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Polymorphisms of the mu-opioid receptor (OPRM1) and dopamine D4 receptor (DRD4) genes are associated with subjective responses to alcohol and urge to drink under laboratory conditions. This study examined these associations in the natural environment using ecological momentary assessment. Participants were non-treatment-seeking heavy drinkers (n = 112, 52% female, 61% alcohol dependent) who enrolled in a study of naltrexone effects on craving and drinking in the natural environment. Data were culled from 5 consecutive days of drinking reports prior to medication randomization. Analyses revealed that, after drinking, carriers of the Asp40 allele of the OPRM1 gene reported higher overall levels of vigor and lower levels negative mood, as compared to homozygotes for the Asn40 variant. Carriers of the long allele (i.e., >or=7 tandem repeats) of the DRD4 endorsed greater urge to drink than homozygotes for the short allele. Effects of OPRM1 and DRD4 variable-number-of-tandem-repeats genotypes appear to be alcohol dose-dependent. Specifically, carriers of the DRD4-L allele reported slight decreases in urge to drink at higher levels of estimated blood alcohol concentration (eBAC), and Asp40 carriers reported decreases in vigor and increases in negative mood as eBAC rose, as compared to carriers of the major allele for each gene. Self-reported vigor and urge to drink were positively associated with alcohol consumption within the same drinking episode. This study extends findings on subjective intoxication, urge to drink, and their genetic bases from controlled laboratory to naturalistic settings. [ABSTRACT FROM AUTHOR]

The incentive-sensitization theory (IST) has emerged as a potentially useful theory in explaining substance addiction. IST postulates that the prolonged use of a substance can alter neural systems that are often involved in incentive motivation and reward processes, leading to an increased "sensitization" to the substance and associated stimuli. However, this increased sensitization is thought to mediate only the individual's craving of the substance (e.g., their "wanting"), not their enjoyment of the substance (e.g., their "liking"), a process that may involve unconscious implicit changes in cognitive networks linked to specific substances. Consequently, IST may better explain the real-world dissonance reported for individuals who want to accomplish long-term substance cessation but fail to do so, a phenomenon that is common in adolescent smokers. Thus, the present study aimed to examine the principles of IST in a sample of 154 adolescent ad libitum smokers ( M age = 16.57, SD age = 1.12, 61.14% male) utilizing ecological momentary assessment. Data were analyzed utilizing a multilevel structural equation model examining changes in positive affect (PA), negative affect (NA), and stress from Time 1 (T1) and Time 2 (T2) as a function of smoking and tested the influence of implicit cognition (specifically, implicit attitudes about smoking [Implicit Association Test (IAT)]) on these associations. Consistent with the principles of IST, results found a modest significant negative association between smoking status at T1 and PA at T2 ( B = -0.11, p = .047). This association was further moderated by IAT ( B = -0.19, p = .029) and was particularly potentiated at high levels of IAT (B = -0.44, p < .001), compared to low ( B = -0.05, p = .663) or mean levels of IAT ( B = -0.25, p = .004). Findings from this study provide additional support to the principles underlying IST and indicate that, in adolescents, smoking may result in thwarted PA indicative of a transition from "liking" toward "wanting," and this is especially pronounced among those with stronger implicit smoking cognitions. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Introduction: Most adolescent smokers report a desire to quit, and many have made several unsuccessful quit attempts; however, when adolescents attempt to quit, they often resume smoking quickly. This ecological study aimed to (1) characterize affective and situational precipitants of smoking lapses among adolescents and (2) explore the moderating influence of nicotine dependence severity on lapse precipitants., Methods: Adolescent daily smokers (n = 166; ages 14-18 years) completed electronic diaries of cigarettes smoked, craving and affective states, and situational variables on handheld computers in their natural environment for 2 weeks following an unassisted quit attempt. On average, adolescents were moderately nicotine dependent (Modified Fagerström Tolerance Questionnaire [mFTQ] score = 4.9; SD = 1.6)., Results: Craving was a significant episodic cue for lapse and stable influence on lapse, relating to 44% and 15% increased odds of lapse, respectively. High-arousal affective states-regardless of valence-were associated with 12%-13% increased odds of lapse. Low-arousal positive affective states were associated with 17% decreased odds of lapse. A 1-unit difference in a teen's mFTQ score related to 27% increased odds of lapse, but dependence severity did not moderate proximal lapse influences., Conclusions: This report provides some of the first ecological data characterizing adolescent smoking lapses following a quit attempt. As in prior work with teens, lapses were nearly universal and quickly followed the quit attempt. Specific situational and affective contexts of smoking lapses for adolescents were implicated, indicating the need for cessation interventions to address craving and high-arousal affective states as precipitators of lapse in this high-risk group., Implications: This report provides some of the first ecological data characterizing smoking lapses among teens attempting to quit smoking on their own. Like adults, adolescents face many barriers when making quit attempts. The present work provides ecological data to suggest that the experience of heightened arousal in teens' daily lives interferes with their efforts to quit smoking. Thus, this work highlights the importance of affective dysregulation, or amplitude of emotional feelings, for teen smoking lapses. Moment-to-moment fluctuation in craving was also implicated as a dynamic precipitator of smoking lapse in this high-risk group., (© The Author(s) 2019. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.For permissions, please e-mail: journals.permissions@oup.com.)

Background: This paper outlines the creation of an intuitive, personalized evaluation framework for Patient-Reported Outcomes, using the EQ-5D visual analog scale (VAS) as an illustration., Methods: A draft framework asked patients to divide and label the EQ-5D-VAS into different levels or categories of health. Comprehension of the framework and patient-defined health level labels, and how they map onto the EQ-5D-VAS, were tested through in-person, semi-structured interviews with individuals self-reporting cardiovascular disease. Interviews were conducted in three waves, with the framework revised between waves., Results: Analyses included 14 participants. Eight participants (57.1%) felt that four levels of health were appropriate and there was general agreement on the labels; Poor, Fair, Good, and Excellent. There was substantial variability in where patients drew lines to indicate the level boundaries; Poor ranged between 0 and 50; Fair 10-75; Good 40-91; Excellent 60-100. In wave 3, all participants demonstrated appropriate comprehension of the framework., Conclusions: The framework was well understood. The wide range of margins and the extent of overlap between the levels provide strong evidence for the relevance of the personalized evaluation framework approach, and specifically a personalized EQ-5D-VAS evaluation framework, to better understand and interpret each individual's response to the item.

Reducing smoking among adolescents is a public health priority. Affect, craving, and cognitive processes have been identified as predictors of smoking in adolescents. The current study examined associations between implicit attitude for smoking (assessed via the positive-negative valence implicit association test) and affect, craving, and smoking assessed using ecological momentary assessment (EMA). Adolescent smokers (n = 154; Mage = 16.57, SD = 1.12) completed a laboratory assessment of implicit smoking attitudes and carried a palm-top computer for several days while smoking ad libitum. During EMA, they recorded affect, craving, and smoking behavior. Data were analyzed using a multilevel path analysis. At the between-subjects level, more positive implicit smoking attitude was indirectly associated with smoking rate via craving. This association was moderated by positive affect, such that it was stronger for those with greater traitlike positive affect. At the event (within-subject) level, implicit attitude potentiated associations between stress and craving and between positive affect and craving. Individuals with a more positive implicit attitude exhibited more robust indirect associations between momentary stress-positive affect and smoking. In sum, a more positive implicit attitude to smoking was associated with overall levels of craving and smoking and might have potentiated momentary affect-craving associations. Interventions that modify implicit attitude may be an approach for reducing adolescent smoking. (PsycINFO Database Record, ((c) 2018 APA, all rights reserved).)

Cannabis misuse accounts for nearly all of the substance abuse treatment admissions among youth in the United States. Most youth do not experience sustained benefit from existing psychosocial treatments; however, medication development research for treating adolescent cannabis misuse is almost nonexistent. We conducted a double-blind, placebo-controlled, pilot study to test the potential efficacy of topiramate plus motivational enhancement therapy (MET) for treating cannabis use among adolescents. Sixty-six heavy cannabis users, ages 15 to 24 years, were randomized to one of two 6-week treatment conditions: topiramate plus MET or placebo plus MET. Topiramate was titrated over 4 weeks then stabilized at 200 mg/day for 2 weeks. MET was delivered biweekly for a total of three sessions. Only 48 percent of youths randomized to topiramate completed the 6-week trial (n = 19), compared with 77 percent of youths in the placebo condition (n = 20). Adverse medication side effects were the most common reason for withdrawal among participants in the topiramate group. Latent growth models showed that topiramate was superior to placebo for reducing the number of grams smoked per use day, but it did not improve abstinence rates. The same pattern of results was found when values for missing outcomes were imputed. We show that topiramate combined with MET demonstrated efficacy for reducing how much cannabis adolescents smoked when they used but did not affect abstinence rates. The magnitude of this effect was modest, however, and topiramate was poorly tolerated by youths, which calls into question the clinical importance of these findings., (© 2016 Society for the Study of Addiction.)

Affective response to exercise may mediate the effects of self-paced exercise on exercise adherence. Fiftynine low-active (exercise <60 min/week), overweight (body mass index: 25.0-39.9) adults (ages 18-65) were randomly assigned to self-paced (but not to exceed 76% maximum heart rate) or prescribed moderate intensity exercise (64-76% maximum heart rate) in the context of otherwise identical 6-month print-based exercise promotion programs. Frequency and duration of exercise sessions and affective responses (good/bad) to exercise were assessed via ecological momentary assessment throughout the 6-month program. A regression-based mediation model was used to estimate (a) effects of experimental condition on affective response to exercise (path a = 0.20, SE = 0.28, f 2 = 0.02); (b) effects of affective response on duration/latency of the next exercise session (path b = 0.47, SE = 0.25, f 2 = 0.04); and (c) indirect effects of experimental condition on exercise outcomes via affective response (path ab = 0.11, SE = 0.06, f 2 = 0.10). Results provide modest preliminary support for a mediational pathway linking self-paced exercise, affective response, and exercise adherence.

Objective: Although a great deal of adolescent smoking research has investigated predictors of initiation, much less has focused on predictors of lapsing during a quit attempt. In particular, the role of social context may deserve greater attention in models of adolescent smoking cessation. Therefore, the present investigation aimed to use ecological momentary assessment (EMA) to examine individual differences in social lapsing--the extent to which lapses occur around others versus when alone., Methods: Analyses focused on 179 adolescent smokers (aged 14-18 years) engaged in an unassisted quit attempt. There were 2 general EMA assessment intervals: prequit (1 week) and postquit (2 weeks). Participants reported every time that they smoked a cigarette and at random, nonsmoking times; in each assessment, participants responded to questions about their current environment, behaviors, and psychological state. A 3-month follow-up assessed longer-term smoking-related outcomes., Results: Consistent with other adolescent research, the overall rate of lapsing was very high (93%). Social lapsing rates were likewise high (among those who lapsed, 73% reported their first lapse was social), but they also varied continuously across individuals. We computed a social lapsing coefficient for each youth and found that it related to smoking factors at baseline (e.g., lower smoking intensity and dependence) and follow-up (e.g., lower cotinine levels)., Conclusions: These results suggest that higher rates of social lapsing are associated with being a lighter, less dependent smoker and having better eventual cessation prospects. Findings provide evidence that accounting for variability in social lapsing may improve theory and treatment., ((c) 2015 APA, all rights reserved).)

Background: National guidelines call for exercise of at least moderate intensity; however, recommending self-paced exercise may lead to better adherence, particularly among overweight and obese adults., Purpose: The purpose of this study was to test proof-of-concept for recommending self-paced exercise among overweight adults., Methods: Fifty-nine healthy, low-active (exercise <60 min/week), overweight (body mass index 25.0-39.9) adults (18-65) received a 6-month print-based exercise promotion program with the goal of walking 30-60 min/day. Participants were surreptitiously randomly assigned to receive a recommendation for either self-paced (n = 30) or moderate (64-76 % maximum heart rate; n = 29) intensity exercise. All participants used electronic diaries and heart rate monitors to track exercise frequency, duration, and intensity., Results: The self-paced condition reported more minutes/week of walking (f (2) = 0.17, p = 0.045) and a trend toward greater exercise-related energy expenditure/week (f (2) = 0.12, p = 0.243), corresponding to approximately 26 additional minutes/week and 83 additional kilocalories/week over 6 months., Conclusions: Explicit recommendation for self-paced exercise may improve adherence to exercise programs among overweight and obese adults.

Objective: Effects of brief motivational interventions (BMIs) for heavy drinkers identified by alcohol-related emergency department (ED) visits are mixed. The successes of including significant others (SOs) in behavioral treatment suggest that involving SOs in ED-delivered BMI might prove beneficial. This study investigated the relative efficacy of an SO-enhanced motivational intervention (SOMI) compared with an individual motivational intervention (IMI) to address heavy drinking in emergency care settings., Method: ED (n = 317) or trauma unit (n = 89) patients were randomly assigned to receive either an IMI or an SOMI and were reassessed at 6 and 12 months for alcohol consumption, alcohol-related consequences, and perceived alcohol-specific SO support., Results: Generalized estimating equation analyses showed consistent reductions over time for both alcohol consumption and consequences. At 1-year follow-up, the average reduction in total drinks consumed per week was greater for patients in the SOMI condition than the IMI condition. In SOMI, 9.4% more patients moved to within the national guidelines for weekly drinking than did IMI patients. Frequency of heavy drinking and negative alcohol consequences showed no differential effects of intervention., Conclusions: Emergence of a modest treatment effect at 12 months suggests that SO involvement in the SOMI condition may have led to more sustained positive influence on patient drinking than in the IMI condition. Implications and limitations regarding SO involvement in brief treatment are discussed.

Objective: Relapse to smoking after making a quit attempt is both common and rapid in adolescent smokers. Momentary self-efficacy (SE)-that is, momentary shifts in one's confidence in the ability to abstain from smoking-predicts the occurrence and timing of relapse among adolescent smokers. Therefore, it is important to identify factors that are associated with changes in momentary SE early in a quit attempt. This study examined the relationship between affect states (including positive, negative, and nicotine withdrawal states) and momentary SE at various stages of a quit attempt., Method: Adolescent daily smokers interested in making a quit attempt (n = 202) completed ecological momentary assessments (EMA) each day for 1 week leading up to and 2 weeks after a quit attempt. In each assessment, they reported current SE and affect state., Results: RESULTS of linear mixed models indicated that most of the examined affect states were related to momentary SE. Contrary to expectation, they were related to momentary SE both immediately before and after the quit attempt. Moderation effects were observed for select affect states, where higher baseline SE was related to lower momentary SE in the presence of increasing negative high activation, boredom, and difficulty concentrating., Conclusions: Our findings suggest that both positive and negative affect states are related to SE, and that thereby positive affect enhancement may be a promising, underutilized treatment target.

Objective: Examine the ability of baseline electronic Columbia-Suicide Severity Rating Scale lifetime suicidal ideation and behavior categories to predict prospective reports of suicidal behavior in psychiatric and non-psychiatric research participants., Design: Meta-analysis of 74,406 eC-SSRS assessments completed between September 2009 and December 2012., Setting: Thirty-three clinical research studies that used the electronic Columbia-Suicide Severity Rating Scale to assess suicidal ideation and behavior at baseline and prospectively during follow-up visits., Participants: Records from 6,760 patients with psychiatric disorders (opioid dependence, generalized anxiety, major depressive, and posttraumatic stress disorders) and 2,077 nonpsychiatric disorder patients (chronic obstructive pulmonary disease, epilepsy, fibromyalgia, human immunodeficiency virus, insomnia, multiple sclerosis, osteoarthritis, pain/back pain, Parkinson's disease, restless leg syndrome) were analyzed., Measurements: Electronic Columbia-Suicide Severity Rating Scale assessment of lifetime suicidal ideation (5 severity levels) and suicidal behavior (4 types) at baseline and prospectively reported suicidal behavior during study participation., Results: Increasingly more severe lifetime suicidal ideation at baseline was associated with a progressively greater likelihood of prospectively reported suicidal behavior during study participation. Intent to act on suicidal ideation was most predictive of reports of suicidal behavior. Reports of lifetime suicidal behaviors at baseline also predicted subsequent suicidal behavior, and multiple lifetime behaviors monotonically increased prospective risk of suicidal behavior. Baseline suicidal ideation and behavior predicted future suicidal behavior in both psychiatric and non-psychiatric trials., Conclusions: Lifetime reports of suicidal ideation and/or behavior at baseline significantly increased risk of prospectively reporting suicidal behavior during research trial participation in both psychiatric and nonpsychiatric patients. Lifetime prevalence of suicidal ideation and behavior is higher among psychiatric patients, but also presents a safety concern among nonpsychiatric patients when reported.

Adolescent alcohol use is associated with myriad adverse consequences and contributes to the leading causes of mortality among youth. Despite the magnitude of this public health problem, evidenced-based treatment initiatives for alcohol use disorders in youth remain inadequate. Identifying promising pharmacological approaches may improve treatment options. Naltrexone is an opiate receptor antagonist that is efficacious for reducing drinking in adults by attenuating craving and the rewarding effects of alcohol. Implications of these findings for adolescents are unclear; however, given that randomized trials of naltrexone with youth are non-existent. We conducted a randomized, double-blinded, placebo-controlled cross-over study, comparing naltrexone (50 mg/daily) and placebo in 22 adolescent problem drinkers aged 15-19 years (M = 18.36, standard deviation = 0.95; 12 women). The primary outcome measures were alcohol use, subjective responses to alcohol consumption, and alcohol-cue-elicited craving assessed in the natural environment using ecological momentary assessment methods, and craving and physiological reactivity assessed using standard alcohol cue reactivity procedures. Results showed that naltrexone reduced the likelihood of drinking and heavy drinking (P's ≤ 0.03), blunted craving in the laboratory and in the natural environment (P's ≤ 0.04), and altered subjective responses to alcohol consumption (P's ≤ 0.01). Naltrexone was generally well tolerated by participants. This study provides the first experimentally controlled evidence that naltrexone reduces drinking and craving, and alters subjective responses to alcohol in a sample of adolescent problem drinkers, and suggests larger clinical trials with long-term follow-ups are warranted., (© 2013 The Authors, Addiction Biology © 2013 Society for the Study of Addiction.)

Background: Chronic plaque psoriasis has a profound impact on a patient's daily life. To understand the effects of psoriasis treatments, it is essential to assess the patient's experience of symptoms and how they impact their daily life. The goal of this study was to develop and establish the content validity of a new patient reported outcome (PRO) psoriasis measure., Methods: The Psoriasis Symptom Diary was developed by (i) identifying key plaque psoriasis-related symptoms and impacts through qualitative patient interviews (n = 29); (ii) developing an initial set of items that captured the key patient experiences; and (iii) conducting cognitive interviews to test patient understanding of items selected for inclusion in the new psoriasis symptom measure (n = 16)., Results: Patients noted a variety of symptoms, with plaque-related pain (including related concepts of burning and stinging), changes in skin appearance, and itching reported by all patients. Patients also expressed notable embarrassment and avoidance of social situations, due to the appearance of plaques, and limited mobility. The Psoriasis Symptom Diary assesses the severity and impact of symptoms using a 24-hour recall period to reduce recall bias and error., Conclusions: The Psoriasis Symptom Diary was developed to assess important symptoms and disease-related impacts in a manner consistent with guidelines for establishing the content validity of new PRO instruments. Following quantitative psychometric testing, the Psoriasis Symptom Diary may support efficacy endpoints in clinical trials., (© 2013 The International Society of Dermatology.)

Theoretical models of alcoholism emphasize the acute reinforcing properties of alcohol as chief determinants of drinking, and animal research suggests adolescents are uniquely sensitive to these effects. Human studies of these phenomena, however, are virtually nonexistent. We used ecological momentary assessment methods to capture adolescents' subjective responses to alcohol in real time in their natural environments. Adolescent participants were 22 problem drinkers, ages 15 to 19 years (M = 18.3, SD = 0.09; 55% female; 55% alcohol dependent). Participants consumed alcohol on 38% of days during a 1-week monitoring period, with an average of 5 drinks per occasion. Momentary data revealed that adolescents experience decreased stimulation and increased sedation and "high" across the ascending limb of the blood alcohol curve. Notably, greater craving predicted higher volumes of subsequent alcohol consumption during the episode, whereas greater "high" attenuated use. To test for developmental differences in these effects, we pooled these data with data from a similarly ascertained sample of 36 adult heavy drinkers, ages 24 to 64 years (M = 38.1, SD = 11.8; 50% female; 61% alcohol dependent). Adolescents were more sensitive to the stimulant effects of alcohol than adults. This study provides novel data on how adolescent problem drinkers experience alcohol in their natural contexts and illustrates how these effects, which appear to differ from adult problem drinkers, confer liability for future drinking., (PsycINFO Database Record (c) 2014 APA, all rights reserved.)

Aerobic exercise has been proposed as a stand-alone or adjunct smoking cessation treatment, but findings have been mixed. Laboratory studies have shown that individual exercise sessions lead to decreases in withdrawal symptoms and cigarette cravings, but findings are limited by lack of follow-up and artificial settings. On the other hand, smoking cessation treatment RCTs have generally failed to show positive effects of exercise on smoking cessation, but have been plagued by poor and/or unverified compliance with exercise programs. This paper describes the rationale and design for Quit for Health (QFH)--an RCT designed to determine the efficacy of aerobic exercise as an adjunct smoking cessation treatment among women. To overcome limitations of previous research, compliance with the exercise (and wellness contact control) program is incentivized and directly observed, and ecological momentary assessment is used to examine change over time in withdrawal symptoms and cigarette cravings in participants' natural environments., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objectives: This research evaluated the psychometric properties of a new Psoriasis Symptom Diary, identified diary responder definitions for use in determining whether a patient has experienced clinically meaningful change, and refined diary item content for use in future clinical trials., Methods: The Psoriasis Symptom Diary was administered in a phase 2 clinical trial of AIN457 to US adult outpatients (N = 172) with physician-diagnosed moderate to severe chronic plaque-type psoriasis. Participant compliance with daily diary administration and item score variability, reliability, construct and discriminant validity, sensitivity to change, and interpretation were all evaluated., Results: Participants completed 94% of scheduled diary assessments across 12 study weeks. Diary items were generally normally distributed, and no floor or ceiling effects were observed. Item reliability (reproducibility) was acceptable (intraclass correlation coefficients > 0.80), with an exception for one item (skin color). At week 12, items significantly related to criterion measures as predicted (Psoriasis Area and Severity Index r = 0.27-0.57; Investigator's Global Assessment r = 0.25-0.59), with the exception of items that measured skin color and difficulty using hands. Most items generated change scores that were synchronous to changes as measured by the Psoriasis Area and Severity Index, Investigator's Global Assessment, Dermatology Life Quality Index (r > 0.37), as well as the Patient Global Impression of Change. Responders experienced a 2- to 3-point and 3- to 5-point change in item scores for minimal and large improvements, respectively. Four items that did not perform well were dropped from the diary., Conclusions: The 16-item Psoriasis Symptom Diary demonstrated favorable psychometric properties and is a brief, useful tool for measuring patient-based symptoms and the impact of chronic plaque psoriasis., (Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.)

High levels of trait hostility are associated with wide-ranging interpersonal deficits and heightened physiological response to social stressors. These deficits may be attributable in part to individual differences in the perception of social cues. The present study evaluated the ability to recognize facial emotion among 48 high hostile (HH) and 48 low hostile (LH) smokers and whether experimentally-manipulated acute nicotine deprivation moderated relations between hostility and facial emotion recognition. A computer program presented series of pictures of faces that morphed from a neutral emotion into increasing intensities of happiness, sadness, fear, or anger, and participants were asked to identify the emotion displayed as quickly as possible. Results indicated that HH smokers, relative to LH smokers, required a significantly greater intensity of emotion expression to recognize happiness. No differences were found for other emotions across HH and LH individuals, nor did nicotine deprivation moderate relations between hostility and emotion recognition. This is the first study to show that HH individuals are slower to recognize happy facial expressions and that this occurs regardless of recent tobacco abstinence. Difficulty recognizing happiness in others may impact the degree to which HH individuals are able to identify social approach signals and to receive social reinforcement.

The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts developers or users purport it to assess. A PRO instrument measures the concepts most relevant and important to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Part 1 of this task force report covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Building on qualitative interviews and focus groups used to elicit concepts, cognitive interviews help developers craft items that can be understood by respondents in the target population and can ultimately confirm that the final instrument is appropriate, comprehensive, and understandable in the target population. Part 2 details: 1) the methods for conducting cognitive interviews that address patient understanding of items, instructions, and response options; and 2) the methods for tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. The task force report's two parts are meant to be read together. They are intended to offer suggestions for good practice in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation., (Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts that developers or users purport it to assess. A PRO instrument measures the concepts most significant and relevant to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Developing content for, and assessing respondent understanding of, newly developed PRO instruments for medical product evaluation will be discussed in this two-part ISPOR PRO Good Research Practices Task Force Report. Topics include the methods for generating items, documenting item development, coding of qualitative data from item generation, cognitive interviewing, and tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. Part 1 covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Part 2 covers the instrument development process, the assessment of patient understanding of the draft instrument using cognitive interviews and steps for instrument revision. The two parts are meant to be read together. They are intended to offer suggestions for good practices in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation., (Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Despite increased attention to adolescent smoking cessation, little is known about adolescent relapse following a quit attempt. To address this issue, the present study was designed to provide initial information regarding the characteristics of adolescent lapses to smoking following abstinence. Included in the present study were 204 adolescent participants in four independent smoking cessation trials. For the full sample, participants averaged 15.99 (1.27) years of age; 56% were female and 78% were white. Lapse characteristics and precipitants were assessed using the Adolescent Smoking Relapse Review. Three domains of the lapse experience were assessed: lapse situation characteristics, precipitants of use in the situation, and proximal influences (i.e., potential precipitants occurring on the same day, prior to the lapse situation). Participant reports indicated that the modal lapse situation occurred in the evening while socializing with friends at home. Urges or cravings and social pressure were commonly endorsed as occurring in lapse situations. The most frequently reported proximal influence was desire for a cigarette, followed by abstinence-violation cognitions (okay to smoke occasionally, wanted to see what it would be like) and negative emotions. The findings indicate that a broad range of factors appear to influence adolescent smoking lapse and commend the value of incorporating content relevant to managing social and affective cues, strategies for inhibiting the prepotent response to ask for a cigarette, addressing cognitions regarding the difficulty of not smoking (i.e., cessation expectancies) and combating perceptions of the ability to smoke occasionally., (Published by Elsevier Ltd.)

Clinical trials often aggregate daily alcohol consumption data across long-term follow-up intervals (e.g., 6 or 12 months). Although important in understanding general treatment outcomes, these analyses tell us little about when treatment effects emerge or decline. We previously demonstrated that motivational interviewing (MI) reduced heavy drinking (vs. personalized feedback only; FO) among young adult drinkers (N=198; ages 18-24) recruited in a hospital emergency room (ER) using aggregated drinking data from a 6-month follow up. In the current study, we used daily alcohol consumption data from a calendar-assisted interview (Timeline Followback) to examine the timing and course of these treatment effects. Participants in both conditions received brief telephone booster sessions at 1 and 3 months. There were no treatment effects in the time between the initial intervention session and the 3-month booster session. Significant effects emerged after the 3-month booster and were driven by an increase in heavy drinking within the FO group. This suggests that the effects of brief interventions may not emerge immediately following an initial session. Aggregated data would be unable to detect this time trend. This research underscores the potential value added by examining the day-to-day timing of effects following treatments for alcohol use., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

Although typically measured with objective assessments, treatment efficacy and disease progression may also be examined using reports directly from the patient (patient-reported outcomes or PROs). PROs can enhance clinician and researcher understanding of an illness and its treatment in multiple ways, ranging from an assessment of core signs and symptoms to assessment of impairments and impacts across a variety of domains (eg, physical, social, occupational, emotional). Regulated drug and medical device development programs are increasingly using PROs as endpoints to support label claims. PRO instruments are commonly implemented in dental clinical trials. Concepts such as dental pain, tooth sensitivity, eating discomfort, and speech impairments may all be assessed via PROs. Although PROs are commonly implemented in trials, it is not clear that the development, use, and interpretation of PROs are consistent with scientific and regulatory best practices. The goals of this article were to introduce the concept of PROs and to provide an introduction to PRO scientific and regulatory principles. These principles can be used as a blueprint for using PROs in clinical research and for evaluating trials that have implemented PROs. When used appropriately, PROs may be useful in understanding the patient's perspective on illness and interventions and this perspective may be critical in fully evaluating the efficacy of dental treatments.

A behavioral economic approach to alcohol use disorders (AUDs) emphasizes both individual and environmental determinants of alcohol use. The current study examined individual differences in alcohol demand (i.e., motivation for alcohol under escalating conditions of price) and delayed reward discounting (i.e., preference for immediate small rewards compared to delayed larger rewards) in 61 heavy drinkers (62% with an AUD). In addition, based on theoretical accounts that emphasize the role of craving in reward valuation and preferences for immediate rewards, craving for alcohol was also examined in relation to these behavioral economic variables and the alcohol-related variables. Intensity of alcohol demand and delayed reward discounting were significantly associated with AUD symptoms, but not with quantitative measures of alcohol use, and were also moderately correlated with each other. Likewise, craving was significantly associated with AUD symptoms, but not with alcohol use, and was also significantly correlated with both intensity of demand and delayed reward discounting. These findings further emphasize the relevance of behavioral economic indices of motivation to AUDs and the potential importance of craving for alcohol in this relationship.

High-trait hostility is associated with persistent cigarette smoking. To better understand mechanisms that may account for this association, we examined the effects of acute smoking abstinence and delayed versus immediate smoking reinstatement on responses to a social stressor among 48 low hostile (LH) and 48 high hostile (HH) smokers. Participants completed two laboratory sessions, one before which they had smoked ad lib and one before which they had abstained for the prior 12 hr. During each session, participants completed a stressful speaking task and then smoked immediately after the stressor or after a 15-min delay. The effect of immediate versus delayed smoking reinstatement on recovery in negative mood was significantly moderated by hostility. When reinstatement was delayed, HH participants showed significant increases in negative mood over time, whereas LH participants showed little change. When reinstatement was immediate, HH and LH smokers showed similar significant decreases in negative mood. Smoking abstinence did not moderate hostility effects. Cigarette smoking may prevent continuing increases in negative mood after social stress in HH smokers, which may partially explain their low rates of quitting.

Background: Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The intent of the guidance was to describe how the FDA will evaluate the appropriateness and adequacy of PRO measures used as effectiveness end points in clinical trials. In response to the expressed need of ISPOR members for further clarification of several aspects of the draft guidance, ISPOR's Health Science Policy Council created three task forces, one of which was charged with addressing the implications of the draft guidance for the collection of PRO data using electronic data capture modes of administration (ePRO). The objective of this report is to present recommendations from ISPOR's ePRO Good Research Practices Task Force regarding the evidence necessary to support the comparability, or measurement equivalence, of ePROs to the paper-based PRO measures from which they were adapted., Methods: The task force was composed of the leadership team of ISPOR's ePRO Working Group and members of another group (i.e., ePRO Consensus Development Working Group) that had already begun to develop recommendations regarding ePRO good research practices. The resulting task force membership reflected a broad array of backgrounds, perspectives, and expertise that enriched the development of this report. The prior work became the starting point for the Task Force report. A subset of the task force members became the writing team that prepared subsequent iterations of the report that were distributed to the full task force for review and feedback. In addition, review beyond the task force was sought and obtained. Along with a presentation and discussion period at an ISPOR meeting, a draft version of the full report was distributed to roughly 220 members of a reviewer group. The reviewer group comprised individuals who had responded to an emailed invitation to the full membership of ISPOR. This Task Force report reflects the extensive internal and external input received during the 16-month good research practices development process. RESULTS/RECOMMENDATIONS: An ePRO questionnaire that has been adapted from a paper-based questionnaire ought to produce data that are equivalent or superior (e.g., higher reliability) to the data produced from the original paper version. Measurement equivalence is a function of the comparability of the psychometric properties of the data obtained via the original and adapted administration mode. This comparability is driven by the amount of modification to the content and format of the original paper PRO questionnaire required during the migration process. The magnitude of a particular modification is defined with reference to its potential effect on the content, meaning, or interpretation of the measure's items and/or scales. Based on the magnitude of the modification, evidence for measurement equivalence can be generated through combinations of the following: cognitive debriefing/testing, usability testing, equivalence testing, or, if substantial modifications have been made, full psychometric testing. As long as only minor modifications were made to the measure during the migration process, a substantial body of existing evidence suggests that the psychometric properties of the original measure will still hold for the ePRO version. Hence, an evaluation limited to cognitive debriefing and usability testing only may be sufficient. However, where more substantive changes in the migration process has occurred, confirming that the adaptation to the ePRO format did not introduce significant response bias and that the two modes of administration produce essentially equivalent results is necessary. Recommendations regarding the study designs and statistical approaches for assessing measurement equivalence are provided., Conclusions: The electronic administration of PRO measures offers many advantages over paper administration. We provide a general framework for decisions regarding the level of evidence needed to support modifications that are made to PRO measures when they are migrated from paper to ePRO devices. The key issues include: 1) the determination of the extent of modification required to administer the PRO on the ePRO device and 2) the selection and implementation of an effective strategy for testing the measurement equivalence of the two modes of administration. We hope that these good research practice recommendations provide a path forward for researchers interested in migrating PRO measures to electronic data collection platforms.

Introduction: The efficacy of contingency-management (CM) and motivational enhancement therapy (MET) for college student smoking cessation was examined., Methods: Nontreatment-seeking daily smokers (N = 110) were randomly assigned to 3 weeks of CM versus noncontingent reinforcement (NR) and to three individual sessions of MET versus a relaxation control in a 2 x 2 experimental design. Expired carbon monoxide (CO) samples were collected twice daily for 3 weeks. Participants earned 5 US dollars for providing each sample; additionally, those randomized to CM earned escalating monetary rewards based on CO reductions (Week 1) and smoking abstinence (Weeks 2-3)., Results: Compared with NR, CM resulted in significantly lower CO levels and greater total and consecutive abstinence during the intervention. Those in the CM and MET groups reported greater interest in quitting smoking posttreatment, but rates of confirmed abstinence at follow-up were very low (4% at 6-month follow-up) and did not differ by group., Discussion: Findings support the short-term efficacy of CM for reducing smoking among college students. Future research should explore enhancements to CM in this population, including a longer intervention period and the recruitment of smokers who are motivated to quit.

According to relapse models, self-efficacy (SE), or confidence in one's ability to abstain, should predict the outcome of an attempt to quit smoking. We reviewed 54 studies that prospectively examined this relationship. The relationship between SE and future smoking depended upon the population studied and the timing of the SE assessment. The relationship between SE and future smoking was modest when SE was assessed prior to a quit attempt; SE scores were .21 standard deviation units (SD) higher for those not smoking at follow-up than for those who were smoking. The relationship was stronger (.47 SD) when SE was assessed post-quit. However, this effect was diminished when only abstainers at the time of the SE assessment were included in analysis (.28 SD). Controlling for smoking status at the time of SE assessment substantially reduced the relationship between SE and future smoking. Although SE has a reliable association with future abstinence, it is less robust than expected. Many studies may overestimate the relationship by failing to appropriately control for smoking behavior at the time of the SE assessment. (PsycINFO Database Record (c) 2009 APA, all rights reserved).

Attempts to quit smoking by adolescents typically fail, even when aided by psychosocial and pharmacological treatments. Gaining a better understanding of the process of smoking cessation and relapse in this population could lead to improved treatments and increases in cessation rates. Ecological momentary assessment (EMA) has been used to describe the relapse process among adults, but not among adolescents. This study examined the feasibility of using EMA to examine relapse among adolescent smokers. Participants (N = 13) used a hand-held computer for 3 weeks to report on their smoking behavior, affect state, and exposure to smoking cues during a quit attempt (7 days prequit, 14 days postquit). All of the participants recorded a quit attempt and at least one lapse during the monitoring interval. Compliance with the protocol was generally high but decreased slightly over time. As with adults, evidence indicated that lapses were associated with craving, negative affect, and smoking cues. These data support the feasibility and potential value of using EMA with adolescent smokers.

Objectives: Patient-reported outcomes (PROs; self-report assessments) are increasingly important in evaluating medical care and treatment efficacy. Electronic administration of PROs via computer is becoming widespread. This article reviews the literature addressing whether computer-administered tests are equivalent to their paper-and-pencil forms., Methods: Meta-analysis was used to synthesize 65 studies that directly assessed the equivalence of computer versus paper versions of PROs used in clinical trials. A total of 46 unique studies, evaluating 278 scales, provided sufficient detail to allow quantitative analysis., Results: Among 233 direct comparisons, the average mean difference between modes averaged 0.2% of the scale range (e.g., 0.02 points on a 10-point scale), and 93% were within +/-5% of the scale range. Among 207 correlation coefficients between paper and computer instruments (typically intraclass correlation coefficients), the average weighted correlation was 0.90; 94% of correlations were at least 0.75. Because the cross-mode correlation (paper vs. computer) is also a test-retest correlation, with potential variation because of retest, we compared it to the within-mode (paper vs. paper) test-retest correlation. In four comparisons that evaluated both, the average cross-mode paper-to-computer correlation was almost identical to the within-mode correlation for readministration of a paper measure (0.88 vs. 0.91)., Conclusions: Extensive evidence indicates that paper- and computer-administered PROs are equivalent.

Smoking is associated with particular moods and activities, but it is not known whether there are individual differences in these associations and whether these differences are associated with success in smoking cessation. We assessed such associations using ecological momentary assessment: real-world, real-time data, collected by palm-top computer. Two hundred and fourteen smokers participating in a smoking cessation study provided data during ad lib smoking at baseline. Participants recorded moods and activities each time they smoked and, for comparison, at randomly selected non-smoking occasions. Situational associations with smoking were captured by examining the associations between smoking and antecedents considered relevant to lapse risk: negative affect (NA), arousal, socializing with others, the presence of others smoking, and consumption of coffee and alcohol. The associations varied across participants, confirming individual differences in situational smoking associations. Survival analyses revealed that only the NA pattern predicted first lapse. The effect was only seen in EMA assessments of NA smoking, and was not captured by questionnaire measures of negative affect smoking, which did not predict lapse risk. Moreover, the effect was not mediated by nicotine dependence.

Explicit expectations of the negative and positive social consequences of smoking are likely to have substantial influence on decisions regarding smoking. However, among smokers trying to quit, success in smoking cessation may be related not only to the content of expectancies about smoking's social effects but also to the ease with which these cognitive contents come to mind when confronted with smoking stimuli. To examine this possibility, we used the implicit association test (IAT) [Greenwald, A. G., McGhee, D. E., & Schwartz, J. L. K. (1998). Measuring individual differences in implicit cognition: The implicit association test. Journal of Personality and Social Psychology, 74, 1464-1480] to assess implicit cognitive associations between smoking and negative vs. positive social consequences among 67 heavy social drinkers seeking smoking cessation treatment in a randomized clinical trial. Results showed that the relative strength of implicit, negative, social associations with smoking at baseline predicted higher odds of smoking abstinence during treatment over and above the effects of relevant explicit measures. The only variable that significantly correlated with IAT scores was the density of smokers in participants' social environment; those with more smoking in their social environment showed weaker negative social associations with smoking. Results suggest implicit cognition regarding the social consequences of smoking may be a relevant predictor of smoking cessation outcome.

Aim: To establish the efficacy of a brief motivational intervention compared to feedback only when delivered in an emergency department for reducing alcohol use and problems among young adults., Design: Two-group randomized controlled trial with follow-up assessments at 6 and 12 months., Setting: Level I Trauma Center., Participants: A total of 198 18-24-year-old patients who were either alcohol positive upon hospital admission or met screening criteria for alcohol problems., Intervention: Participants were assigned randomly to receive a one-session motivational intervention (MI) that included personalized feedback, or the personalized feedback report only (FO). All participants received additional telephone contact 1 month and 3 months after baseline., Measurements: Demographic information, alcohol use, alcohol problems and treatment seeking., Findings: Six months after the intervention MI participants drank on fewer days, had fewer heavy drinking days and drank fewer drinks per week in the past month than did FO patients. These effects were maintained at 12 months. Clinical significance evaluation indicated that twice as many MI participants as FO participants reliably reduced their volume of alcohol consumption from baseline to 12 months. Reductions in alcohol-related injuries and moving violations, and increases in alcohol treatment-seeking were observed across both conditions at both follow-ups with no differences between conditions., Conclusions: This study provides new data supporting the potential of the motivational intervention tested to reduce alcohol consumption among high-risk youth.

Nicotine replacement therapy (NRT) repeatedly has been shown to improve smoking treatment outcome. The major mechanism posited for this improvement in outcome is that NRT reduces nicotine craving and withdrawal. The authors tested this hypothesized mechanism of action using real-time data on craving and withdrawal, collected by ecological momentary assessments administered on a palm-top computer. Smokers (N = 324) were randomized to receive either active high-dose (35 mg) 24-hr patches or placebo. Increases in positive affect and decreases in craving, negative affect, and attention disturbance severity were related to lower risk of lapsing. Although NRT treatment did significantly decrease withdrawal and craving severity, these reductions only partially accounted for NRT's impact on time to first lapse: The results from a mediation analysis showed that the hazard ratio for NRT, when controlling for withdrawal and craving severity, was only a third to a half lower than the uncontrolled hazard ratio for NRT alone. This suggests that other mechanisms for the effectiveness of NRT need to be examined., (((c) 2006 APA, all rights reserved).)

Tests of addiction treatments seldom reveal where treatment exercises its effect (i.e., promoting initial abstinence, preventing lapses, and/or impeding progression from lapse to relapse). The authors illustrate analyses distinguishing effects on these milestones in a randomized trial of high-dose nicotine patch (35 mg; n = 188) versus placebo (n = 136) in adult smokers, who used electronic diaries to monitor smoking in real time during 5 weeks of treatment. High-dose patch promoted initial abstinence (hazard ratio [HR] = 1.3) and decreased the risk of lapsing among those who achieved abstinence (HR = 1.6). The biggest effect of treatment was to prevent progression to relapse among those who had lapsed (HR = 7.1). Analysis of effects by milestones may enhance understanding of cessation treatments and their mechanisms of action., (Copyright 2006 APA)

The authors examined the utility of ecological momentary assessment for assessing spousal interactions in the natural environment among 245 healthy, married, older adults. Convergent validity for this method was demonstrated by (a) a positive association between marital adjustment (MA) and average diary ratings of agreeableness during spousal interactions and (b) an inverse association between MA and average diary ratings of conflict during spousal interactions. When agreeableness and conflict were examined simultaneously for spousal interactions, only agreeableness independently predicted MA. By contrast, when nonspousal interactions were examined, only conflict during nonspousal interactions was an independent predictor of MA. Results underscore the merit of obtaining representative measures of social interactions during daily life for understanding influences on and consequences of MA., (Copyright 2006 APA, all rights reserved.)

Objective and Rationale: Smoking lapses represent an important juncture between smoking cessation and relapse. Nicotine replacement therapy (NRT) has been shown to decrease the risk of progression from lapse to relapse. We hypothesized that this effect might be mediated via decreases in reinforcement from smoking lapses., Method: We assessed 169 subjects who lapsed during treatment in a double-blind placebo-controlled study of high-dose (35 mg) nicotine patch. Following their first lapse, using an electronic diary, subjects recorded the amount they smoked, and rated the pleasantness and satisfaction ("hedonic rating") and the aversiveness of smoking. Subjects were then followed and assessed for further lapses and relapses., Results: Subjects who smoked more during the first lapse had greater risk of progression [second lapse: hazard ratio (HR)=1.16, confidence interval (CI)=1.01-1.32; relapse: HR=1.22, CI=0.97-1.54]. Subjects with higher hedonic ratings of the first lapse also had a greater risk of progression to the second lapse (HR=1.08, CI=1.02-1.14) and to relapse (HR=1.26, CI=1.11-1.41). Aversive ratings had no bearing on progression. As expected, active treatment reduced the risk of both a second lapse (HR=0.54, CI=0.39-0.78) and a relapse (HR=0.22, CI=0.11-0.45). Importantly, however, NRT had no effect on hedonic ratings, amount smoked during the first lapse, or aversive ratings., Conclusions: Hedonic response to an initial lapse predicted progression to relapse, but this did not mediate the effect of NRT on progression.

Rationale: Decreasing withdrawal and craving during smoking cessation is a major aim of cessation medications. Prior studies have shown that Nicotine Replacement Therapy (NRT) decreases withdrawal symptom severity but have relied on retrospective reports and lacked robust measures of baseline symptoms or symptoms during unmedicated abstinence., Objectives and Methods: We tested the effect of high-dose (35 mg) nicotine patch on withdrawal and craving during abstinence using real-time assessment with electronic diaries during ad libitum smoking, a brief period of experimentally directed trial abstinence, and the first 3 days of cessation. Subjects were 324 smokers randomized to high-dose nicotine patches or placebo., Results: Treatment with active patches reduced withdrawal and craving during cessation and completely eliminated deprivation-related changes in affect or concentration., Conclusion: High-dose NRT reduces withdrawal symptoms and craving and can eliminate some symptoms entirely.

According to social learning models of drug relapse, decreases in abstinence self-efficacy (ASE) and increases in positive smoking outcome expectancies (POEs) should foreshadow lapses and relapse. In this study, the authors examined this hypothesis by using ecological momentary assessment data from 305 smokers who achieved initial abstinence from smoking and monitored their smoking and their ASE and POEs by using palmtop computers. Daily ASE and POEs predicted the occurrence of a 1st lapse on the following day. Following a lapse, variations in daily ASE predicted the onset of relapse, even after controlling for concurrent smoking. ASE and POEs generally neither mediated nor moderated each other's effects. These data emphasize the role of dynamic factors in the relapse process., (Copyright (c) 2005 APA, all rights reserved.)

Little is known about the situations that are associated with changes in self-efficacy during an attempt to quit smoking. In this study, 214 smokers used palmtop computers to record momentary self-efficacy ratings and situational context during a quit attempt. Higher urge to smoke and negative affect were associated with reduced self-efficacy. Although alcohol and coffee consumption are associated with heightened lapse risk, they were unrelated to abstinence self-efficacy. Individuals with low baseline self-efficacy generally reported lower self-efficacy across situations, but these differences were more pronounced under conditions of high urge and negative affect. These results suggest that self-efficacy may be reactive to affect-motivational states during a quit attempt. Whether these influences represent cognitive biases or objective risk assessments is not known., (Copyright (c) 2005 APA, all rights reserved.)

Cue exposure paradigms have been used to examine reactivity to smoking cues. However, it is not known whether cue-provoked craving is associated with smoking cessation outcomes or whether cue reactivity can be attenuated by nicotine replacement therapy (NRT) in clinical samples. Cue-provoked craving ratings and reaction time responses were measured on the 1st day of abstinence among 158 smokers who had been randomized to high-dose nicotine (35 mg) or placebo patch. The nicotine patch reduced overall levels of craving but did not attenuate cue-provoked craving increases or reaction time responses. Cue-provoked craving predicted relapse among participants on the nicotine patch but not among those on placebo. In summary, NRT users could benefit from treatment that attenuates cue-provoked craving., (Copyright 2004 APA.)

Nicotine and alcohol may have common neurobiological mechanisms of reinforcement. Therefore, withholding one substance might result in compensatory increases in self-administration of the other. This laboratory study investigated the effects of brief tobacco deprivation on alcohol cue-elicited urges to drink, corresponding psychophysiological reactions, and alcohol consumption. Young adults (N=78) who were moderate to heavy smokers and drinkers were stratified and randomized to a 2 x 2 design. Participants were either deprived of tobacco for 5 h or not deprived and then exposed to in vivo alcohol or control beverage cues. Subsequently, participants engaged in a taste-rating task as an unobtrusive measure of alcohol consumption. Tobacco deprivation resulted in increased urge to smoke and decreased cardiovascular responses but did not increase alcohol urges or alcohol consumption. Results indicate that brief tobacco deprivation does not result in compensatory increases in alcohol consumption among young moderate to heavy drinkers., (Copyright 2004 Elsevier Ltd.)

This paper is part of a series that has the goal of identifying potential approaches toward developing new instruments for assessing tobacco dependence among adolescents. The fundamental assumption underlying the series is that contemporary theories of drug dependence offer a rich source of opportunities for the development of theoretically based assessment tools. The present paper focuses on cognitive and social-learning models of drug dependence and the implications of these models for novel assessment instruments. In particular, the paper focuses on Mark Goldman's model of drug expectancies, Albert Bandura's model of self-efficacy, Thomas Wills's model of stress and coping and Stephen Tiffany's cognitive-processing model of drug urges and cravings. In addition to traditional self-report measures, naturalistic and laboratory-based assessments are identified that may yield information relevant to multi-dimensional measurement of tobacco dependence.

Theory suggests that cigarette smoking is under stimulus control and that affect is a key trigger for smoking. A previous study (S. Shiftman et al., 2002) showed little relationship between affect and smoking, but this relationship could have been suppressed by the impact of smoking restrictions. The study evaluated these associations in a 1988 sample that was subject to few smoking restrictions. Smokers (N = 28) not seeking treatment used palmtop computers to record context and affect prior to smoking (n = 2217 observations) and also at random times when not smoking (n = 2,380). Comparisons showed little relationship between smoking and affect. Smoking was associated with particular activities and locations. Urge to smoke was the strongest predictor of smoking. The results replicated the findings of S. Shiffman et al. (2002).

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.

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.