challenges to abstinence. In this study, the authors used profile correlations to quantify the relationship between context-specific ASE ratings and the characteristics of lapse episodes. To assess the distinctiveness of this relationship, they also correlated the situations surrounding temptation and randomly selected (nontemptation) episodes with context-specific ASE. The ASE-first lapse profile correlation was significantly greater than zero and significantly greater than ASE-temptation and ASE-nontemptation correlations. This pattern of results remained when multiple lapse episodes were considered. Thus, low-ASE contexts tend to be associated with lapses to smoking.

Adult↗
PubMed2002

Real-world efficacy of prescription and over-the-counter nicotine replacement therapy.

AIMS: To assess smoking cessation rates achieved with nicotine gum and patch in simulated over-the-counter (OTC) and actual prescription (Rx) settings. DESIGN: Separate open-label studies with gum and patch in OTC and Rx settings. PARTICIPANTS: There were multiple samples: OTC gum: 2981 smokers; OTC patch: 2367; Rx gum: 324; Rx patch: 669. INTERVENTIONS: All smokers received active nicotine replacement. In the OTC setting, smokers self-selected doses of nicotine gum (2 or 4 mg Nicorette) or patch (21, 14 or 7 mg NicoDerm CQ). No intervention was provided. In the Rx setting, smokers were prescribed gum or patch by their physician. MEASUREMENTS: Biochemically verified continuous smoking abstinence was assessed at 6 weeks (28-day abstinence) and 6 months. FINDINGS: OTC success rates were consistently higher than Rx rates: differences were significant at 6 weeks for both patch [OR = 1.45 (1.05-1.98)] and gum [OR 2.92 (1.58-5.40)], and remained significant at 6 months for patch [OR = 3.63: (1.74-7.61)] but not gum [OR = 1.37: (0.73-2.58)]. Among OTC gum users. 16.1% were abstinent at 6 weeks and 8.4% at 6 months. For Rx gum users, abstinence rates were 7.7% at 6 weeks and 7.7% at 6 months. With OTC patch, 19.0% were abstinent at 6 weeks and 9.2% at 6 months. With Rx patch. abstinence rates were 16.0% at 6 weeks and 3.0% at 6 months. CONCLUSIONS: Smoking cessation rates achieved with nicotine gum and patch under OTC conditions were as good as those under real-world prescribing conditions.

Adult↗
PubMed2002

Efficacy of over-the-counter nicotine patch.

This study aimed to assess the efficacy of the nicotine patch for smoking cessation, under simulated conditions of over-the-counter sale, absent any direct instruction or behavioral treatment. In a randomized, double-blind, placebo-controlled, multicenter study, 567 smokers were randomized to an active nicotine patch (n = 283) or placebo (n = 284). Treatment followed a three-step program of 21 mg/day for 6 weeks, 14 mg/day for 2 weeks and 7 mg/day for 2 weeks. Participants received brief written instructions, an audiotape and a written User's Guide. There was no other intervention and no contact with participants between enrollment and the primary outcome assessment at 6 weeks. Analyses were based on intent to treat, with lost subjects counted as failures, and claimed abstinence was verified by carbon monoxide measures. Use of active patch produced significantly higher abstinence rates. Continuous abstinence rates (subject to a 2-week grace period) for nicotine and placebo were 19.4% and 7.0% at 6 weeks (OR = 3.2; 95% CI 1.8-5.4) and 15.2% and 5.3% at 10 weeks (OR = 3.2; 95% CI 1.7-5.9), respectively. Seven-day point-prevalence rates for nicotine and placebo patches were 26.1% and 7.7% at 6 weeks (OR = 4.2; 95% CI 2.5-7.0) and 23.3% and 7.7% at 10 weeks (OR = 3.6; 95% CI 2.2-6.1), respectively. Reported adverse events were mild and consistent with prior observations of nicotine patch use. The nicotine patch was safe and effective for smoking cessation at least during 10 weeks of treatment under open-sale conditions, without face-to-face instruction or counseling.

Administration, Topical↗
PubMed2002

Tobacco harm reduction: conceptual structure and nomenclature for analysis and research.

The goal of tobacco control has always been to reduce death and disease due to tobacco use. Recent discussions have broadened the concept of tobacco control beyond cessation and prevention to include concepts such as the use of medications to achieve reduction in tobacco use, chemoprevention to reduce disease, modifications of tobacco products to reduce toxicity, and behavioral approaches to change smoking and tobacco use behavior. Within each of these broad domains, diverse approaches have been suggested. To facilitate clear discussion and analysis, and to avoid confusion among approaches, we catalog 19 approaches to harm reduction, distinguishing and discussing them on 11 dimensions, including their objectives, mechanisms, toxicology, expected population risks, and consumer appeal. Because there have also been so many suggested applications of medicinal nicotine to smoking intervention, we separately catalog and analyze nine applications, some of which constitute new approaches to harm reduction. The suggested framework is intended to clarify the debate, provide for common nomenclature, and facilitate analysis of diverse approaches to tobacco harm reduction.

Harm Reduction↗
PubMed2002

Capturing momentary, self-report data: a proposal for reporting guidelines.

Self-report data are ubiquitous in behavioral and medical research. Retrospective assessment strategies are prone to recall bias and distortion. New techniques for assessing immediate experiences in respondents' natural environments (e.g., Ecological Momentary Assessment, Experience Sampling) are being used by many researchers to reduce reporting bias. This article discusses seven aspects of momentary research that are often overlooked or minimized in the presentation of momentary research reports, yet that are critical to the success of the research: (a) the rationale for the momentary sampling design, (b) the details of momentary sampling procedures, (c) the data acquisition interface, (d) rates of compliance with the sampling plan, (e) the procedures used to train and monitor participants, (f) data management procedures, and (g) the data analytic approach. Attention to these areas in both the design and reporting of momentary research studies will not only improve momentary research protocols but also allow for the successful replication of research findings by other investigators.

Guidelines as Topic↗
PubMed2002

Hostility explains some of the discrepancy between daytime ambulatory and clinic blood pressures.

The authors examined whether hostility explained the discrepancy commonly observed between clinic and daytime ambulatory blood pressures. Daytime ambulatory blood pressure (DABP) was assessed every 45 min over 6 days in healthy adults (N = 120). After controlling for demographic variables, time-varying covariates such as position and activity level, and clinic blood pressure (CBP), the Cook-Medley Hostility Scale was significantly associated with daytime ambulatory diastolic blood pressure. No support was obtained for mediation by psychological factors. Discrepancies between DABP and CBP may be due, in part, to differences in the degree to which these 2 types of measures are associated with individual differences in hostility. These results suggest that the addition of hostility to CBP may improve its predictive power.

Adult↗
PubMed2002

The effect of anticipatory strategies on the first day of smoking cessation.

The authors tested a model hypothesizing the predictors and the effects of anticipatory strategy use on the 1st day of smoking cessation using data from 63 participants in an ecological momentary assessment study of smoking cessation. Remaining abstinent on the 1st day of cessation was not associated with mean level of urges to smoke during tempting situations but was associated with anticipatory strategy use, which accounted for 18% of the variance. Getting rid of cigarettes contributed the most to this effect (beta = -.397). Getting rid of cigarettes was itself predicted by 2 variables, lower nicotine dependence (beta = -.264) and attending a formal smoking cessation class (beta = .305), which accounted for 15% of its variance.

Adult↗