Tobacco Withdrawal Symptoms Before and After Nicotine Deprivation in Veteran Smokers with Posttraumatic Stress Disorder and with Major Depressive Disorder.

INTRODUCTION: The high smoking prevalence amongst individuals with psychiatric disorders constitutes a major public health disparity. Negative reinforcement models of addiction posit that severe tobacco withdrawal symptoms, related to the affective vulnerabilities of these smokers, may thwart their quitting smoking successfully. However, relatively few studies have prospectively examined the effects of nicotine deprivation on withdrawal symptoms in these groups. METHODS: This study compared the level of withdrawal symptoms both before and after nicotine deprivation in those diagnosed with posttraumatic stress disorder (PTSD) or major depressive disorder (MDD) and in those without psychiatric diagnoses. Participants were US veterans who smoked (≥10 cigarettes/day) and met diagnostic criteria for PTSD (n = 38), MDD (n = 43), or no psychiatric diagnosis ("controls" n = 44). Participants attended study visits before and during 48-hour nicotine deprivation to report tobacco withdrawal symptoms. Analyses evaluated withdrawal symptom levels (baseline and during nicotine deprivation) and the change in symptoms related to nicotine deprivation and compared (1) participants with a psychiatric diagnosis versus controls, and (2) participants with PTSD versus MDD. RESULTS: Contrary to hypotheses, nicotine deprivation produced greater increases in most withdrawal symptoms amongst controls than in those with psychiatric diagnoses. Compared with controls, those with PTSD or MDD reported elevated symptom levels both before and after tobacco deprivation for most withdrawal symptoms. CONCLUSIONS: These findings suggest that chronically high levels of distress and craving, rather than acute increases in withdrawal symptoms because of nicotine deprivation, may account for the quitting difficulties of those with comorbid conditions such as PTSD and MDD. IMPLICATIONS: Severe tobacco withdrawal may account for the higher quitting difficulties of smokers with either posttraumatic stress disorder (PTSD) or major depressive disorder (MDD). Paradoxically, this study showed that individuals with no psychiatric diagnosis had greater increases in tobacco withdrawal severity because of nicotine deprivation than did those with either PTSD or MDD. Those with either PTSD or MDD showed high stable levels of withdrawal symptom severity both before and during two days of abstinence, suggesting that their quitting difficulties may be related to their chronically high levels of distress rather than nicotine deprivation per se.

Possible New Symptoms of Tobacco Withdrawal III: Reduced Positive Affect-A Review and Meta-analysis.

INTRODUCTION: Most descriptions of tobacco withdrawal have not changed in >30 years despite new research. This meta-analysis tested whether abstinence leads to decreased positive affect (PA) because abstinence-induced symptom changes are a core feature of the tobacco withdrawal syndrome. In addition, we examined whether reduced PA was due to withdrawal (ie, temporary decrease in a "U-shaped" curve) or offset (ie, return to baseline) effect. METHODS: Our main inclusion criterion was a prospective within-participant test of change in PA during abstinence conditions among people who smoke cigarettes daily who were not using a cessation medication. Our search of PubMed, PsycINFO, and personal libraries yielded a total of 32 tests with 2054 participants. RESULTS: There was a medium effect size indicating an overall decrease in PA following abstinence from cigarettes (Cohen's d = -0.40, 95% CI = -0.30 to -0.49). There was large heterogeneity (I2 = 70.7%). Most (79%) of the 24 trials that conducted significance tests reported that reduction in PA was significant. Seven tests were adequately designed to detect a withdrawal versus offset effect. Over half (57%) displayed a U-shaped curve for abstinence-induced change in PA indicative of a withdrawal symptom rather than offset effect. CONCLUSIONS: Abstinence from cigarettes is associated with a decrease in PA. Whether low PA should be added to withdrawal measures and diagnostic criteria requires replication of the time-course of change in PA and tests of whether abstinence-induced changes in PA and negative affect occur independently. IMPLICATIONS: Though there was substantial heterogeneity among trials, our findings suggest that (1) abstinence from cigarettes decreases positive affect and (2) this decrease may represent a withdrawal effect (vs. an offset effect). However, it is unclear whether abstinence-induced losses in positive affect are independent from increased negative affect.

Anxiety Sensitivity and Distress Tolerance in Smokers: Relations With Tobacco Dependence, Withdrawal, and Quitting Success†.

INTRODUCTION: This study examined relations of two affective vulnerabilities, high anxiety sensitivity (AS) and low distress tolerance (DT), with tobacco dependence, withdrawal, smoking cessation, and pharmacotherapy response. METHODS: Smokers interested in quitting (N = 1067; 52.2% female, 28.1% African American) were randomized to 12 weeks of nicotine patch, nicotine patch plus nicotine lozenge, or varenicline. Baseline questionnaires assessed AS, DT, negative affect, anxiety, and dependence. Withdrawal was assessed the first-week post-quit via ecological momentary assessment. RESULTS: DT, but not AS, predicted biochemically confirmed point-prevalence abstinence at multiple endpoints: weeks 4, 12, 26, and 52 post-quit (ps < .05); relations remained after controlling for pharmacotherapy treatment, AS, baseline negative affect, anxiety, and anxiety disorder history (ps < .05). Additional exploratory analyses examining week 4 abstinence showed DT predicted abstinence (p = .004) even after controlling for baseline dependence, post-quit withdrawal (craving and negative affect), and treatment. DT moderated treatment effects on abstinence in exploratory analyses (interaction p = .025); those with high DT were especially likely to be abstinent at week 4 with patch plus lozenge versus patch alone. CONCLUSIONS: DT, but not AS, predicted abstinence over 1 year post-quit (higher DT was associated with higher quit rates), with little overlap with other affective measures. DT also predicted early abstinence independent of dependence and withdrawal symptoms. Results suggest low DT may play a meaningful role in motivation to use tobacco and constitute an additional affective risk factor for tobacco cessation failure beyond negative affect or clinical affective disorders. IMPLICATIONS: People in a stop-smoking study who reported a greater ability to tolerate distress were more likely to quit smoking and remain smoke-free 1 year later. Smokers with high DT were more likely to be smoke-free 4 weeks after their target quit day if they received nicotine patch plus nicotine lozenge rather than nicotine patch alone. TRIAL REGISTRATION: NCT01553084.

Predictors of Smoking Cessation Attempts and Success Following Motivation-Phase Interventions Among People Initially Unwilling to Quit Smoking.

INTRODUCTION: Most people who smoke cigarettes are not willing (ie, not ready) to make a quit attempt (QA) at any given time. Unfortunately, interventions intended to increase QAs and the success of QAs are only modestly effective. Identifying processes leading to QAs and quitting success could guide intervention development. AIMS AND METHODS: This is a secondary analysis of a randomized factorial trial of 6 weeks of motivation-phase interventions among primary care patients (N = 517) who were initially unwilling to quit but were willing to reduce their smoking. Using logistic regression, we controlled for treatment condition and tested whether baseline or change in smoking-related constructs after 6 weeks of treatment predicted (1) making an at least 24 h QA between weeks 6 and 26 and (2) quitting success at week 26 (7-day point-prevalence abstinence among those who made a QA). Predictors included cigarettes/day, time to first cigarette, motivation to quit, quitting self-efficacy, anticipated urges to smoke if quit, positive affect, negative affect, and time spent around others who smoke. RESULTS: In multivariable models that included all smoking-related constructs, changes in the following variables predicted initiating a QA above and beyond other variables: greater baseline time to first cigarette (odds ratio [OR] = 1.60), increases in time to first cigarette (OR = 1.27), and increases in quitting self-efficacy (OR = 1.14). Increased motivation to quit predicted conversion of a QA into quitting success at 26 weeks (OR = 1.36). CONCLUSION: Predictors of making a QA differed from predictors of quitting success. Predictors of QAs and success could each serve as important treatment targets of motivation-phase interventions. IMPLICATIONS: Motivation-phase interventions for people initially unwilling to quit smoking cigarettes may be improved by striving to increase their (1) time to first cigarette and quitting self-efficacy to promote QAs and (2) motivation to quit to promote quit success. Future experimental tests of such interventions are needed to identify causal determinants of QAs and quitting success.

Electronically Monitored Nicotine Gum Use Before and After Smoking Lapses: Relationship With Lapse and Relapse.

INTRODUCTION: Greater use of nicotine replacement therapy (NRT) is related to smoking cessation success, but the causal direction is unclear. This study characterized the relationship between NRT use and smoking lapse and relapse. METHODS: Participants (N = 416 smokers; 57% female, 85% White) were recruited from primary care for a smoking cessation factorial experiment and analyzed if abstaining ≥1 day in the first 2 weeks post-target quit day (TQD). Participants were randomized to counseling and 8 versus 26 weeks of nicotine patch plus nicotine gum post-TQD. Participants carried electronic dispensers that timestamped each gum use. Participants who lapsed (smoked after abstaining) within 6 weeks post-TQD were matched with nonlapsers (n = 146 pairs) on multiple variables. We compared lapsers' versus matched nonlapsers' gum use in the 5 days before and after the lapsers' first lapse. RESULTS: By week 6 post-TQD, 63% of participants lapsed. Compared with nonlapsers, lapsers used less gum 1 and 2 days pre-"lapse" and on the 5 days post-lapse. Lapsers used less gum during the 5 days post-lapse than the 5 days pre-lapse. Univariate survival analyses with lapsers showed greater gum use during both pre- and post-lapse periods predicted longer latency to relapse in the first 6 weeks. CONCLUSIONS: In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched nonlapsers used less gum immediately preceding and following their first lapse. Lower mean gum use before and after lapses predicted a more rapid escalation to relapse. Decreased nicotine gum use both precedes and follows returns to smoking during cessation attempts. IMPLICATIONS: This research examined electronically monitored nicotine gum use collected in real time and found that among smokers engaged in a quit attempt, lapsers (vs. matched nonlapsers) tended to decrease their gum use 1-2 days prior to lapsing and to further decrease their gum use from pre- to post-lapse. Decreased gum use pre-lapse may signal heightened lapse risk in 1-2 days, with lower level of gum use predicting a more precipitous course of relapse. These results encourage further exploration of objective measures of smoking medication use patterns to examine their signaling properties and to inform understanding of cessation failure. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01120704.

Motives for Smoking in Those With PTSD, Depression, and No Psychiatric Disorder.

Objective: Approaches for effectively treating smoking in those with posttraumatic stress disorder (PTSD) and with major depressive disorder (MDD) could be improved by identifying motivational processes underlying their tobacco dependence. The goal of this study was to identify the motivational processes influencing smoking dependence among smokers with PTSD and with MDD relative to non-diagnosed controls. Methods: Participants were United States (US) veterans who smoked daily (N = 162) and met DSM-IV criteria for either PTSD (n = 52), MDD (n = 52), or no current psychiatric disorder (controls; n = 58). Smoking dependence motives were assessed via the Brief Wisconsin Inventory for Smoking Dependence Motives (Brief WISDM). The 11 Brief WISDM subscales are categorized into two major factors: Primary Dependence Motives and Secondary Dependence Motives. Results: Smokers with PTSD scored higher than non-diagnosed controls on the following Primary Dependence Motives subscales: Automaticity, Craving, and Tolerance (all p-values <.05). Smokers with PTSD, relative to controls, also scored higher on the overall Secondary Dependence Motives subscale, and on five of the seven Secondary Dependence Motives subscales: Cue Exposure/Associative Processes, Affective Enhancement, Affiliative Attachment, Cognitive Enhancement, and Weight Control (all p-values < .05). Smokers with MDD scored significantly higher than controls on one Primary Dependence Motives subscale: Craving and on four of seven Secondary Dependence Motives subscales: Affective Enhancement, Affiliative Attachment, Cognitive Enhancement, and Weight Control (all p-values <.05). Finally, exploratory analyses directly contrasting the PTSD group with the MDD group showed that smokers with PTSD were higher than those with MDD in the overall Secondary Dependence Motives subscale and one of the seven Secondary Dependence Motives subscales: Cue Exposure/Associative Processes (all p-values < .05). Conclusions: Results suggest that both Primary Dependence Motives and Secondary Dependence Motives play a meaningful role in motivation to use tobacco in smokers with PTSD; smoking dependence in those with MDD may be primarily influenced by Secondary Dependence Motives.

A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care.

Background: The effectiveness of smoking cessation treatment is limited in real-world use, perhaps because we have not selected the components of such treatments optimally nor have treatments typically been developed for and evaluated in real-world clinical settings. Purpose: To validate an optimized smoking cessation treatment package that comprises intervention components identified as effective in factorial screening experiments conducted as per the Multiphase Optimization Strategy (MOST). Methods: Adult smokers motivated to quit were recruited from primary care clinics (N = 623). Participants were randomized to receive either recommended usual care (R-UC; 10 min of in-person counseling, 8 weeks of nicotine patch, and referral to quitline services) or abstinence-optimized treatment (A-OT; 3 weeks of prequit mini-lozenges, 26 weeks of nicotine patch + mini-lozenges, three in-person and eight phone counseling sessions, and 7-11 automated calls to prompt medication use). The key outcomes were self-reported and biochemically confirmed (carbon monoxide, CO <6 ppm) 7-day point-prevalence abstinence. Results: A-OT participants had significantly higher self-reported abstinence rates than R-UC participants at 4, 8, 16, and 26 weeks (ORs: 1.91-3.05; p <. 001). The biochemically confirmed 26-week abstinence rates were lower than the self-reported 26-week rates, but revealed a similar treatment effect size (OR = 2.94, p < .001). There was no moderation of treatment effects on 26-week abstinence by demographic, psychiatric, or nicotine dependence variables. A-OT had an incremental cost-effectiveness ratio for 26-week CO-confirmed abstinence of $7,800. Conclusions: A smoking cessation treatment that is optimized via MOST development meaningfully enhances cessation rates beyond R-UC smoking treatment in smokers seen in primary care. Clinical Trial Registration: NCT02301403.

Offering smoking treatment to primary care patients in two Wisconsin healthcare systems: Who chooses smoking reduction versus cessation?

Smokers unwilling to make a quit attempt can still benefit from smoking intervention. However, it is unclear what proportion of smokers will enter such a Motivation phase intervention, and whether such an intervention attracts different types of smokers than does abstinence oriented treatment. We conducted a study from June 2010 to October 2013 based on a chronic care model of tobacco treatment among study eligible primary care patients (N=1579; 58% women, 89% White) presenting for regular health care visits in southern Wisconsin, U.S. Medical assistants, prompted via the electronic health record (EHR), invited smokers (n=10,242) to learn more about treatment options to help them either reduce their smoking or quit. Of those invited to learn more who were then reached by study staff, 10.2% (n=1046) reported interest in reduction treatment and 24% (n=2465) reported interest in cessation treatment. Patients who selected and ultimately entered reduction (n=492) versus cessation (n=1087) were more likely to report: older age; a history of anxiety; lower motivation to quit; lower primary dependence motives; more close friends or family who smoke; and a greater interval since their last quit attempt. Results suggest that Motivation phase treatment aimed at smoking reduction may increase the proportion and range of smokers inducted into tobacco treatment.

Anhedonia: Its Dynamic Relations With Craving, Negative Affect, and Treatment During a Quit Smoking Attempt.

INTRODUCTION: Research shows that abstinence from tobacco leads to a withdrawal-related decrement in responsivity to nondrug rewards (ie, anhedonia). However, it remains unclear how anhedonia relates to other key withdrawal symptoms and withdrawal-related constructs over time. We analyzed ecological momentary assessment data to examine whether a decrement in response to rewards during a 10-day period following quitting shows a pattern of associations with other variables (ie, treatment, tobacco dependence, negative affect, and craving) that is consistent with anhedonia being a tobacco withdrawal symptom. METHODS: As part of a randomized controlled trial of smoking cessation therapies, 1122 adults (58% female) were assigned to: placebo (n = 131), bupropion (alone or with nicotine lozenge; n = 401), or nicotine replacement therapy (NRT; lozenge, patch, both; n = 590). Participants completed 4 ecological momentary assessments per day for 10 days postquit, resulting in 22 575 assessments. RESULTS: Time-varying effect modeling showed that anhedonia was significantly greater among those high in dependence relative to lower dependent smokers out to day 9 postquit. The placebo group showed elevated anhedonia immediately postquit, which fell to levels similar to the treatment groups by day 7. NRT effectively reduced anhedonia and its time-varying association with craving early in the quit attempt. The positive association between negative affect and anhedonia was moderate and stable over time for both active treatment groups. CONCLUSIONS: These results provide additional support that anhedonia following quitting smoking is a manifestation of the tobacco withdrawal syndrome. IMPLICATIONS: This study supported the hypothesis that diminished responsivity to nondrug rewards (ie, anhedonia) is a symptom of the tobacco withdrawal syndrome. Results showed that anhedonia: (1) was significantly associated with dependence, especially during the early postquit period when withdrawal was at its peak intensity; (2) showed significant time-varying associations with other withdrawal symptoms, especially craving; and (3) was significantly suppressed by agonist administration as was its association with craving over time.

Pharmacological, sensorimotor, and expectancy effects on tobacco withdrawal: a preliminary study.

OBJECTIVE: Research designs for parsing the mechanisms underlying tobacco withdrawal are scant. This study introduced a novel research design that simultaneously manipulated three tobacco withdrawal mechanisms: pharmacological (nicotine dissipation), sensorimotor (elimination of the smoking ritual), and expectancy (activation of beliefs regarding the effects of nicotine deprivation), permitting examination of the effects of each mechanism while holding the other two mechanisms constant. METHODS: Following overnight abstinence, 32 regular cigarette smokers were randomized in a 2 (expectancy: told patch contains nicotine versus told placebo patch) × 2 (drug: receive 21-mg transdermal nicotine patch versus receive placebo patch) × 2 (sensorimotor: smoke very low nicotine content cigarettes versus no smoking) full factorial between-subjects design. Participants repeatedly completed measures of craving, affect, and anticipated pleasure from and desire for rewarding experiences, followed by a smoking lapse analog task. RESULTS: Receiving nicotine (versus placebo) increased positive affect and anticipated pleasure from and desire for reward. Expecting nicotine (versus placebo) reduced negative affect and increased smoking delay. Sensorimotor stimulation from smoking (versus no smoking) reduced smoking urge and behavior. CONCLUSION: Results provided initial validation of this novel three-mechanism design. This design can be used in the future to advance understanding and treatment of tobacco withdrawal.

Post-traumatic stress disorder symptoms, underlying affective vulnerabilities, and smoking for affect regulation.

BACKGROUND AND OBJECTIVES: Post-traumatic stress disorder (PTSD) is overrepresented among cigarette smokers. It has been hypothesized that those with PTSD smoke to alleviate negative affect and counteract deficient positive affect commonly associated with the disorder; however, limited research has examined associations between PTSD symptoms, smoking motives, and affective vulnerability factors. In the current study, we examined (1) whether PTSD symptoms were associated with positive reinforcement and negative reinforcement smoking motives; and (2) whether two affective vulnerability factors implicated in PTSD-anxiety sensitivity and anhedonia-mediated relationships between PTSD symptoms and smoking motives. METHODS: Data were drawn from a community sample of non-treatment-seeking smokers recruited without regard for trauma history (N = 342; 10+ cig/day). We used the Posttraumatic Stress Disorder Checklist-Civilian Version (PCL-C) to assess overall PTSD symptom severity as well as individual PTSD subfactors. RESULTS: Overall, PTSD symptom severity was significantly associated with negative reinforcement, but not positive reinforcement, smoking motives. Variation in anxiety sensitivity significantly mediated the relation between PTSD symptom severity and negative reinforcement smoking motives, whereas anhedonia did not. Regarding PTSD subfactors, emotional numbing was the only PTSD subfactor associated with smoking rate, while re-experiencing symptoms were uniquely associated with both positive reinforcement and negative reinforcement smoking motives. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Findings suggest that anxiety sensitivity may be an important feature associated with PTSD that enhances motivation to smoke for negative reinforcement purposes. Smoking cessation interventions that alleviate anxiety sensitivity and enhance coping with negative affect may be useful for smokers with elevated PTSD symptoms.

What to do after smoking relapse? A sequential multiple assignment randomized trial of chronic care smoking treatments.

AIM: To compare effects of three post-relapse interventions on smoking abstinence. DESIGN: Sequential three-phase multiple assignment randomized trial (SMART). SETTING: Eighteen Wisconsin, USA, primary care clinics. PARTICIPANTS: A total of 1154 primary care patients (53.6% women, 81.2% White) interested in quitting smoking enrolled from 2015 to 2019; 582 relapsed and were randomized to relapse recovery treatment. INTERVENTIONS: In phase 1, patients received cessation counseling and 8 weeks nicotine patch. Those who relapsed and agreed were randomized to a phase 2 relapse recovery group: (1) reduction counseling + nicotine mini-lozenges + encouragement to quit starting 1 month post-randomization (preparation); (2) repeated encouragement to quit starting immediately post-randomization (recycling); or (3) advice to call the tobacco quitline (control). The first two groups could opt into phase 3 new quit treatment [8 weeks nicotine patch + mini-lozenges plus randomization to two treatment factors (skill training and supportive counseling) in a 2 × 2 design]. Phase 2 and 3 interventions lasted ≤ 15 months. MEASUREMENTS: The study was powered to compare each active phase 2 treatment with the control on the primary outcome: biochemically confirmed 7-day point-prevalence abstinence 14 months post initiating phase 2 relapse recovery treatment. Exploratory analyses tested for phase 3 counseling factor effects. FINDINGS: Neither skill training nor supportive counseling (each on versus off) increased 14-month abstinence rates; skills on versus off 9.3% (14/151) versus 5.2% (8/153), P = 0.19; support on versus off 6.6% (10/152) versus 7.9% (12/152), P = 0.73. Phase 2 preparation did not produce higher 14-month abstinence rates than quitline referral; 3.6% (8/220) versus 2.1% [3/145; risk difference = 1.5%, 95% confidence interval (CI) = -1.8-5.0%, odds ratio (OR) = 1.8, 95% CI = 0.5-6.9]. Recycling, however, produced higher abstinence rates than quitline referral; 6.9% (15/217) versus 2.1% (three of 145; risk difference, 4.8%, 95% CI = 0.7-8.9%, OR = 3.5, 95% CI = 1.0-12.4). Recycling produced greater entry into new quit treatment than preparation: 83.4% (181/217) versus 55.9% (123/220), P < 0.0001. CONCLUSIONS: Among people interested in quitting smoking, immediate encouragement post-relapse to enter a new round of smoking cessation treatment ('recycling') produced higher probability of abstinence than tobacco quitline referral. Recycling produced higher rates of cessation treatment re-engagement than did preparation/cutting down using more intensive counseling and pharmacotherapy.

Life 1 year after a quit attempt: real-time reports of quitters and continuing smokers.

BACKGROUND: Smokers are often reluctant to quit because they fear long-lasting withdrawal. Yet little research prospectively examines smokers' withdrawal longer than 1 month post-quit. PURPOSE: The aim of this study was to compare successful versus unsuccessful quitters' withdrawal, positive affect/pleasure, and lifestyle at 1 year post-quit. METHODS: Smokers (N = 572) in a cessation trial completed ecological momentary assessments four times a day for 1 week pre-quit, 1 week post-quit, and 1 week at 1 year post-quit. RESULTS: From pre-quit to 1 year later, only quitters reported sizeable declines in craving and restlessness, and fewer stressful events. At 1 year, quitters, on average, reported no significant craving. Continuing smokers reduced their cigarette consumption considerably from pre-quit to 1 year later. CONCLUSIONS: Contrary to smokers' worries, long-term quitters reported less craving and restlessness than when they smoked (perhaps because cessation eliminates the acute nicotine withdrawal smokers experience between cigarettes). This information may encourage smokers to quit and endure withdrawal.

Smoking outcome expectancies in military veteran smokers with posttraumatic stress disorder.

INTRODUCTION: Smoking outcome expectancies were investigated in treatment-seeking military Veteran smokers with posttraumatic stress disorder (PTSD). The investigation of smoking outcome expectancies may enhance our understanding of the relationship between PTSD and cigarette smoking. METHODS: Participants were 943 military Veterans with a diagnosis of PTSD who were current smokers enrolled in a randomized multisite effectiveness trial to test whether the integration of smoking cessation treatment into mental health care (integrated care) improves prolonged abstinence rates compared with referral to specialized smoking cessation clinics (usual care). Using confirmatory factor analysis (CFA), we evaluated the conceptual model of smoking outcome expectancies measured on the Smoking Consequences Questionnaire-Adult (SCQ-A) version. The Kraemer method of mediation analysis was used to investigate the role of smoking outcome expectancies in mediating relationships between PTSD symptoms and smoking behavior, tobacco dependence, and abstinence self-efficacy. RESULTS: The CFA supported the 10-factor structure of the SCQ-A in smokers with PTSD. Relationships between measures of PTSD symptoms and tobacco dependence were mediated by the smoking outcome expectancy regarding negative affect reduction. This same smoking outcome expectancy mediated relationships between PTSD symptoms and smoking abstinence self-efficacy. CONCLUSIONS: The findings support the use of the SCQ-A as a valid measure of smoking outcome expectancies in military Veteran smokers with PTSD. Moreover, they suggest that smoking outcome expectancies may play an important role in explaining the relationship between PTSD and cigarette smoking.

Should all smokers use combination smoking cessation pharmacotherapy? Using novel analytic methods to detect differential treatment effects over 8 weeks of pharmacotherapy.

INTRODUCTION: Combination pharmacotherapy for smoking cessation has been shown to be more effective than monotherapy in meta-analyses. We address the question of whether combination pharmacotherapy should be used routinely with smokers or if some types of smokers show little or no benefit from combination pharmacotherapy versus monotherapy. METHODS: Two smoking cessation trials were conducted using the same assessments and medications (bupropion, nicotine lozenge, nicotine patch, bupropion + lozenge, and patch + lozenge). Participants were smokers presenting either to primary care clinics in southeastern Wisconsin for medical treatment (Effectiveness trial, N = 1,346) or volunteering for smoking cessation treatment at smoking cessation clinics in Madison and Milwaukee, WI (Efficacy trial, N = 1,504). For each trial, decision tree analyses identified variables predicting outcome from combination pharmacotherapy versus monotherapy at the end of treatment (smoking 8 weeks after the target quit day). RESULTS: All smokers tended to benefit from combination pharmacotherapy except those low in nicotine dependence (longer latency to smoke in the morning as per item 1 of the Fagerström Test of Nicotine Dependence) who also lived with a spouse or partner who smoked. CONCLUSIONS: Combination pharmacotherapy was generally more effective than monotherapy among smokers, but one group of smokers, those who were low in nicotine dependence and who lived with a smoking spouse, did not show greater benefit from using combination pharmacotherapy. Use of monotherapy with these smokers might be justified considering the expense and side effects of combination pharmacotherapy.

The multiphase optimization strategy for engineering effective tobacco use interventions.

The multiphase optimization strategy (MOST) is a new methodological approach for building, optimizing, and evaluating multicomponent interventions. Conceptually rooted in engineering, MOST emphasizes efficiency and careful management of resources to move intervention science forward steadily and incrementally. MOST can be used to guide the evaluation of research evidence, develop an optimal intervention (the best set of intervention components), and enhance the translation of research findings, particularly type II translation. This article uses an ongoing study to illustrate the application of MOST in the evaluation of diverse intervention components derived from the phase-based framework reviewed in the companion article by Baker et al. (Ann Behav Med, in press, 2011). The article also discusses considerations, challenges, and potential benefits associated with using MOST and similar principled approaches to improving intervention efficacy, effectiveness, and cost-effectiveness. The applicability of this methodology may extend beyond smoking cessation to the development of behavioral interventions for other chronic health challenges.

New methods for tobacco dependence treatment research.

INTRODUCTION: Despite advances in tobacco dependence treatment in the past two decades, progress has been inconsistent and slow. This paper reviews pervasive methodological issues that may contribute to the lack of timely progress in tobacco treatment science including the lack of a dynamic model or framework of the cessation process, inefficient study designs, and the use of distal outcome measures that poorly index treatment effects. The authors then present a phase-based cessation framework that partitions the cessation process into four discrete phases based on current theories of cessation and empirical data. These phases include: (1) Motivation, (2) Precessation, (3) Cessation, and (4) Maintenance. DISCUSSION: Within this framework, it is possible to identify phase-specific challenges that a smoker would encounter while quitting smoking, intervention components that would address these phase-specific challenges, mechanisms via which such interventions would exert their effects, and optimal outcome measures linked to these phase-specific interventions. Investigation of phase-based interventions can be accelerated by using efficient study designs that would permit more timely development of an optimal smoking cessation treatment package.

Time-varying effects of 'optimized smoking treatment' on craving, negative affect and anhedonia.

AIMS: To identify when smoking cessation treatments affect craving, negative affect and anhedonia, and how these symptoms relate to abstinence, to help evaluate the effects of particular intervention components in multi-component treatments and accelerate treatment refinement. DESIGN: Secondary analysis of data from a two-arm randomized controlled trial. SETTING: Seven primary care clinics in Wisconsin, United States. PARTICIPANTS: Adult primary care patients who smoked daily (n = 574). INTERVENTION AND COMPARATOR: Intervention was abstinence-optimized treatment (A-OT, n = 276) comprising 3 weeks of nicotine mini-lozenges pre-target quit day (TQD), 26 weeks of combination nicotine patch and mini-lozenges post-TQD and extensive psychosocial support. The comparator was recommended usual care (RUC, n = 298), comprising brief counseling and 8 weeks of nicotine patch post-TQD. MEASUREMENTS: Time-varying effect models examined dynamic effects of A-OT (versus RUC) on the primary outcomes of nightly cigarette craving, negative affect and anhedonia from 1 week pre- to 2 weeks post-TQD. Exploratory models examined within-person relations between nicotine medication use and same-day symptom ratings. Secondary logistic regression analyses examined associations between post-TQD craving, negative affect and anhedonia and 1-month post-TQD abstinence. FINDINGS: A-OT significantly suppressed pre- and post-TQD craving (ß = -0.27 to -0.46 across days) and post-TQD anhedonia (ß = -0.24 to -0.38 across days), relative to RUC. Within individuals, using patches was associated with lower negative affect in RUC (ß = -0.42 to -0.52), but not in A-OT. Using more mini-lozenges was associated with greater craving (ß = 0.04-0.07) and negative affect (ß = 0.03-0.05) early, and with lower anhedonia (ß = -0.06 to -0.12) later. Greater post-TQD craving (OR = 0.68) and anhedonia (OR = 0.85) predicted lower odds of abstinence 1 month post-TQD. CONCLUSION: Time-varying effect models showed that a multi-component treatment intervention for smoking cessation suppressed significant withdrawal symptoms more effectively than recommended usual care among daily adult smokers motivated to quit. The intervention reduced craving pre- and post-target quit day (TQD) and anhedonia post-TQD.

Evaluating four motivation-phase intervention components for use with primary care patients unwilling to quit smoking: a randomized factorial experiment.

AIMS: To assess the effectiveness of intervention components designed to increase quit attempts and promote abstinence in patients initially unwilling to quit smoking. DESIGN: A four-factor, randomized factorial experiment. SETTING: Sixteen primary care clinics in southern Wisconsin. PARTICIPANTS: A total of 577 adults who smoke (60% women, 80% White) recruited during primary care visits who were currently willing to reduce their smoking but unwilling to try to quit. Interventions Four factors contrasted intervention components administered over a 1-year period: (i) nicotine mini-lozenge versus none; (ii) reduction counseling versus none; (iii) behavioral activation (BA) counseling versus none; and (iv) motivational 5Rs counseling versus none. Participants could request cessation treatment at any time. MEASUREMENTS: The primary outcome was 7-day point-prevalence abstinence at 52 weeks post enrollment; secondary outcomes were point-prevalence abstinence at 26 weeks and making a quit attempt by weeks 26 and 52. FINDINGS: No abstinence main effects were found but a mini-lozenge × reduction counseling × BA interaction was found at 52 weeks; P = 0.03. Unpacking this interaction showed that the mini-lozenge alone produced the highest abstinence rate (16.7%); combining it with reduction counseling produced an especially low abstinence rate (4.1%). Reduction counseling decreased the likelihood of making a quit attempt by 52 weeks relative to no reduction counseling (P = 0.01). CONCLUSIONS: Nicotine mini-lozenges may increase smoking abstinence in people initially unwilling to quit smoking, but their effectiveness declines when used with smoking reduction counseling or other behavioral interventions. Reduction counseling decreases the likelihood of making a quit attempt in people initially unwilling to quit smoking.

Does PTSD moderate the relationship between social support and suicide risk in Iraq and Afghanistan War Veterans seeking mental health treatment?

OBJECTIVE: This study examined posttraumatic stress disorder (PTSD) as a potential moderating variable in the relationship between social support and elevated suicide risk in a sample of treatment-seeking Iraq and Afghanistan War Veterans. METHOD: As part of routine care, self-reported marital status, satisfaction with social networks, PTSD, and recent suicidality were assessed in Veterans (N=431) referred for mental health services at a large Veteran Affairs Medical Center. Logistic regression analyses were conducted using this cross-sectional data sample to test predictions of diminished influence of social support on suicide risk in Veterans reporting PTSD. RESULTS: Thirteen percent of Veterans were classified as being at elevated risk for suicide. Married Veterans were less likely to be at elevated suicide risk relative to unmarried Veterans and Veterans reporting greater satisfaction with their social networks were less likely to be at elevated risk relative to Veterans reporting lower satisfaction. Satisfaction with social networks was protective for suicide risk in PTSD and non-PTSD cases, but was significantly less protective for veterans reporting PTSD. CONCLUSIONS: Veterans who are married and Veterans who report greater satisfaction with social networks are less likely to endorse suicidal thoughts or behaviors suggestive of elevated suicide risk. However, the presence of PTSD may diminish the protective influence of social networks among treatment-seeking Veterans.