A randomized clinical trial testing two implementation strategies to promote the treatment of tobacco dependence in community mental healthcare.

INTRODUCTION: People with serious mental illness (SMI) are more likely to smoke and less likely to receive tobacco treatment. Implementation strategies may address clinician and organizational barriers to treating tobacco in mental healthcare. METHODS: A cluster-randomized trial (Clinic N=13, Client N=610, Staff N=222) tested two models to promote tobacco treatment in community mental healthcare: standard didactic training vs. Addressing Tobacco Through Organizational Change (ATTOC), an organizational model that provides clinician and leadership training and addresses system barriers to tobacco treatment. Primary outcomes were changes in tobacco treatment from clients, staff, and medical records. Secondary outcomes were changes in smoking, mental health, and quality of life (QOL), and staff skills and barriers to treat tobacco. RESULTS: Clients at ATTOC sites reported a significant increase in receiving tobacco treatment from clinician at weeks 12 and 24 (ps<0.05) and tobacco treatments and policies from clinics at weeks 12, 24, 36, and 52 (ps<0.05), vs. standard sites. ATTOC staff reported a significant increase in skills to treat tobacco at week 36 (p=0.05), vs. standard sites. For both models, tobacco use medications, from clients (week 52) and medical records (week 36), increased (ps<0.05), while perceived barriers decreased at weeks 24 and 52 (ps<0.05); 4.3% of clients quit smoking which was not associated with model. QOL and mental health improved over 24 weeks for both models (ps<0.05). CONCLUSIONS: Standard training and ATTOC improve use of evidence-based tobacco treatments in community mental healthcare without worsening mental health, but ATTOC may more effectively address this practice gap.

Medication adherence and rate of nicotine metabolism are associated with response to treatment with varenicline among smokers with HIV.

INTRODUCTION: PLWHA who smoke have shown lower cessation rates within placebo-controlled randomized trials of varenicline. Adherence and rate of nicotine metabolism may be associated with quit rates in such clinical trials. METHODS: This secondary analysis of a randomized placebo-controlled trial of varenicline for smoking among PLWHA (N = 179) examined the relationship between varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation (self-reported 7-day point prevalence abstinence, confirmed with carbon monoxide of ≤ 8 ppm, at the end of treatment; EOT). RESULTS: Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates. In separate models, adherence (OR = 1.009, 95% CI:1.004-1.01, p < 0.001) and nicotine metabolism rate (OR = 2.04, 95% CI:1.19-3.49, p = 0.009) interacted with treatment arm to effect quit rates. The quit rate for varenicline vs. placebo was higher for both non-adherent (19% vs. 5%; χ2[1] = 2.80, p = 0.09) and adherent (35% vs. 15%; χ2[1] = 6.51, p = 0.01) participants, but the difference between treatment arms was statistically significant only for adherent participants. Likewise, among slow metabolizers (NMR < 0.31), the varenicline quit rate was not significantly higher vs. placebo (14% vs. 5%; χ2[1] = 1.17, p = 0.28) but, among fast metabolizers (NMR ≥ 0.31), the quit rate for varenicline was significantly higher vs. placebo (33% vs. 14%; χ2[1] = 4.43, p = 0.04). CONCLUSIONS: Increasing varenicline adherence and ensuring that fast nicotine metabolizers receive varenicline may increase quit rates for PLWHA.

Assessing barriers to providing tobacco use disorder treatment in community mental health settings with a revised version of the Smoking Knowledge, Attitudes, and Practices (S-KAP) instrument.

BACKGROUND: Tobacco use disorder (TUD) rates are 2-3 times higher among people with serious mental illness (SMI) than the general population. Clinicians working in outpatient community mental health clinics are well positioned to provide TUD treatment to this group, but rates of treatment provision are very low. Understanding factors associated with the provision of TUD treatment by mental health clinicians is a priority. METHODS: This study used baseline data from an ongoing cluster-randomized clinical trial evaluating two approaches to training clinicians to increase TUD treatment. Following a psychometric assessment of our assessment tool, the Smoking Knowledge, Attitudes, and Practices (S-KAP) instrument, a new factor structure was evaluated utilizing confirmatory factor analysis. Structural equation modeling was then used to examine the associations between TUD treatment practices and clinician, setting, and patient characteristics in a sample of 182 mental health clinicians across 10 mental health clinics. RESULTS: Clinician but not setting or patient characteristics emerged as significant correlates of providing TUD treatment. Specifically, clinicians' general ethical commitment to providing TUD services and perceptions of their skills in providing this type of care were associated with providing TUD treatment. In contrast, clinician perceptions of patient motivation, anticipated quit rates, or available setting resources were not significantly associated with providing TUD treatment. CONCLUSIONS: Enhancing community mental health clinician TUD treatment skills and commitment to providing such services may reduce TUD rates among people with SMI. Future studies should evaluate interventions that target these factors.

The Use of the Nicotine Metabolite Ratio as a Biomarker to Personalize Smoking Cessation Treatment: Current Evidence and Future Directions.

The nicotine metabolite ratio (NMR), a genetically informed biomarker of rate of nicotine metabolism, has been validated as a tool to select the optimal treatment for individual smokers, thereby improving treatment outcomes. This review summarizes the evidence supporting the development of the NMR as a biomarker of individual differences in nicotine metabolism, the relationship between the NMR and smoking behavior, the clinical utility of using the NMR to personalize treatments for smoking cessation, and the potential mechanisms that underlie the relationship between NMR and smoking cessation. We conclude with a call for additional research necessary to determine the ultimate benefits of using the NMR to personalize treatments for smoking cessation. These future directions include measurement and other methodologic considerations, disseminating this approach to at-risk subpopulations, expanding the NMR to evaluate its efficacy in predicting treatment responses to e-cigarettes and other noncigarette forms of nicotine, and implementation science including cost-effectiveness analyses.See all articles in this Special Collection Honoring Paul F. Engstrom, MD, Champion of Cancer Prevention.

Improved clinical outcomes among persons with HIV who quit smoking.

Quitting smoking among people living with HIV/AIDS (PLWHA) is a priority. However, PLWHA and clinicians working with PLWHA are reluctant to use tobacco use treatments out of concern that smoking cessation can diminish anti-retroviral therapy (ART) adherence and quality of life (QoL) and increase psychiatric symptoms. This secondary analysis from a placebo-controlled varenicline trial for tobacco dependence among PLWHA (N = 179) examined if smoking cessation at the end of treatment (EOT) was associated with changes in ART adherence, QoL, anxiety and depression symptoms, and varenicline side effects. ART adherence was not affected by smoking cessation (p > 0.05), remaining ≥98% for all participants. Across 8 QoL subscales, 7 remained unchanged over time across smokers and abstainers; side effects were not associated with cessation. Controlling for baseline smoking rate, adherence to varenicline/placebo and counseling, and treatment arm, participants who had quit smoking at EOT reported a significant reduction in depression (ß = -1.657, 95% CI: -2.893, -0.422, p = .009) and anxiety (ß = -1.434, 95% CI: -2.812, -0.56, p = .041) and increased life satisfaction (ß = 0.88, 95% CI: 0.21, 3.275, p = .027). When PLWHA quit smoking they may not experience adverse clinical outcomes including ART non-adherence and may experience beneficial psychological effects, supporting the use of FDA-approved smoking cessation treatments among PLWHA.

History and Correlates of Smoking Cessation Behaviors Among Smokers With Serious Mental Illness.

INTRODUCTION: Individuals with serious mental illness (SMI) smoke at rates two to three times greater than the general population but are less likely to receive treatment. Increasing our understanding of correlates of smoking cessation behaviors in this group can guide intervention development. AIMS AND METHODS: Baseline data from an ongoing trial involving smokers with SMI (N = 482) were used to describe smoking cessation behaviors (ie, quit attempts, quit motivation, and smoking cessation treatment) and correlates of these behaviors (ie, demographics, attitudinal and systems-related variables). RESULTS: Forty-three percent of the sample did not report making a quit attempt in the last year, but 44% reported making one to six quit attempts; 43% and 20%, respectively, reported wanting to quit within the next 6 months or the next 30 days. Sixty-one percent used a smoking cessation medication during their quit attempt, while 13% utilized counseling. More quit attempts were associated with lower nicotine dependence and carbon monoxide and greater beliefs about the harms of smoking. Greater quit motivation was associated with lower carbon monoxide, minority race, benefits of cessation counseling, and importance of counseling within the clinic. A greater likelihood of using smoking cessation medications was associated with being female, smoking more cigarettes, and receiving smoking cessation advice. A greater likelihood of using smoking cessation counseling was associated with being male, greater academic achievement, and receiving smoking cessation advice. CONCLUSIONS: Many smokers with SMI are engaged in efforts to quit smoking. Measures of smoking cessation behavior are associated with tobacco use indicators, beliefs about smoking, race and gender, and receiving cessation advice. IMPLICATIONS: Consideration of factors related to cessation behaviors among smokers with SMI continues to be warranted, due to their high smoking rates compared to the general population. Increasing our understanding of these predictive characteristics can help promote higher engagement in evidence-based smoking cessation treatments among this subpopulation.

Correlates of varenicline adherence among smokers with HIV and its association with smoking cessation.

INTRODUCTION: With medical advances, the life expectancy of people living with HIV/AIDS (PLWHA) has improved; however, tobacco use remains a prominent risk for mortality. Although studies have examined the efficacy of varenicline for treating smoking among PLWHA, the relationship between varenicline adherence and cessation and correlates of varenicline adherence remain under-studied. METHODS: We conducted secondary analyses from a randomized placebo-controlled trial of varenicline for smoking among PLWHA, using data from participants who received varenicline (N = 89). The relationship between varenicline adherence (based on pill count) and end-of-treatment smoking cessation was assessed, as were correlates of varenicline adherence. RESULTS: Those who were abstinent took an average of 137.1 pills (SD = 39.3), or 83% of pills prescribed, vs. 105.3 pills (SD = 64.1), or 64%, for those who were smoking (OR = 1.01, 95% CI: 1.001-1.021, p = 0.03); 52/89 (58%) participants were adherent based on taking ≥80% of pills. The quit rate for adherent participants was 35% (18/52) vs. 19% (7/37) for non-adherent participants. Adherent participants were older, smoked fewer cigarettes each day, started smoking at an older age, and had lower baseline creatinine vs. non-adherent participants (p < 0.05). There was a significant time-by-group interaction effect for anxiety (F[1,72] = 6.24, p = 0.02), depression (F[1,72] = 4.2, p = 0.04), and insomnia (F[1,72] = 7.73, p = 0.007), indicating that adherent participants had less depression, anxiety, and insomnia during the initial weeks of treatment, vs. non-adherent participants. CONCLUSIONS: Our findings underscore the importance of varenicline adherence for determining cessation and highlight the role of early changes in anxiety, depression, and insomnia determining varenicline adherence.

Predictors of Varenicline Adherence Among Cancer Patients Treated for Tobacco Dependence and its Association With Smoking Cessation.

INTRODUCTION: The degree to which smokers adhere to pharmacotherapy predicts treatment success. The development of interventions to increase adherence requires identification of predictors of treatment adherence, particularly among specific clinical populations. METHODS: Using data from a 12-week open-label phase of a clinical trial of varenicline for tobacco dependence among cancer patients (N = 207), we examined: (1) the relationship between self-reported varenicline adherence and verified smoking cessation and (2) demographic and disease-related variables, and early changes in cognition, affect, withdrawal, the reinforcing effects of smoking, and medication side effects, as correlates of varenicline adherence. RESULTS: At the end of 12 weeks, 35% of the sample had quit smoking and 52% reported taking ≥80% of varenicline. Varenicline adherence was associated with cessation (p < .001): 58% of participants who were adherent had quit smoking versus 11% of those who were not. Participants who experienced early reductions in depressed mood and satisfaction from smoking and experienced an increase in the toxic effects of smoking, showed greater varenicline adherence (p < .05); the relationship between greater adherence and improved cognition, reduced craving, and reduced sleep problems and vomiting approached significance (p < .10). CONCLUSIONS: Among cancer patients treated for tobacco dependence with varenicline, adherence is associated with smoking cessation. Initial changes in depressed mood and the reinforcing effects of smoking are predictive of adherence. IMPLICATIONS: The benefits of varenicline for treating tobacco dependence among cancer patients may depend upon boosting adherence by addressing early signs of depression and reducing the reinforcing dimensions of cigarettes.

A Cluster-Randomized Clinical Trial Testing the Effectiveness of the Addressing Tobacco Through Organizational Change Model for Improving the Treatment of Tobacco Use in Community Mental Health Care: Preliminary Study Feasibility and Baseline Findings.

INTRODUCTION: People with mental illness are more likely to smoke and less likely to receive tobacco treatment than the general population. The Addressing Tobacco Through Organizational Change (ATTOC) approach supports organizational change to increase tobacco treatment in this population. We describe preliminary study feasibility and baseline behaviors and attitudes among clients and staff regarding tobacco treatment, and assesse correlates of treatment of smoking. METHODS: Preliminary accrual, engagement, and baseline data are reported from a cluster-randomized trial comparing ATTOC to usual care. Feasibility, thus far, was the rate of site and participant accrual and engagement (eg, participants remaining in the trial). Correlates of assessing smoking, advising cessation, and providing treatment were assessed. RESULTS: Site and participant accrual is 80% (8/10) and 86% (456/533), and engagement is 100% and 82%. "Staff asking about smoking" was reported by 63% of clients and 38% of staff; "staff advising cessation" was reported by 57% of clients and 46% of staff; staff report "assisting clients with any medication" at most 22% of the time, whereas at most 18% of clients report receiving a cessation medication; 59% of clients want tobacco treatment, but 36% of staff think that it is part of their job. "Staff assisting with medications" is related to more training, believing treating smoking is part of their job, and believing patients are concerned about smoking (ps < .05). CONCLUSIONS: This trial of training in tobacco treatment within mental health care is feasible thus far; self-reported rates of tobacco treatment are low and associated with clinician attitudes and barriers. IMPLICATIONS: Evaluation of ways to help address tobacco use treatment in community mental health care is feasible and needed, including the use of technical assistance and training guided by an organizational change approach.