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Biomedical subjects

Saul Shiffman

Publications and source records attributed to Saul Shiffman.

At least 55 records · Page 3Linked to original sources
PubMed2004

Playful and rebellious states vs. negative affect in explaining the occurrence of temptations and lapses during smoking cessation.

Reversal theory constructs of playful and rebellious states are compared with negative affect as predictors of temptations and lapses and as predictors of three important correlates of resisting temptations to smoke: Cigarette availability, urge level, and coping during temptations. A total of 61 participants entered data in palmtop computers and tape recorders for the first 14 days of a cessation attempt. Multilevel, random-effects logistic regression analyses showed that fluctuations in playfulness, rebelliousness, negative affect, and cigarette availability all significantly discriminated temptations from nontemptations. Fluctuations in playfulness and rebelliousness, but not negative affect, significantly predicted being in situations where cigarettes were easily available. Fluctuations in playfulness, rebelliousness, and cigarette availability, but not urge levels or negative affect, significantly predicted coping during temptations, whereas coping, rebelliousness, cigarette availability, and urge levels predicted lapsing. Treatment and policy implications of these findings are discussed.

Adult↗
PubMed2004

Recommendation for the assessment of tobacco craving and withdrawal in smoking cessation trials.

This paper addresses methodological issues in the assessment of nicotine withdrawal and craving in clinical trials of smoking cessation therapies. We define withdrawal as a syndrome of behavioral, affective, cognitive, and physiological symptoms, typically transient, emerging upon cessation or reduction of tobacco use and causing distress or impairment of behavioral function. Offset effects (effects related to removal of a direct nicotine effect) are sustained effects of cessation or reduction of tobacco use that cause distress or impairment. Withdrawal and craving are important as potential predictors of relapse, as mediators and markers of treatment effects, and as clinical phenomena in their own right. Symptoms recommended for assessment include craving, irritability, depression, restlessness, sleep disturbance, difficulty concentrating, increased appetite, and weight gain; anxiety deserves further study. We recommend reporting of data on each of these individual symptoms, and use of multiple-item assessments. Although some standardized measures of withdrawal have promising psychometric properties, no measure has yet fully established its reliability, validity, and broad applicability and, therefore, we do not currently favor universal adoption of any one measure. Assessment of objective indices of withdrawal (e.g., hormonal changes) is currently technically challenging and of unknown value. Although weekly assessment may suffice in some large trials, more intensive measurement can provide better sensitivity. Analyses of withdrawal should include baseline measures and be sensitive to potential instability in baseline. Analytic approaches should take into account potential bias when only abstinent subjects are examined. Conversely, heterogeneity should be considered when smoking subjects are included in intent-to-treat analyses. Withdrawal data from clinical trials focused on assessing abstinence rates may be biased because of progressive subject loss to dropout and relapse; different designs and approaches are needed to investigate the process and natural history of craving and withdrawal.

Clinical Trials as Topic↗
PubMed2004

The nicotine dependence syndrome scale: a multidimensional measure of nicotine dependence.

We report the development of a new multidimensional questionnaire to measure nicotine dependence, based on Edwards's syndromal conceptualization of dependence. We present three studies. In study 1, we administered the Nicotine Dependence Syndrome Scale (NDSS) to 317 smokers in a smoking cessation study. Factor analysis of the NDSS revealed five factors: Drive (craving and withdrawal, and subjective compulsion to smoke), priority (preference for smoking over other reinforcers), tolerance (reduced sensitivity to the effects of smoking), continuity (regularity of smoking rate), and stereotypy (invariance of smoking). A single overall score based on the first principal component, NDSS-T, was retained as a single core measure of dependence. The NDSS showed promising psychometric properties: NDSS-T and factor scores showed strong associations with dependence-relevant measures, even when we controlled for scores on the Fagerström Tolerance Questionnaire (FTQ); and the NDSS predicted urges when smoking, withdrawal in acute abstinence, and outcome in cessation. The five factor scores showed differential patterns of correlations with external validators, supporting the multidimensionality of the measure. In study 2, we revised the NDSS to expand some subscales and administered it to 802 smokers in a cessation study. The same five factors were extracted, the internal reliability of some subscales was improved, and the factor scores again showed associations with dependence-relevant validators, which were largely maintained when we controlled for FTQ scores. In study 3, with 91 smokers in a cessation trial, we established that the test-retest reliability of the subscales was adequate. Thus, the NDSS presents a valid multidimensional assessment of nicotine dependence that may expand on current measures.

Adult↗
PubMed2004

Successful treatment with a nicotine lozenge of smokers with prior failure in pharmacological therapy.

AIMS: To assess the influence of unsuccessful past quit attempts using pharmacological treatment on smoking cessation when using a new nicotine lozenge. DESIGN: A double-blind, randomized, placebo-controlled trial. SETTING: Fifteen sites in the United Kingdom and the United States. PARTICIPANTS: A total of 1818 smokers seeking smoking cessation treatment; 1145 had had previous pharmacological treatment for smoking cessation. INTERVENTION: Lozenge, 2 mg or 4 mg (or matched placebo); a higher dose was assigned to smokers who smoked their first cigarette of the day within 30 minutes, a sign of dependence. Smokers received minimal instruction and counseling. MEASUREMENT: Outcome was 28-day, CO-verified continuous abstinence at 6 weeks. Past use of medications was ascertained by self-report. FINDINGS: Lozenge was efficacious among smokers with prior pharmacotherapy as well as among those without such history. The effect of lozenge (versus placebo) was significantly greater among those with previous treatment experience, because previous treatment was associated with significantly poorer outcome on placebo, and active lozenge treatment corrected this imbalance. Lozenge efficacy was similar whether smokers had previously tried patch or acute forms of nicotine replacement therapy (gum, inhaler and spray), and also similar for past use of Zyban (bupriopion). CONCLUSIONS: Smokers with a history of past failure of pharmacological treatment have lower success rates without pharmacological treatment, but equally good outcomes with active lozenge treatment. Smokers who previously tried pharmacological treatments but resumed smoking should be encouraged to try quitting again with the new nicotine lozenge.

Double-Blind Method↗
PubMed2004

What can dependence theories tell us about assessing the emergence of tobacco dependence?

Little is known about the processes that underlie changes in smoking that occur between the first use of a cigarette, subsequent regular use and eventual addictive use. At present, assessments of those critical processes are poorly developed and not strongly informed by contemporary models of drug dependence. The preceding three papers in this special issue address explicitly how modern drug-dependence theories describe the emergence of drug dependence and the implications of those theories for assessment. The papers covered three domains of theories: negative reinforcement, positive reinforcement, and cognitive and social learning. In this paper, we summarize these reviews and extract general themes and issues that emerge across all the articles. These include: (1) the importance of learning processes; (2) limitations of self-report measures; (3) the view of dependence as a process and not a state; (4) the conception of dependence on a continuum in contrast to the conventional perspective of tobacco dependence as a natural category; (5) the ontological status of the dependence concept; (6) limitations of backward extrapolations from adult assessments; (7) the possibility of multiple dimensions or forms of dependence; and (8) the value of a transdisciplinary approach when studying the emergence of tobacco dependence.

Behavior, Addictive↗
PubMed2004

Are there gender differences in smoking cessation, with and without bupropion? Pooled- and meta-analyses of clinical trials of Bupropion SR.

AIMS: In this study, we examine gender differences in smoking cessation with and without treatment with Bupropion SR. We test whether women and men have comparable success rates quitting smoking regardless of treatment, whether Bupropion SR is effective for women, and whether Bupropion SR efficacy differs for men and women. DESIGN: A literature search was conducted to identify relevant trials. Data were analyzed with individual-level (pooled) and study-level (meta-analytical) statistics. PARTICIPANTS: Data from 4421 participants in 12 randomized smoking cessation trials of Bupropion SR 300 mg versus placebo were analyzed. FINDINGS: Results from the meta-analysis revealed that Bupropion SR was an effective aid to smoking cessation [odds ratio (OR) = 2.49, 95% confidence interval (CI) = 2.06-3.00]. Moreover, Bupropion SR proved to be an effective cessation aid for women (OR = 2.47, 95% CI = 1.92-3.17). No treatment-gender interaction was observed; women and men benefited equally from treatment with Bupropion SR (Q = 0.01, NS). Overall, women were less successful at quitting than men, regardless of treatment (OR = 0.79, 95% CI = 0.65-0.95). These results were replicated with pooled, individual-level analyses. CONCLUSIONS: Bupropion SR is an effective smoking cessation aid for women. In these trials, women have less success quitting smoking than men, whether treated with Bupropion SR or placebo. There is a need to understand more about why women are less able to quit.

Adult↗
PubMed2004

Validation of the Detroit Area Study Discrimination Scale in a community sample of older African American adults: the Pittsburgh healthy heart project.

This study examined the construct validity of the Detroit Area Study Discrimination Questionnaire (DAS-DQ) in 49 healthy African American adults, with respect to its association with global measures and daily experiences of psychological demand. Daily experiences of psychological demand were obtained using ecological momentary assessment (EMA) methods. Everyday Mistreatment, as measured by the DAS-DQ, was significantly related to global reports of perceived stress and depression but was unrelated to measures of hostility and social desirability. Everyday Mistreatment was significantly related to average EMA score measures of Negative Affect and Social Conflict but was unrelated to daily experiences of Task Demand or Decisional Control. Negative Affect mediated the relation between Everyday Mistreatment and global reports of perceived stress. In contrast, Lifetime History of Discrimination, as measured by the DAS-DQ, was unrelated to global measures or daily experiences of stress. Thus, this study lends support to the construct validity of the DAS-DQ.

Aged↗
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

Correspondence between laboratory and ambulatory measures of cardiovascular reactivity: a multilevel modeling approach.

We examined the correspondence between laboratory measures of cardiovascular reactivity (CVR) and within-person changes in cardiovascular activity during the challenges of daily life, after adjustment for posture, activity, and other effects. Healthy adults (n = 335) were administered laboratory measures of CVR along with 6 days of ambulatory blood pressure monitoring and electronic diary reports. Compared with low reactors, high laboratory systolic blood pressure (SBP) reactors showed larger increases in SBP during periods of high task demand or low decisional control in daily life. High diastolic blood pressure (DBP) reactors showed larger increases in ambulatory DBP during situations rated as both low control and high demand. This multilevel modeling approach may enhance our ability to detect the correspondence between laboratory and ambulatory measures of CVR, and to identify the circumstances under which it may be most clearly observed.

Aged↗
PubMed2003

Patterns of over-the-counter nicotine gum use: persistent use and concurrent smoking.

AIMS: To examine the occurrence of persistent use (i.e. use beyond 12 weeks) and concurrent use of nicotine gum with cigarettes among consumers who purchase nicotine gum over-the-counter (OTC). DESIGN: Assessment of gum use was conducted in the context of a smoking cessation trial among smokers who purchased Nicorette gum and enrolled in the optional Committed Quitters smoking cessation program. Eligible participants were contacted by telephone 6 weeks and 12 weeks following their self-selected target quit date. Those who reported gum use at 12 weeks were contacted again at week 24. PARTICIPANTS: A total of 2655 current smokers who purchased nicotine gum and enrolled in a clinical efficacy trial of the Committed Quitters program. MEASUREMENTS: Detailed information on smoking and gum use, including frequency of use, amount used and reasons for use was obtained at each of the three follow-up assessments. FINDINGS: At the 24-week assessment, 6% of participants reported current use of nicotine gum (i.e. persistent use). Those engaging in persistent use averaged 4.7 (SD = 2.5) days of gum use per week and 3.2 (SD = 3.5) pieces of gum per day. Sixty-six per cent of persistent users reported at week 24 that they were not currently smoking, and 67% of persistent users reported they were using gum to establish or maintain abstinence. At the 6-, 12- and 24-week assessments, 14%, 10% and 2% of participants, respectively, reported current use of nicotine gum and current cigarette smoking (i.e. concurrent users). Those concurrent users reported at the 12-week follow-up that they did so an average of 4.4 (SD = 2.1) days per week, that they chewed an average of 2.6 (SD = 3.5) pieces of nicotine gum per day and that they smoked an average of 8.7 (SD = 8.6) cigarettes per day. CONCLUSION: Extended use of nicotine gum is rare. Concurrent use with cigarettes is uncommon. In both cases, the amount of gum use is small. OTC marketing of nicotine gum does not appear to have increased use contrary to labeling nor resulted in patterns of use that should warrant clinical or public health concerns.

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↗