Differential Posttreatment Outcomes of Methylphenidate for Smoking Cessation for Individuals With ADHD.

BACKGROUND AND OBJECTIVES: In a multisite, randomized study (CTN-0029), a 3-month course of Osmotic-Release Oral System Methylphenidate (OROS-MPH) improved smoking cessation in a group of patients with higher baseline severity in Attention-Deficit/Hyperactivity Disorder (ADHD). This treatment, however, worsened smoking cessation outcome in the group with lower baseline ADHD severity. We want to examine whether this differential treatment effect persisted after OROS-MPH was discontinued. METHODS: We conducted a secondary analysis of the 1-month follow-up data from CTN-0029 after the discontinuation of OROS-MPH (N = 134). Nicotine patch was tapered during this month. We tested whether OROS-MPH had an effect on self-reported 7-day abstinence by week, as well as possible treatment by baseline ADHD severity interactions. RESULTS: Abstinence diminished overall in time after the end of the treatment. In the high baseline severity group, patients who received OROS-MPH had an advantage in 7-day abstinence at week 15 (40% for OROS-MPH vs 20% for placebo, odds ratio = 2.63, P = .028). In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups. There was also a significant treatment by baseline ADHD severity interaction (P = .03). CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: OROS-MPH promotes abstinence beyond the course of treatment for patients with more severe ADHD, while the paradoxical effects in the lower baseline severity group is not persistent after medication discontinuation. Targeting ADHD in smoking cessation as a comorbidity therefore can have broader impact with more precise patient selection. (Am J Addict).

Toward personalized smoking-cessation treatment: Using a predictive modeling approach to guide decisions regarding stimulant medication treatment of attention-deficit/hyperactivity disorder (ADHD) in smokers.

BACKGROUND AND OBJECTIVES: Osmotic-release oral system methylphenidate (OROS-MPH) did not show overall benefit as an adjunct smoking cessation treatment for adult smokers with ADHD in a randomized, placebo-controlled, multicenter clinical trial. A secondary analysis revealed a significant interaction between ADHD symptom severity and treatment-response to OROS-MPH, but did not account for other baseline covariates or estimate the magnitude of improvement in outcome if treatment were optimized. This present study addressed the gaps in how this relationship should inform clinical practice. METHODS: Using data from the Adult Smokers with ADHD Trial (N = 255, six sites in five US States), we build predictive models to calculate the probability of achieving prolonged abstinence, verified by self-report, and expired carbon monoxide measurement. We evaluate the potential improvement in achieving prolonged abstinence with and without stratification on baseline ADHD severity. RESULTS: Predictive modeling demonstrates that the interaction between baseline ADHD severity and treatment group is not affected by adjusting for other baseline covariates. A clinical trial simulation shows that giving OROS-MPH to patients with baseline Adult ADHD Symptom Rating Scale (ADHD-RS) >35 and placebo to those with ADHD-RS ≤35 would significantly improve the prolonged abstinence rate (52 ± 8% vs. 42 ± 5%, p < .001). CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: In smokers with ADHD, utilization of a simple decision rule that stratifies patients based on baseline ADHD severity can enhance overall achievement of prolonged smoking abstinence. Similar analysis methods should be considered for future clinical trials for other substance use disorders.

Duration of smoking abstinence and suicide-related outcomes.

OBJECTIVE: To investigate the association between suicide-related outcomes (SROs: wish to die, suicidal thoughts, and attempted suicide) and duration of smoking abstinence. METHODS: The National Epidemiologic Survey on Alcohol and Related Conditions Wave 1 is a face-to-face survey of a representative sample of the U.S. adult population (N = 43,093). Analyses were done for a subsample of individuals (N = 13,691) who reported ever smoking, at least 2 weeks of lifetime depressed mood and SROs. Duration of abstinence was categorized as 1-24 hr (reference), 1 day to 12 months, and longer than 12 months. RESULTS: Univariate analyses showed significant demographic associations (positive: female gender and being widowed/divorced/separated; negative: age and household income) with SROs. SROs were positively associated with major psychiatric disorders (dysthymia, major depression, generalized anxiety disorders, antisocial personality disorder, nicotine dependence, and alcohol abuse/dependence). Logistic regression showed that nonsmoking for more than a year compared with less than 24 hr (nonabstinence) was significantly associated with reduced risk for wish to die (odds ratio [OR]: 0.56, 95% CI: 0.49-0.65), suicidal thoughts (OR: 0.54, 95% CI: 0.48-0.62), and attempted suicide (OR: 0.32, 95 % CI: 0.26-0.41). With adjustments for lifetime psychiatric disorders, duration of abstinence was no longer significantly associated with the SROs. CONCLUSIONS: In the sample of ever-smokers with lifetime depressed mood, an apparent protective effect of increased duration of smoking abstinence on susceptibility to suicidal behavior was neutralized by the presence of psychiatric disorders. The causal direction of these relationships is unclear, and these cross-sectional findings need confirmation in future prospective studies.

Divergence by ADHD subtype in smoking cessation response to OROS-methylphenidate.

INTRODUCTION: Attention deficit hyperactivity disorder (ADHD) is a neuropsychiatric condition subclassified in DSM-IV according to its core symptoms domains as (a) predominantly inattentive (ADHD-IN), (b) predominantly hyperactive/impulsive (ADHD-H), and (c) combined inattentive and hyperactive/impulsive (ADHD-C). Whether these subtypes represent distinct clinical entities or points on a severity continuum is controversial. Divergence in treatment response is a potential indicator of qualitative heterogeneity. This study examined smoking cessation response by ADHD subtype to osmotic-release oral system methylphenidate (OROS-MPH). METHODS: Male and female adult smokers (ADHD-C = 167 and ADHD-IN = 87) were randomized to receive OROS-MPH or placebo as augmentation treatment to nicotine patch and counseling. Logistic regression was conducted to test the effect of OROS-MPH versus placebo on prolonged smoking abstinence by ADHD subtype. RESULTS: The subtypes were similar in baseline demographic, smoking, and psychiatric history but differed in smoking cessation response to OROS-MPH or placebo as a function of nicotine dependence level. The 3-way interaction was significant; χ(2)(1) = 8.22, p < .01. Among highly dependent smokers, the prolonged abstinence rates were greater with OROS-MPH than with placebo in the ADHD-C group (60% vs. 31.3%, respectively, p < .05) but higher with placebo than with OROS-MPH in the ADHD-IN group (60% vs. 11.8%, respectively, p < .01). Abstinence rates did not differ by subtype or treatment among smokers who were less nicotine dependent. CONCLUSION: Contrasting treatment response and divergence in the impact of nicotine dependence level support the hypothesis of ADHD subtypes as distinct clinical entities and may indicate the need and directions for personalized targeted treatments of smokers with ADHD.

An exploration of site effects in a multisite trial of OROS-methylphenidate for smokers with attention deficit/hyperactivity disorder.

BACKGROUND: Multisite trials, the gold standard for conducting studies in community-based settings, can mask variability across sites resulting in misrepresentation of effects in specific sites. In a placebo-controlled trial of osmotic-release oral system methylphenidate (OROS-MPH) as augmentation treatment for smokers with attention deficit hyperactivity/impulsivity disorder (ADHD), three types of sites were selected according to their clinical research specialty (ADHD, smoking cessation, and general mental health). OBJECTIVE: Analysis was conducted to determine if clinical outcomes, that is, reduction in ADHD symptoms and smoking cessation rates, and the effect of treatment on these outcomes would differ by type of site. METHOD: A total of 255 adult smokers diagnosed with ADHD were enrolled in three clinic types: 72 in ADHD, 79 in tobacco dependence, and 104 in the mental health clinics. RESULTS: The three site-types were similar in demographic characteristics, smoking history, baseline level of ADHD symptoms, and history of psychiatric illness. Site-type but not a site-type by treatment interaction predicted prolonged smoking abstinence. A significant three-way interaction of site-type, treatment, and time-predicted improvement in ADHD symptoms. Moderate to strong effects of OROS-MPH relative to placebo were observed in the mental health and the ADHD clinics; a weak effect was observed in the tobacco dependence clinics. CONCLUSION: OROS-MPH benefit varied by site for reducing ADHD symptoms but not for improving smoking abstinence. SCIENTIFIC SIGNIFICANCE: Assessment of site-type effects can indicate the generalizability of findings from multisite trials and should be routinely incorporated in the design of multisite trials.

A comparison of abstinence outcomes among gay/bisexual and heterosexual male smokers in an intensive, non-tailored smoking cessation study.

INTRODUCTION: Smoking rates are higher among lesbian/gay/bisexual (LGB) than heterosexual (HT) individuals. However, there is scant information regarding smoking cessation treatments and outcomes in LGB populations. This study examined abstinence outcome in response to a high intensity smoking cessation program not specifically tailored to LGB smokers. METHODS: A total of 54 gay/bisexual (GB) and 243 HT male smokers received 8-week open treatment with nicotine patch, bupropion, and counseling. Participants reported biologically verified abstinence at multiple time points during the study. RESULTS: Demographic, smoking, and psychological characteristics at baseline were similar according to sexual orientation. During the first 2 weeks after quit day, abstinence rates were higher among GB smokers (Week 1: GB = 89%, HT = 82%; Week 2: GB = 77%, HT = 68%; ps < .05); abstinence rates converged subsequently, becoming nearly identical at the end of treatment (Week 8, GB = 59% vs. HT = 57%). In mixed effects longitudinal analysis of end-of-treatment outcome, sexual orientation (b = 1.40, SEM = 0.73, p = .056) and the Sexual Orientation x Time interaction (b = -0.146; SEM = 0.08, p = .058) approached statistical significance, reflecting the higher initial abstinence rates among GB smokers and the later convergence in abstinence rates by sexual orientation. DISCUSSION: This first report comparing smoking cessation treatment response by sexual orientation found higher initial and similar end-of-treatment abstinence rates in GB and HT smokers. Further work is needed to determine whether these observations from GB smokers who displayed a willingness to attend a non-tailored program and broad similarity with their HT counterparts in many baseline characteristics will replicate in other groups of GB smokers.

Smokers' response to combination bupropion, nicotine patch, and counseling treatment by race/ethnicity.

BACKGROUND: Evidence on how to tailor nicotine dependence treatment to specific race/ethnic groups is limited. The present study investigated responses to established smoking cessation treatments among African American, Hispanic, and White adults. METHODS: Participants were 559 smokers (126 African American, 73 Hispanic, and 360 White). All received treatment for eight weeks with open-label bupropion, the nicotine patch, and individual counseling. The dependent variable was tobacco abstinence during the last four weeks of treatment. The independent variables were race/ethnicity and other known predictors of abstinence, including sex, age, smoking history (nicotine dependence level, number of cigarettes smoked daily, serum cotinine level and expired carbon monoxide, number of past quit attempts, and age when daily smoking began), confidence in ability to stop smoking, body mass index, psychological status, and psychiatric history (past major depression and alcohol dependence). RESULTS: The total proportion of abstainers in the sample was 53%, with proportional differences by race/ethnicity (Whites 60%, African Americans 38%, Hispanics 41%). Compared to Whites, the odds ratios (OR) for quitting, adjusted for moderators of race/ ethnicity and other predictors of abstinence, were significantly lower among African Americans (OR .44, 95% confidence interval 195% CI] .27-.72) and Hispanics (OR .46, 95% CI .26-.81). CONCLUSION: Disparity in smoking cessation treatment outcome among African American and Hispanic smokers compared to Whites implies that the burden of tobacco-related illness will continue to fall disproportionately among minority racial/ethnic groups. Gaining knowledge on the effectiveness of nicotine dependence treatments and on the factors that facilitate or impede a successful response by minority smokers is a public health priority.

A randomized trial of bupropion and/or nicotine gum as maintenance treatment for preventing smoking relapse.

AIM: To investigate the efficacy of maintenance treatment with bupropion and/or nicotine gum for reducing smoking relapse. DESIGN, SETTING AND PARTICIPANTS: A 48-week study was conducted at a university-based smoking cessation clinic between February 2001 and October 2005. A total of 588 smokers received bupropion and nicotine patch in 8 weeks of open-label treatment (OLT); 289 abstainers during the last 4 weeks of OLT were randomized in double-blind placebo-controlled fashion to one of four arms for 16 weeks of maintenance treatment (MT) followed by 24 weeks of non-treatment follow-up (NTFU). INTERVENTION: Bupropion (300 mg/day) and 2 mg nicotine gum, used alone or combined, and comparable placebo pill and placebo gum. Behavioral counseling at all visits. OUTCOME: Time to relapse (TTR) from randomization. Relapse is defined as the first 7 consecutive days of smoking. Abstinence verified by carbon monoxide

Pre-cessation depressive mood predicts failure to quit smoking: the role of coping and personality traits.

AIMS: To examine whether mood, personality and coping predict smoking cessation and whether the associations of personality and coping are mediated through depressed mood. SETTING: Multicenter (n = 8) smoking cessation trial. PARTICIPANTS: A total of 600 smokers (> or = 15 cigarettes/day) without current depression who participated in a smoking cessation study. MEASUREMENTS: The outcome was continuous abstinence during the last 4 weeks of the 3-month trial: depressed mood was measured by the Beck Depression Inventory (BDI), personality by the Revised NEO Personality Inventory (NEO-PI-R) and coping by the Revised Ways of Coping Checklist (RWCC). FINDINGS: A total of 14.7% (88/600) were abstainers. Controlling for potential confounders, baseline BDI independently predicted smoking cessation. Smokers with BDI > or = 10 were less likely to quit than those with BDI < 10 (odds ratio: 6.39, 95% CI: 1.44-28.3, P = 0.01). Compared to BDI < 10 smokers, BDI > or = 10 smokers had significantly higher scores for neuroticism and lower scores for extraversion and conscientiousness (NEO-PI-R). On the RWCC, BDI > or = 10 smokers scored higher for blame self, wishful thinking and problem avoidance and they scored lower on problem focus than smokers with BDI < 10. A mediational analysis showed that neither personality traits nor coping skills predicted directly smoking cessation. However, low level of problem focusing and social support seeking predicted a negative outcome via depressed mood. CONCLUSION: A BDI score > or = 10, even in smokers who do not meet a current diagnosis of major depression, directly predicts inability to quit. This suggests the utility of assessing depression symptoms in routine smoking cessation care.

Tobacco use and suicide attempt: longitudinal analysis with retrospective reports.

BACKGROUND: Suicide has been associated with smoking/tobacco use but its association of and change in smoking/tobacco use status with suicide attempt (SA) is not well established. METHODS: We investigated whether persistent, former tobacco use, initiation, quitting tobacco use, relapse to tobacco use, and DSM-IV nicotine dependence predict independently SA using Wave 1 and 2 data of the National Epidemiologic Survey of Alcohol and Related Conditions. Data from 34,653 US adults interviewed at Wave 1 (2001-02) and Wave 2 (2004-05) were analyzed. The main outcome measure was SA between Wave 1 and Wave 2 as reported at Wave 2. RESULTS: Among the 1,673 respondents reporting lifetime SA at Wave 2, 328 individuals reported SA between Wave 1 and Wave 2. Current and former tobacco use at Wave 1 predicted Wave 2 SA independently of socio-demographic characteristics, psychiatric history, and prior SA (Adjusted Odds Ratio (AOR): 1.49; 95% CI: 1.13-1.95, AOR: 1.31; 95% CI:1.01-1.69, respectively versus never tobacco users). The strongest association with SA was observed among former tobacco users who relapsed after Wave 1 (AOR: 4.66; 95% CI: 3.49-6.24) and among tobacco use initiators after Wave 1 (AOR: 3.16; 95% CI: 2.23-4.49). Persistent tobacco use (current tobacco use at both Wave 1 and Wave 2) also had an increased risk of SA (AOR: 1.89; 95% CI: 1.47-2.42). However, former tobacco users in both Waves 1 and 2 did not show a significantly elevated risk for SA in Wave 2 (AOR:1.09, 95% CI: 0.78-1.52) suggesting that the risk resided mainly in Wave 1 former tobacco users who relapsed to tobacco use by Wave 2. DSM-IV nicotine dependence did not predict SA at Wave 2. CONCLUSION: In a representative sample of US adults, relapse, tobacco use initiation, and persistent tobacco use, which are amenable to intervention, were associated with risk of SA.

Anxiety and Depressed Mood Decline Following Smoking Abstinence in Adult Smokers with Attention Deficit Hyperactivity Disorder.

INTRODUCTION: A preponderance of relevant research has indicated reduction in anxiety and depressive symptoms following smoking abstinence. This secondary analysis investigated whether the phenomenon extends to smokers with attention deficit hyperactivity disorder (ADHD). METHODS: The study setting was an 11-Week double-blind placebo-controlled randomized trial of osmotic release oral system methylphenidate (OROS-MPH) as a cessation aid when added to nicotine patch and counseling. Participants were 255 adult smokers with ADHD. The study outcomes are: anxiety (Beck Anxiety Inventory (BAI)) and depressed mood (Beck Depression Inventory II (BDI)) measured one Week and six Weeks after a target quit day (TQD). The main predictor is point-prevalence abstinence measured at Weeks 1 and 6 after TQD. Covariates are treatment (OROS-MPH vs placebo), past major depression, past anxiety disorder, number of cigarettes smoked daily, demographics (age, gender, education, marital status) and baseline scores on the BAI, BDI, and the DSM-IV ADHD Rating Scale. RESULTS: Abstinence was significantly associated with lower anxiety ratings throughout the post-quit period (p<0.001). Depressed mood was lower for abstainers than non-abstainers at Week 1 (p<0.05), but no longer at Week 6 (p=0.83). Treatment with OROS-MPH relative to placebo showed significant reductions at Week 6 after TQD for both anxiety (p<0.05) and depressed mood (p<0.001), but not at Week 1. Differential abstinence effects of gender were observed. Anxiety and depression ratings at baseline predicted increased ratings of corresponding measures during the post-quit period. CONCLUSION: Stopping smoking yielded reductions in anxiety and depressed mood in smokers with ADHD treated with nicotine patch and counseling. Treatment with OROS-MPH yielded mood reductions in delayed manner.

Cigarette Smoking During Substance Use Disorder Treatment: Secondary Outcomes from a National Drug Abuse Treatment Clinical Trials Network study.

INTRODUCTION: The majority of patients enrolled in treatment for substance use disorders (SUDs) also use tobacco. Many will continue to use tobacco even during abstinence from other drugs and alcohol, often leading to smoking-related illnesses. Despite this, little research has been conducted to assess the influence of being a smoker on SUD treatment outcomes and changes in smoking during a treatment episode. METHODS: In this secondary analysis, cigarette smoking was evaluated in participants completing outpatient SUD treatment as part of a multi-site study conducted by the National Drug Abuse Treatment Clinical Trials Network. Analyses included the assessment of changes in smoking and nicotine dependence via the Fagerström Test for Nicotine Dependence during the 12-week study among all smokers (aim #1), specifically among those in the experimental treatment group (aim #2), and the moderating effect of being a smoker on treatment outcomes (aim #3). RESULTS: Participants generally did not reduce or quit smoking throughout the course of the study. Among a sub-set of participants with higher baseline nicotine dependence scores randomized to the control arm, scores at the end of treatment were lower compared to the experimental arm, though measures of smoking quantity did not appear to decrease. Further, being a smoker was associated with poorer treatment outcomes compared to non-smokers enrolled in the trial. CONCLUSIONS: This study provides evidence that patients enrolled in community-based SUD treatment continue to smoke, even when abstaining from drugs and alcohol. These results add to the growing literature encouraging the implementation of targeted, evidence-based interventions to promote abstinence from tobacco among SUD treatment patients.

A randomized trial of sertraline as a cessation aid for smokers with a history of major depression.

OBJECTIVE: Evidence that major depression can be a significant hindrance to smoking cessation prompted this examination of the usefulness of sertraline as a cessation aid for smokers with a history of major depression. Specifically, sertraline's efficacy for smoking abstinence and its effects on withdrawal symptoms were evaluated. METHOD: The study design included a 1-week placebo washout, a 9-week double-blind, placebo-controlled treatment phase followed by a 9-day taper period, and a 6-month drug-free follow-up. One hundred thirty-four smokers with a history of major depression were randomly assigned to receive sertraline (N=68) or matching placebo (N=66); all received intensive individual cessation counseling during nine clinic visits. RESULTS: Sertraline treatment produced a lower total withdrawal symptom score and less irritability, anxiety, craving, and restlessness than placebo. However, the abstinence rates did not significantly differ between treatment groups: 28.8% (19 of 66) for placebo and 33.8% (23 of 68) for sertraline at the end of treatment and 16.7% (11 of 66) for placebo and 11.8% (eight of 68) for sertraline at the 6-month follow-up. No moderating effects of single or recurrent major depression, depressed mood at baseline, nicotine dependence level, or gender were observed. CONCLUSIONS: Sertraline did not add to the efficacy of an intensive individual counseling program in a double-blind, placebo-controlled study. However, given that the end-of-treatment abstinence rate for the placebo group was much higher than expected, it is unclear whether a ceiling effect of the high level of psychological intervention received by all subjects prevented an adequate test of sertraline.

Nicotine dependence: the role for antidepressants and anxiolytics.

The addictive nature of cigarette smoking has been appreciated only in the past two decades. Prior to the publication of DSM-III in 1980, excessive tobacco use had not been considered as a psychiatric problem requiring treatment [1]. Smoking has been recognized as a serious medical problem since thefirst Surgeon General's Report on Smoking and Health in 1964. An important development during the 10 to 20 years following this report was the growth of knowledge regarding the physiological effects of regular tobacco use and the importance of nicotine as the main pharmacological ingredient in tobacco. This body of information culminated in the 1988 Surgeon General's Report, which recognized chronic tobacco use as a form of addictive behavior [2]. Nicotine, like other drugs of abuse, has reinforcing psychoactive effects that lead to its repeated self-administration. Nicotine stimulates the release of several neurotransmitters including dopamine, norepinephrine, acetylcholine, 5-hydroxytryptamine, gamma-aminobutyric acid (GABA) and endorphins [3]. Through its effects on the dopaminergic, or 'reward', system, nicotine exerts psychoactive effects such as an increased sense of enjoyment. The norepinephrinergic effects of nicotine may account for increased attentiveness and improved performance in repetitive tasks, while its anxiolytic effects are likely mediated through GABA and the endorphins.

Treating nicotine dependence by targeting attention-deficit/ hyperactivity disorder (ADHD) with OROS methylphenidate: the role of baseline ADHD severity and treatment response.

OBJECTIVE: To determine whether treatment of attention-deficit/hyperactivity disorder (ADHD) with osmotic-release oral system (OROS) methylphenidate promotes abstinence from smoking among smokers with ADHD who have greater severity of ADHD symptoms at baseline or greater improvement in ADHD during treatment. METHOD: This is a secondary analysis of data from a randomized, double-blind, 11-week trial conducted between December 2005 and January 2008 at 6 clinical sites; the original trial was sponsored by the National Drug Abuse Clinical Trials Network. Adult cigarette smokers (aged 18-55 years) who met DSM-IV criteria for ADHD were randomly assigned to OROS methylphenidate (72 mg/d) (n = 127) or matching placebo (n = 128). All participants received nicotine patches (21 mg/d) and weekly individual smoking cessation counseling. Logistic regression was used to model prolonged abstinence from smoking (ascertained by self-report and breath carbon monoxide testing) as a function of treatment, baseline ADHD Rating Scale-IV (ADHD-RS) score, change in ADHD-RS score during treatment, and their interactions. RESULTS: Treatment interacted with both ADHD-RS score at baseline (P = .01) and change in ADHD-RS score during treatment (P = .008). Among patients with higher ADHD-RS scores (> 36) at baseline and the most improvement in ADHD during treatment (ADHD-RS change score ≥ 24), 70.0% of those who took OROS methylphenidate achieved abstinence from smoking compared to 36.8% of those who took placebo (P = .02). In contrast, among patients with the lowest ADHD-RS baseline scores (≤ 30), 30.3% of those who took OROS methylphenidate achieved abstinence from smoking compared to 60.7% of those who took placebo (P = .02). CONCLUSIONS: OROS methylphenidate, in combination with nicotine patch, may be an effective treatment for nicotine dependence among smokers with more severe ADHD and more robust response of ADHD symptoms to medication. OROS methylphenidate may be counterproductive among smokers with lower severity of ADHD. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00253747.

Attention-deficit/hyperactivity disorder (ADHD) symptoms, craving to smoke, and tobacco withdrawal symptoms in adult smokers with ADHD.

BACKGROUND: Tobacco withdrawal symptoms may be confounded with attention-deficit/hyperactivity disorder (ADHD) symptoms among smokers with ADHD. OBJECTIVE: (1) To assess overlap between ADHD symptoms and tobacco/nicotine withdrawal symptoms and craving; (2) to assess the relationship between craving or withdrawal symptoms and the effect of osmotic-release oral system methylphenidate (OROS-MPH) on ADHD symptoms; (3) to assess the association of ADHD symptoms, craving, and withdrawal symptoms with abstinence. METHODS: Secondary analysis of a randomized, placebo controlled smoking cessation trial assessing the efficacy of OROS-MPH taken in addition to nicotine patch among individuals with ADHD. ADHD symptoms, withdrawal symptoms, and craving were assessed at baseline and 2, 4 and 6 weeks after a target quit day. RESULTS: Withdrawal symptoms and craving showed limited and modest overlap with ADHD symptoms prior to abstinence but more extensive and stronger correlation after quit day. Compared to placebo, OROS-MPH reduced ADHD symptoms; this effect was attenuated by controlling for withdrawal symptoms, but not by craving. Craving, but not ADHD symptoms and withdrawal symptoms, was associated with abstinence during the trial. CONCLUSION: When treating smokers with ADHD (1) craving, rather than tobacco withdrawal symptoms or ADHD symptoms may be the more effective therapeutic smoking cessation targets; (2) careful distinction of craving, withdrawal symptoms, and ADHD symptoms when assessing withdrawal phenomena is needed.

Smoking and suicidal behaviours in a sample of US adults with low mood: a retrospective analysis of longitudinal data.

OBJECTIVE: To investigate whether: (1) smoking predicts suicide-related outcomes (SROs), (2) prior SRO predicts smoking, (3) smoking abstinence affects the risk of SRO and (4) psychiatric comorbidity modifies the relationship between smoking and SRO. DESIGN: Retrospective analysis of longitudinal data obtained in wave 1 (2001-2002) and wave 2 (2004-2005) of the National Epidemiologic Survey on Alcohol and Related Conditions. SETTING: Face-to-face interviews conducted with persons in the community. PARTICIPANTS: US adults (N=43 093) aged 18 years or older were interviewed in wave 1 and reinterviewed (N=34 653) 3 years later. For the present study, the sample was the subset of persons (N=7352) who at the wave 2 interview reported low mood lasting 2 weeks or more during the past 3 years and were further queried regarding SRO occurring between waves 1 and 2. OUTCOME MEASURES: SRO composed of any of the following: (1) want to die, (2) suicidal ideation, (3) suicide attempt, reported at wave 2. Current smoking reported at wave 2. RESULTS: Current and former smoking in wave 1 predicted increased risk for wave 2 SRO independently of prior SRO, psychiatric history and socio-demographic characteristics measured in wave 1 (adjusted OR (AOR)=1.41, 95% CI 1.28 to 1.55 for current smoking; AOR=1.32, 95% CI 1.21 to 1.43 for former smoking). Prior SRO did not predict current smoking in wave 2. Compared with persistent never-smokers, risk for future SRO was highest among relapsers (AOR=3.42, 95% CI 2.85 to 4.11), next highest among smoking beginners at wave 2 (AOR=1.82, 95% CI 1.51 to 2.19) and lowest among long-term (4+ years) former smokers (AOR=1.22, 95% CI 1.12 to 1.34). Compared with persistent current smokers, risk for SRO was lower among long-term abstainers (p<0.0001) but not among shorter-term abstainers (p=0.26). CONCLUSIONS: Smoking increased the risk of future SRO independently of psychiatric comorbidity. Abstinence of several years duration reduced that risk.

Depressive mood, suicide ideation and anxiety in smokers who do and smokers who do not manage to stop smoking after a target quit day.

AIMS: The effect of successful and unsuccessful smoking cessation on depressive mood, anxiety- and suicide-related outcomes is unclear. The aim of this secondary analysis was to explore the relationship between abstinence status and these outcomes. DESIGN: Cohort of adult smokers attempting to stop smoking. Smoking status was assessed by a daily diary; depressed mood, anxiety and suicidal tendencies by the Hamilton Depression Rating Scale (HDRS). The association of complete and point-prevalence abstinence with the HDRS variables was assessed using multi-level linear regression models. SETTING: Randomized trial of sertraline versus placebo for smoking cessation with weekly behavioural support provided in a clinic. PARTICIPANTS: A total of 133 adult smokers with past major depression. FINDINGS: Pre-quit mood scores did not predict smoking status post-quit day. Both continuous and point-prevalence abstainers had significantly lower total HDRS, suicide and anxiety scores, adjusted for all potential confounders, during the period following quit day than did non-abstainers who experienced a significant mood deterioration. There was a significant effect of sertraline on post-quit HDRS scores but not on abstinence. CONCLUSIONS: Contrary to expectation, smoking abstinence among smokers with a history of major depression did not lead to increase in depression, anxiety or suicide ideation; however, failed quit attempts did. Persisting with a quit attempt while unable to achieve abstinence may be associated with mood deterioration.

OROS-methylphenidate or placebo for adult smokers with attention deficit hyperactivity disorder: racial/ethnic differences.

OBJECTIVE: To explore racial/ethnic difference in OROS-methylphenidate (OMPH) efficacy when added to nicotine patch and counseling for treating nicotine dependence among smokers with attention deficit hyperactivity disorder (ADHD). METHOD: Participants were adult smokers with ADHD (202 whites and 51 non-whites) randomly assigned to OMPH or placebo in a multi-site, randomized controlled trial. Study outcomes were complete, prolonged, and point-prevalence abstinence at the end of treatment, and weekly ratings of ADHD symptoms, tobacco withdrawal symptoms, and desire to smoke. RESULTS: The rate of four-week complete abstinence (no slips or lapses) was significantly higher with OMPH than placebo among non-white (OMPH=42.9%, placebo=13.3%, chi(2)(1)=5.20, p=0.02) but not white participants (OMPH=23.1%, placebo=23.5%, chi(2)(1)=0.00, p=0.95). Patterns of prolonged and point-prevalence abstinence among non-whites were similar but fell short of statistical significance. OMPH reduced ADHD symptoms in both race/ethnic groups, and produced greater reductions in desire to smoke and withdrawal symptoms among the non-white than white participants. Change in desire to smoke, but not in withdrawal or ADHD symptoms predicted abstinence. The ability of OMPH to reduce desire to smoke among non-whites appeared to mediate the medication's positive effect on abstinence. CONCLUSION: Differential efficacy favoring non-whites of a medication for achieving smoking cessation is a potentially important finding that warrants further investigation. OROS-MPH could be an effective treatment for nicotine dependence among a subgroup of smokers.

Impact of attention-deficit/hyperactivity disorder (ADHD) treatment on smoking cessation intervention in ADHD smokers: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: High smoking rates in adults with attention-deficit/hyperactivity disorder (ADHD) and nicotine's amelioration of ADHD suggest that effective ADHD treatment might facilitate abstinence in smokers with ADHD. The present study evaluated if using osmotic-release oral system methylphenidate (OROS-MPH) to treat ADHD enhances response to smoking cessation treatment in smokers with ADHD. METHOD: A randomized, double-blind, placebo-controlled, 11-week trial with a 1-month follow-up was conducted at 6 clinical sites between December 2005 and January 2008. Adults (aged 18-55 years) meeting DSM-IV criteria for ADHD and interested in quitting smoking were randomly assigned to OROS-MPH titrated to 72 mg/d (n = 127) or placebo (n = 128). All participants received brief weekly individual smoking cessation counseling for 11 weeks and 21 mg/d nicotine patches starting on the smoking quit day (day 27) through study week 11. Outcome measures included prolonged smoking abstinence and DSM-IV ADHD Rating Scale (ADHD-RS) score. RESULTS: Of 255 randomly assigned participants, 204 (80%) completed the trial. Prolonged abstinence rates, 43.3% and 42.2%, for the OROS-MPH and placebo groups, respectively, did not differ significantly (OR = 1.1; 95% CI, 0.63-1.79; P = .81). Relative to placebo, OROS-MPH evidenced a greater reduction in DSM-IV ADHD-RS score (P < .0001) and in cigarettes per day during the post-quit phase (P = .016). Relative to placebo, OROS-MPH increased blood pressure and heart rate to a statistically, but not clinically, significant degree (P < .05); medication discontinuation did not differ significantly between treatments. CONCLUSIONS: Treatment for ADHD did not improve smoking cessation success; OROS-MPH, relative to placebo, effectively treated ADHD and was safe and generally well tolerated in this healthy sample of adult ADHD smokers. TRIAL REGISTRATION: clinical trials.gov Identifier: NCT00253747.