Tobacco use behaviors and views on engaging in clinical trials for tobacco cessation among individuals who experience homelessness.

Background: Clinical trials that include contingency management for smoking cessation have shown promising results for short-term quitting, but none have explored this approach for long-term abstinence in people experiencing homelessness. We designed a clinical trial of an extended contingency management intervention for smoking cessation for people experiencing homelessness. This study has two aims: (1) to explore tobacco use behaviors, and views toward smoking cessation, and (2) to explore factors influencing acceptability of engaging in such a trial in a sample of adult smokers experiencing homelessness. Methods: We administered a questionnaire to obtain information on tobacco use behaviors and conducted in-depth, semi-structured interviews with 26 patients who had experienced homelessness and were patients at a safety net health clinic in San Francisco, California, where we planned to pilot the intervention. We obtained information on triggers for tobacco use, prior cessation experiences, attitudes toward cessation, attitudes toward engaging in a clinical trial for cessation, and factors that might influence participation in our proposed contingency management clinical trial. We analyzed transcripts using content analysis. Results: Participants described the normative experiences of smoking, co-occurring substance use, and the use of tobacco to relieve stress as barriers to quitting. Despite these barriers, most participants had attempted to quit smoking and most were interested in engaging in a clinical trial as a method to quit smoking. Participants noted that desirable features of the trial include: receiving financial incentives to quit smoking, having a flexible visit schedule, having the study site be easily accessible, and having navigators with lived experiences of homelessness. Conclusion: A patient-centric clinical trial design that includes incentives, flexible visits and navigators from the community may increase feasibility of engaging in clinical trials among individuals experiencing homelessness.

Contingency management to promote smoking cessation in people experiencing homelessness: Leveraging the electronic health record in a pilot, pragmatic randomized controlled trial.

BACKGROUND: Cigarette smoking is disproportionately high among people experiencing homelessness (PEH). Contingency management (CM) is a strategy that has shown considerable efficacy for smoking cessation and has been used in short-term studies of smoking abstinence in PEH. We describe a pilot, pragmatic randomized controlled trial protocol, which leverages an electronic health record (EHR) infrastructure to assess the feasibility and acceptability of an extended CM intervention to improve long-term abstinence in PEH. METHODS: We will conduct the study at three safety-net clinics in San Francisco among 90 adults experiencing homelessness who smoke cigarettes currently and have a desire to quit. We will encourage all participants to receive smoking cessation services that include behavioral counseling and pharmacotherapy through their clinics. We will randomly assign participants to an extended CM intervention group with escalating incentives contingent on abstinence or to a control group with fixed incentives for attending study visits. We will use the EHR to recruit participants, track receipt of counseling and pharmacotherapy during clinical care, and communicate with providers on participants' progress. CM participants will get escalating incentives for demonstration of carbon monoxide-verified abstinence over 6 months, with a total possible earnings of $475. Control participants will receive a fixed incentive of $5 for attending study visits, totaling $125. We will conduct the carbon-monoxide verified abstinence assessments-which will determine CM incentive amounts-daily during week 1, bi-weekly through week 4, weekly through week 13, and monthly through week 24. Measures of feasibility and acceptability, both quantitative and qualitative, will include assessments of screening and recruitment, adherence to study visits, engagement in smoking cessation clinical care, retention, and participant satisfaction. One of the primary clinical outcomes will be biochemically verified 7-day point prevalence abstinence at 6 months. We will measure secondary outcomes, which will include 7-day point prevalence abstinence at 2 weeks, 3 and 12 months. DISCUSSION: This trial will allow us to assess the feasibility and acceptability of a CM cessation intervention among PEH. The protocol's clinical setting and use of EHRs gives it significant potential for scalability. If found to be feasible, acceptable, and subsequently efficacious in a larger trial, the intervention could reduce tobacco-related health disparities by increasing long-term smoking abstinence among this vulnerable population. TRIAL REGISTRATION: ClinicalTrials.gov NCT04982952. Registered on July 29, 2021.

Cigarette Smoking, Mental Health, and Other Substance Use among Court-Involved Youth.

Background: Justice-involved youth are at risk to become cigarette smokers as they age, leading to a variety of poor health outcomes. However, little is known about cigarette use among justice-involved youth, especially youth supervised in the community where there is ample opportunity to smoke. Objective: This study investigates the prevalence of cigarette smoking and the associations between cigarette smoking, emotional and behavioral functioning, and other substance use among a sample of first-time offending court-involved, non-incarcerated (FTO-CINI) youth. Methods: Youth were recruited from a family court in the Northeast (N = 423). Substance use was self-reported using the Adolescent Risk Behavior Assessment (ARBA). Emotional and behavioral functioning was measured using the Behavior Assessment Schedule for Children-Second Edition (BASC-2), the Affect Dysregulation Scale (ADS), National Stressful Events Survey PTSD Short Scale (NSESSS), and the National Survey of Self-Reported Delinquency (NYS-SRD). Results: About 9.9% of FTO-CINI youth had smoked cigarettes in the past 30 days. Compared with FTO-CINI youth who had not smoked recently, recent smokers endorsed more emotional and behavioral symptoms, such as school problems (p < .001), internalizing problems (p = .012), inattention/hyperactivity (p = .020), affect dysregulation (p = .044), PTSD symptoms (p = .006), and delinquent behavior (p < .001). Recent smokers were also more likely to use alcohol (OR = 5.61, p < .001), marijuana (OR = 11.27, p < .001), and other drugs (OR = 5.00, p < .001). Conclusions: Recent smoking was higher among FTO-CINI youth than youth in the general population. Findings underscore the need to incorporate nicotine into existing substance use prevention interventions for this population, who are at high risk to initiate cigarette use as they age.

Cigarette Smoking Cessation Intervention for Buprenorphine Treatment Patients.

Introduction: Patients receiving medication assisted therapy (MAT) for opioid use disorder have high cigarette smoking rates. Cigarette smoking interventions have had limited success. We evaluated an intervention to increase cigarette abstinence rates in patients receiving buprenorphine-assisted therapy. Methods: Cigarette smokers (N = 175; 78% male; 69% Caucasian; 20% Hispanic), recruited from a buprenorphine clinic were randomly assigned to either an extended innovative system intervention (E-ISI) or to Standard Treatment Control (STC). The E-ISI combined motivational intervention with extended treatment (long-term nicotine replacement therapy , varenicline, and extended cognitive behavioral therapy). STC received written information about quit-lines, medication, and resources. Assessments were held at baseline and 3, 6, 12, and 18 months. Seven-day biochemically verified point-prevalence cigarette abstinence was the primary outcome measure. Results: Fifty-four percent of E-ISI participants entered the extended treatment intervention; E-ISI and STC differed at 3 months on abstinence status but not at months 6, 12, and 18. E-ISI participants were more likely to attempt to quit, to have a goal of complete abstinence, and to be in a more advanced stage of change than STC participants. A higher number of cigarettes smoked and the use of cannabis in the previous 30 days predicted continued smoking. Conclusions: The E-ISI was successful in increasing motivation to quit smoking but did not result in long-term abstinence. The failure of treatments that have been efficacious in the general population to produce abstinence in patients receiving MAT of opioid use disorder suggests that harm reduction and other innovative interventions should be explored. Implications: This study demonstrates that an intervention combining motivational interviewing with an extended treatment protocol can increase cigarette quit attempts, enhance cigarette abstinence goals, and further movement through stages of change about quitting smoking in patients receiving MAT for opioid use disorder who smoke cigarettes. The intervention did not increase abstinence rates over those observed in a standard treatment control, however. The latter finding supports those of earlier investigators who also failed to find efficacy for smoking cessation in this population and who also used interventions effective in the general population. This pattern of findings suggests that patients with opioid use disorder can be motivated to change smoking behavior, but alternative and innovative approaches to cigarette smoking treatment should be studied.

Nicotine biomarkers and rate of nicotine metabolism among cigarette smokers taking buprenorphine for opioid dependency.

BACKGROUND: Individual differences in the rate of nicotine metabolism contribute to differences in tobacco use, dependence, and efficacy of smoking cessation treatments and can be assessed using the nicotine metabolite ratio (NMR), a validated biomarker for CYP2A6 activity. Despite the high cigarette smoking rates observed in opioid users, no data have been reported on NMR among this population as they has been largely excluded from previous studies that have examined the relationship between tobacco use characteristics and rate of nicotine metabolism. METHODS: A linear regression model was used to examine the relationship between tobacco use characteristics and NMR among smokers taking buprenorphine for opioid dependency (N=141). The relationship between buprenorphine dose and NMR was also examined. All participants were enrolled in an intervention designed to promote cigarette-smoking cessation, though participants did not need to stop smoking to enroll. RESULTS AND CONCLUSIONS: Rate of nicotine metabolism assessed using the NMR was positively associated with cigarettes smoked in the past 24h, but was not related to time to first cigarette or past year quit attempts. Dose of buprenorphine was not associated with NMR, suggesting no association with rate of nicotine metabolism. Our results suggest that NMR is related to tobacco use among persons enrolled in opioid treatment, as reported in general population smokers and may be a useful biomarker to include in future research assessing efficacy of tobacco cessation interventions in this population.

Retrospective analysis of changing characteristics of treatment-seeking smokers: implications for further reducing smoking prevalence.

OBJECTIVE: The goal of the current study was to empirically compare successive cohorts of treatment-seeking smokers who enrolled in randomised clinical trials in a region of the USA characterised by strong tobacco control policies and low smoking prevalence, over the past three decades. DESIGN: Retrospective treatment cohort comparison. SETTING: Data were collected from 9 randomised clinical trials conducted at Stanford University and the University of California, San Francisco, between 1990 and 2013. PARTICIPANTS: Data from a total of 2083 participants were included (Stanford, n=1356; University of California San Francisco, n=727). PRIMARY AND SECONDARY OUTCOMES: One-way analysis of variance and covariance, χ(2) and logistic regression analyses were used to examine relations between nicotine dependence, cigarettes per day, depressive symptoms and demographic characteristics among study cohorts. RESULTS: Similar trends were observed at both settings. When compared to earlier trials, participants in more recent trials smoked fewer cigarettes, were less nicotine-dependent, reported more depressive symptoms, were more likely to be male and more likely to be from a minority ethnic/racial group, than those enrolled in initial trials (all p's<0.05). Analysis of covariances revealed that cigarettes per day, nicotine dependence and current depressive symptom scores were each significantly related to trial (all p's<0.001). CONCLUSIONS: Our findings suggest that more recent smoking cessation treatment-seeking cohorts in a low prevalence region were characterised by less smoking severity, more severe symptoms of depression and were more likely to be male and from a minority racial/ethnic group.

Withdrawal exposure with withdrawal regulation training for smoking cessation: a randomized controlled pilot trial.

INTRODUCTION: Although withdrawal processes form a key motivational basis for cigarette use, smoking cessation treatments appear to exert only modest effects on withdrawal. One treatment option for further reducing withdrawal severity would be to provide smokers with withdrawal regulation training. The objective of this study was to pilot a smoking cessation intervention comprising withdrawal exposure with withdrawal regulation training. METHODS: Adult smokers (N=80) were randomized to one of two conditions: 1) Withdrawal Exposure with Withdrawal Regulation Training (WT), which included the development and application of individualized withdrawal regulation strategies over four separate sessions that spanned the first four hours of abstinence; 2) or Relaxation Control (RC) training, which controlled for the therapeutic contact of WT. All sessions occurred before the quit date, after which differential treatment was discontinued and all participants received brief counseling, nicotine replacement therapy, and self-help literature. Biochemically-confirmed (CO≤3) seven-day point-prevalence abstinence was assessed at Months 2 and 3 after end-of-treatment. RESULTS: Treatment completion and ratings of credibility and efficacy were high and equivalent across conditions. 22.2% of participants in the WT condition were abstinent at both time points, whereas 0% and 4.2% of participants in the RC condition were abstinent at Months 2 and 3 (Month 3 OR=6.5 [0.73, 59.19]). In-session withdrawal ratings suggested WT improved regulation of withdrawal symptoms, which were in turn associated with abstinence. CONCLUSIONS: This small pilot study suggests that WT promotes abstinence by enhancing withdrawal regulation. Results warrant further investigation of this innovative treatment approach.

Smokers with serious mental illness and requests for nicotine replacement therapy post-hospitalisation.

BACKGROUND AND AIMS: Smoke-free psychiatric hospitalisation provides opportunity for initiating tobacco cessation treatment. The current study reports on psychiatric patients' interest in continuing nicotine replacement therapy (NRT) posthospitalisation and examines patient predictors of NRT requests, quit attempts and abstinence at 1-week follow-up. METHODS: Daily smokers were recruited and interviewed on locked psychiatric units at three smoke-free San Francisco Bay Area hospitals. Intent to quit smoking was not required to participate and 73% of eligible smokers enrolled. Analyses focused on 816 participants (49% female) randomised to interventions providing counselling tailored to readiness to quit with availability of NRT posthospitalisation. Logistic regressions tested demographic, smoking and psychiatric factors predictive of NRT requests, quit attempts and abstinence 1-week postdischarge. RESULTS: Participants averaged 17 (SD=10) cigarettes/day for an average of 19 (SD=14) years. Most (88%) requested study-provided NRT (74% right at discharge). Participants preparing to quit and those with more severe psychiatric symptoms were more likely to request NRT at discharge (p<0.01). Those with more severe psychiatric symptoms also were more likely to request NRT refill, as were older participants (p<0.05). Participants who requested NRT at discharge were more likely to make a 24 h quit attempt and self-report abstinence at the 1-week follow-up (54% quit attempt, 14% abstinent) than participants who did not (25% quit attempt, 4% abstinent) (p<0.05). CONCLUSIONS: The great demand for NRT and the association between NRT use with quit attempts and abstinence at 1-week posthospitalisation supports adoption of tobacco treatment in acute psychiatric settings. TRIAL REGISTRATION NUMBER: # NCT00968513.

Cost-effectiveness of smoking cessation treatment initiated during psychiatric hospitalization: analysis from a randomized, controlled trial.

OBJECTIVE: We examined the cost-effectiveness of smoking cessation treatment for psychiatric inpatients. METHOD: Smokers, regardless of intention to quit, were recruited during psychiatric hospitalization and randomized to receive stage-based smoking cessation services or usual aftercare. Smoking cessation services, quality of life, and biochemically verified abstinence from cigarettes were assessed during 18 months of follow-up. A Markov model of cost-effectiveness over a lifetime horizon was constructed using trial findings and parameters obtained in a review of the literature on quit and relapse rates and the effect of smoking on health care cost, quality of life, and mortality. RESULTS: Among 223 smokers randomized between 2006 and 2008, the mean cost of smoking cessation services was $189 in the experimental treatment group and $37 in the usual care condition (P < .001). At the end of follow-up, 18.75% of the experimental group was abstinent from cigarettes, compared to 6.80% abstinence in the usual care group (P < .05). The model projected that the intervention added $43 in lifetime cost and generated 0.101 additional quality-adjusted life-years (QALYs), an incremental cost-effectiveness ratio of $428 per QALY. Probabilistic sensitivity analysis found the experimental intervention was cost-effective against the acceptance criteria of $50,000/QALY in 99.0% of the replicates. CONCLUSIONS: A cessation intervention for smokers identified in psychiatric hospitalization did not result in higher mental health care costs in the short-run and was highly cost-effective over the long-term. The stage-based intervention was a feasible and cost-effective way of addressing the high smoking prevalence in persons with serious mental illness. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00136812.

The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults.

BACKGROUND: Tobacco use remains the leading cause of premature morbidity and mortality in the United States. Young adults are less successful at quitting, use cessation treatment less often than smokers of other ages, and can be a challenge to retain in treatment. Social media, integrated into the lives of many young adults, represents a promising strategy to deliver evidence-based smoking cessation treatment to a large, diverse audience. The goal of this trial is to test the efficacy of a stage-based smoking cessation intervention on Facebook for young adults age 18 to 25 on smoking abstinence, reduction in cigarettes smoked, and thoughts about smoking abstinence. METHODS/DESIGN: This is a randomized controlled trial. Young adult smokers throughout the United States are recruited online and randomized to either the 3 month Tobacco Status Project intervention on Facebook or a referral to a smoking cessation website. The intervention consists of assignment to a secret Facebook group tailored to readiness to quit smoking (precontemplation, contemplation, preparation), daily Facebook contacts tailored to readiness to quit smoking, weekly live counseling sessions, and for those in preparation, weekly Cognitive Behavioral Therapy counseling sessions on Facebook. Primary outcome measure is biochemically-verified 7-day point prevalence abstinence from smoking at posttreatment (3 months), 6, and 12 months. Secondary outcome measures are reduction of 50 % or more in cigarettes smoked, 24 h quit attempts, and commitment to abstinence at each time point. A secondary aim is to test, within the TSP condition, the effect of a monetary incentive at increasing engagement in the intervention. DISCUSSION: This randomized controlled trial is testing a novel Facebook intervention for treating young adults' tobacco use. If efficacious, the social media intervention could be disseminated widely and expanded to address additional health risks. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02207036 , May 13, 2014.

Drug Metabolizing Enzyme and Transporter Gene Variation, Nicotine Metabolism, Prospective Abstinence, and Cigarette Consumption.

The Nicotine Metabolite Ratio (NMR, ratio of trans-3'-hydroxycotinine and cotinine), has previously been associated with CYP2A6 activity, response to smoking cessation treatments, and cigarette consumption. We searched for drug metabolizing enzyme and transporter (DMET) gene variation associated with the NMR and prospective abstinence in 2,946 participants of laboratory studies of nicotine metabolism and of clinical trials of smoking cessation therapies. Stage I was a meta-analysis of the association of 507 common single nucleotide polymorphisms (SNPs) at 173 DMET genes with the NMR in 449 participants of two laboratory studies. Nominally significant associations were identified in ten genes after adjustment for intragenic SNPs; CYP2A6 and two CYP2A6 SNPs attained experiment-wide significance adjusted for correlated SNPs (CYP2A6 PACT=4.1E-7, rs4803381 PACT=4.5E-5, rs1137115, PACT=1.2E-3). Stage II was mega-regression analyses of 10 DMET SNPs with pretreatment NMR and prospective abstinence in up to 2,497 participants from eight trials. rs4803381 and rs1137115 SNPs were associated with pretreatment NMR at genome-wide significance. In post-hoc analyses of CYP2A6 SNPs, we observed nominally significant association with: abstinence in one pharmacotherapy arm; cigarette consumption among all trial participants; and lung cancer in four case:control studies. CYP2A6 minor alleles were associated with reduced NMR, CPD, and lung cancer risk. We confirmed the major role that CYP2A6 plays in nicotine metabolism, and made novel findings with respect to genome-wide significance and associations with CPD, abstinence and lung cancer risk. Additional multivariate analyses with patient variables and genetic modeling will improve prediction of nicotine metabolism, disease risk and smoking cessation treatment prognosis.

Effect of reducing the nicotine content of cigarettes on cigarette smoking behavior and tobacco smoke toxicant exposure: 2-year follow up.

BACKGROUND AND AIMS: A broadly mandated reduction of the nicotine content (RNC) of cigarettes has been proposed in the United States to reduce the addictiveness of cigarettes, to prevent new smokers from becoming addicted and to facilitate quitting in established smokers. The primary aim of this study was to determine whether following 7 months of smoking very low nicotine content cigarettes (VLNC), and then returning to their own cigarettes, smokers would demonstrate persistently reduced nicotine intake compared with baseline or quit smoking. METHODS: In a community-based clinic 135 smokers not interested in quitting were randomized to one of two groups. A research group smoked their usual brand of cigarettes, followed by five types of research cigarettes with progressively lower nicotine content, each for 1 month, followed by 6 months at the lowest nicotine level (0.5 mg/cigarette) (53 subjects) and then 12 months with no intervention (30 subjects completed). A control group smoked their usual brand for the same period of time (50 subjects at 6 months, 38 completed). Smoking behavior, biomarkers of nicotine intake and smoke toxicant exposure were measured. RESULTS: After 7 months smoking VLNC, nicotine intake remained below baseline (plasma cotinine 149 versus 250 ng/ml, P<0.005) with no significant change in cigarettes per day or expired carbon monoxide (CO). During the 12-month follow-up, cotinine levels in RNC smokers rose to baseline levels and to those of control smokers. Quit rates among RNC smokers were very low [7.5 versus 2% in controls, not significant). CONCLUSIONS: In smokers not interested in quitting, reducing the nicotine content in cigarettes over 12 months does not appear to result in extinction of nicotine dependence, assessed by persistently reduced nicotine intake or quitting smoking over the subsequent 12 months.

Gender differences in a randomized controlled trial treating tobacco use among adolescents and young adults with mental health concerns.

INTRODUCTION: Treatment of tobacco use in mental health settings is rare despite high rates of comorbidity. With a focus on early intervention, we evaluated a tobacco treatment intervention among adolescents and young adults recruited from outpatient, school-based, and residential mental health settings and tested for gender differences. METHODS: Intervention participants received computerized motivational feedback at baseline, 3 months, and 6 months and were offered 12 weeks of cessation counseling and nicotine patches. Usual care participants received a self-help guide and brief cessation advice. We examined 7-day point prevalence abstinence with biochemical confirmation at 3, 6, and 12 months; smoking reduction; and 24-hr quit attempts. RESULTS: At baseline, the sample (N = 60, 52% female, mean age = 19.5±2.9 years, 40% non-Hispanic Caucasian) averaged 7±6 cigarettes/day, 62% smoked daily, 38% smoked ≤ 30 min of waking, 12% intended to quit in the next month, 47% had a parent who smoked, and 3 of 5 of participants' closest friends smoked on average. During the 12-month study, 47% of the sample reduced their smoking, 80% quit for 24 hr, and 11%, 13%, and 17% confirmed 7-day point prevalence abstinence at 3-, 6-, and 12-month follow-up, respectively, with no differences by treatment condition (ps > .400). Over time, abstinence was greater among girls (adjusted odds ratio [AOR] = 8.9) than among boys, and abstinence was greater for lighter smokers than heavier smokers (AOR = 4.5) (p < .05). No mental health or other measured variables predicted abstinence. CONCLUSIONS: Adolescent and young adult smokers with mental health concerns are a challenging group to engage and to effectively treat for tobacco addiction, particularly heavier smokers and boys. Innovative approaches are needed.

If at first you don't succeed: characterization of smokers with late smoking abstinence onset.

INTRODUCTION: Most cigarette smoking cessation research has aimed to clarify characteristics associated with initial and sustained abstinence, with less attention paid to predictors of gaining abstinence following an initial failure. METHODS: The current investigation explored pre-treatment demographic, smoking, and psychiatric characteristics related to gaining abstinence among smokers who failed to attain initial abstinence. Participants were 809 individuals enrolled in extended, 52-week, smoking cessation interventions. Of these, 287 (62.4%) failed to achieve initial abstinence. Gaining abstinence following initial abstinence failure was defined as achieving seven-day point prevalent abstinence at any post-initial abstinence assessment. RESULTS: Those who gained abstinence (Gainers) were more likely to have a live-in partner (χ(2)(1, N=283)=3.8, p=.05, Cramér's V=.12), identify as Hispanic (χ(2)(1, N=281)=7.8, p<.01, Cramér's V=.17), evidence lower baseline expired breath carbon monoxide (F(1, 284)=5.7, p=.02, η(2)=.02), report less cigarette dependence (F(1, 278)=7.1, p<.01, η(2)=.03), and report past week cannabis use (χ(2)(1, N=284)=5.6, p=.02, Cramér's V=.14). A logistic regression model suggested that having a live-in partner (OR=5.14, 95% CI=1.09-3.02, p=.02) and identifying as Hispanic (OR=4.93, 95% CI=1.20-18.77, p=.03) increased the odds of gaining abstinence. DISCUSSION: Having a live-in partner, Hispanic status, greater cigarette dependence, and recent cannabis use were associated with gaining abstinence. These findings provide insight into an understudied area, contributing an initial framework toward understanding gaining abstinence following initial failure.

Smoking cessation abstinence goal in treatment-seeking smokers.

INTRODUCTION: Baseline abstinence goal is a robust predictor of cigarette abstinence. However, important questions about goal remain unanswered. These include variables correlating with goal, changes in goal, relationship of goal and abstinence status over time, and predictors of change. The current study aimed to address these questions. METHOD: Participants were treatment-seeking volunteers in two clinical trials. In Clinical Trial 1 (N=402), participants smoked ≥10 cigarettes per day (CPD) and were ≥50years of age. In Clinical Trial 2 (N=406), participants smoked ≥10 CPD, smoked within 30min of arising, and were ≥18years of age. The outcome variables were biochemically verified 7-day abstinence from cigarettes at weeks 12, 24, 52, and 104. Abstinence goal, demographic, psychological, and smoking related variables were assessed via standard instruments. RESULTS: At baseline, the greater the desire to quit and one's expectations of success, and the lesser the educational level, the more likely participants were to have a quit forever goal. Throughout the two-year study, abstinence from cigarettes and a lower educational level were correlated with a goal of quit forever; 37% of participants changed goal. There were no predictors of goal change. Abstinence goal was related to abstinence status across the study period. The goal predicted abstinence status at subsequent assessments, even when status was controlled. CONCLUSION: Lesser educational levels were consistent predictors of a more stringent goal. Abstinence goal changes over time. These findings suggest that repeated counseling about goal is advisable and participants would benefit from such counseling, independent of demographic characteristics and smoking status.

Organic cation transporter variation and response to smoking cessation therapies.

INTRODUCTION: We evaluated chr6q25.3 organic cation transporter gene (SLC22A1, SLC22A2, SLC22A3) variation and response to smoking cessation therapies. The corresponding proteins are low-affinity transporters of choline, acetylcholine and monoamines, and smoking cessation pharmacotherapies expressed in multiple tissues. METHODS: We selected 7 common polymorphisms for mega-regression analysis. We assessed additive model association of polymorphisms with 7-day point prevalence abstinence overall and by assigned pharmacotherapy at end of treatment and at 6 months among European-ancestry participants of 7 randomized controlled trials adjusted for demographic, population genetic, and trial covariates. RESULTS: Initial results were obtained in 6 trials with 1,839 participants. Nominally statistically significant associations of 2 SLC22A2 polymorphisms were observed: (1) with rs316019 at 6 months, overall ([c.808T>G; p.Ser270Ala], OR = 1.306, 95% CI = 1.034-1.649, p = .025), and among those randomized to nicotine replacement therapy (NRT) (OR = 1.784, 95% CI = 1.072-2.970, p = .026); and (2) with rs316006 (c.1502-529A>T) among those randomized to varenicline (OR = 1.420, 95% CI = 1.038-1.944, p = .028, OR = 1.362, 95% CI = 1.001-1.853, p = .04) at end of treatment and 6 months. Individuals randomized to NRT from a seventh trial were genotyped for rs316019; rs316019 was associated with a nominally statistically significant effect on abstinence overall at 6 months among 2,233 participants (OR = 1.249, 95% CI = 1.007-1.550, p = .043). CONCLUSIONS: The functional OCT2 Ser270Ala polymorphism is nominally statistically significantly associated with abstinence among European-ancestry treatment-seeking smokers after adjustments for pharmacotherapy, demographics, population genetics, and without adjustment for multiple testing of 7 SNPs. Replication of these preliminary findings in additional randomized controlled trials of smoking cessation therapies and from multiple continental populations would describe another pharmacogenetic role for SLC22A2/OCT2.

PTSD symptomatology and readiness to quit smoking among women with serious mental illness.

INTRODUCTION: Posttraumatic stress disorder (PTSD) is a risk factor for tobacco addiction. The majority of research on PTSD and smoking has been conducted with men, particularly combat veterans, and little is known about the association among women. In a clinical sample of women civilian smokers with serious mental illness (SMI), we examined the prevalence of PTSD symptomatology and associations with physical and mental health functioning, co-occurring substance use, nicotine dependence, and readiness to quit smoking. METHODS: 376 adult women smokers aged 18-73 were recruited from 7 acute inpatient psychiatry units and screened by diagnostic interview for current PTSD symptomatology (PTSD(+)). In multiple regressions, we examined the associations of screening PTSD(+) with physical and mental health functioning; past-month drug use; past-year substance use disorders; nicotine dependence and readiness to quit smoking. RESULTS: Nearly half the sample (43%) screened PTSD(+), which was significantly associated with the use of stimulants (OR=1.26) and opiates (OR=1.98), drug use disorders (OR=2.01), and poorer mental health (B=-2.78) but not physical health functioning. PTSD(+) status was unrelated to nicotine dependence, but predicted greater desire to quit smoking (B=2.13) and intention to stop smoking in the next month (OR=2.21). In multivariate models that adjusted for substance use disorders, physical and mental health functioning, and nicotine dependence, screening PTSD(+) remained predictive of greater desire and intention to quit smoking. CONCLUSION: PTSD symptomatology was common in our sample of women smokers with SMI and associated with not only worse substance use and mental health, but also greater readiness to quit smoking, suggesting the need for and potential interest in integrative PTSD-addiction treatment among women.

Smoking cessation outcomes among sexual and gender minority and nonminority smokers in extended smoking treatments.

INTRODUCTION: Sexual and gender minority individuals (i.e., lesbian, gay, bisexual, and transgender [LGBT]) have a higher smoking prevalence than nonminority individuals. There is limited evidence of smoking abstinence success in nontailored smoking treatments among LGBT smokers. METHODS: This study is a secondary data analysis comparing the efficacy of extended, nontailored treatments among sexual and gender minority and nonminority smokers. Data from two clinical trials were combined to increase power and generalizability of the findings. Trials began with 12 weeks of counseling, nicotine replacement, and bupropion, after which participants were randomized to an extended treatment. RESULTS: Follow-up occurred at weeks 12, 24, 52, 64, and 104. Of the sample (n = 777), 17% identified as sexual and gender minority and 83% as nonminority. The sample was 75% non-Hispanic White, with 86% completing at least some college, and 68% were employed. Sexual and gender minorities were younger and indicated a greater desire to quit smoking than nonminority smokers. No other differences emerged on demographic, smoking, or mood variables. The average Fagerström Test for Nicotine Dependence score was 4.8, and mean daily cigarettes was 19.8. The generalized estimating equations model revealed no significant differences in abstinence between sexual and gender minority smokers and nonminority smokers at all follow-up assessments. CONCLUSIONS: Sexual and gender minority smokers appear as likely to quit or abstain as nonminority smokers in extended, nontailored interventions. However, these findings may not generalize to other geographic areas, where access to treatment is limited or a higher stigma of sexual orientation exists.

Multiple risk-behavior profiles of smokers with serious mental illness and motivation for change.

OBJECTIVE: Individuals with serious mental illness (SMI) are dying on average 25 years prematurely. The leading causes are chronic preventable diseases. In the context of a tobacco-treatment trial, this exploratory study examined the behavioral risk profiles of adults with SMI to identify broader interventional needs. METHOD: Recruited from five acute inpatient psychiatry units, participants were 693 adult smokers (recruitment rate = 76%, 50% male, 45% Caucasian, age M = 39, 49% had income < $10,000) diagnosed with mood disorders (71%), substance-use disorders (63%), posttraumatic stress disorder (39%), psychotic disorders (25%), and attention deficit-hyperactivity disorder (25%). The Staging Health Risk Assessment, the primary measure used in this study, screened for risk status and readiness to change 11 health behaviors, referencing the period prior to acute hospitalization. RESULTS: Participants averaged 5.2 (SD = 2.1) risk behaviors, including smoking (100%), high-fat diet (68%), inadequate fruits/vegetables (67%), poor sleep (53%), physical inactivity (52%), and marijuana use (46%). The percent prepared to change ranged from 23% for tobacco and marijuana to 76% for depression management. Latent class analysis differentiated three risk groups: the global higher risk group included patients elevated on all risk behaviors; the global lower risk group was low on all risks; and a mood and metabolic risk group, characterized by inactivity, unhealthy diet, sleep problems, and poor stress and depression management. The global higher risk group (11% of sample) was younger, largely male, and had the greatest number of risk behaviors and mental health diagnoses; had the most severe psychopathologies, addiction-treatment histories, and nicotine dependence; and the lowest confidence for quitting smoking and commitment to abstinence. CONCLUSION: Most smokers with SMI engaged in multiple risks. Expanding targets to treat co-occurring risks and personalizing treatment to individuals' multibehavioral profiles may increase intervention relevance, interest, and impact on health.