Predictors of improved clinician screening, assessment, and treatment for tobacco use for clients in community mental healthcare following training.

Introduction: People with mental illness (MI) are more likely to smoke cigarettes and less likely to receive treatment for tobacco use than the general population. Understanding factors associated with improved staff treatment of tobacco use in community mental health settings has received limited study. Methods: We used data from a completed cluster-randomized clinical trial that tested two interventions designed to increase treatment for tobacco use in mental health clinics. Among 222 clinic staff, we examined demographic and employment characteristics, changes in perceived skills, knowledge, and beliefs using the S-KAP (i.e., perceptions of staff responsibility to treat tobacco use; client quit motivation; client outcomes; and barriers) as predictors of change in clinician reported delivery of tobacco use treatment following training. Results: Clinician reported treatment of client tobacco use significantly increased from baseline to week 52 across both study arms (p<0.001). This increase in reported treatment for tobacco use was associated with increases from baseline to week 52 in clinician reported skills to treat tobacco use, perceptions of responsibility to treat client tobacco use, and perceptions about client motivation to quit smoking (p's<0.05). Conclusions: Training clinicians in community mental healthcare to address client tobacco use may improve outcomes by helping them to develop the needed skills, convincing them that treating tobacco use is part of their role as clinicians, and by helping clinicians to recognize that clients are motivated to quit smoking. These may be targets to improve how clinicians in community health settings address client tobacco use.

Depression Severity Moderates Reward Learning Among Smokers with Current or Past Major Depressive Disorder in a Smoking Cessation Randomized Clinical Trial.

INTRODUCTION: Behavioral and pharmacological smoking cessation treatments are hypothesized to increase patients' reward learning to reduce craving. Identifying changes in reward learning processes that support effective tobacco dependence interventions among smokers who experience depression may guide patients towards efficient treatment strategies. The objective was to investigate the extent to which adult daily cigarette smokers with current or past major depressive disorder (MDD) learned to seek reward during 12 weeks of treatment combining behavioral activation and varenicline. We hypothesized that a decline in reward learning would be attenuated (least to most) in the following order: 1) Behavioral activation integrated with ST (BASC) + varenicline, 2) BASC + placebo, 3) Standard behavioral cessation treatment (ST) + varenicline, 4) ST + placebo. METHODS: We ran a Phase 4, placebo-controlled, randomized clinical trial with 300 participants receiving 12 weeks of one of four conditions across two urban medical centers. Depressive symptoms were measured using the Beck Depression Inventory-II (BDI). Reward learning was ascertained at Weeks 1, 7, and 14 using the Probabilistic Reward Task (PRT), a laboratory task that uses an asymmetric reinforcement schedule to assess (a) learning to seek reward (response bias), (b) differentiate between stimuli, and (c) time to react to cues. RESULTS: There was a significant interaction of BDI group x PRT response bias. Response bias declined from Week 7 to 14 among participants with high baseline depression symptoms. The other two BDI groups showed no change in response bias. CONCLUSIONS: Controlling for baseline depression, participants showed a decrease in response bias from Week 1 to 14, and from Weeks 7 to 14. Treatment condition and abstinence status were unassociated with change in reward learning. IMPLICATIONS: Smokers who report greater depression severity show a decline in reward learning despite their participation in smoking cessation treatments, suggesting that depressed populations pose unique challenges with standard smoking cessation approaches.

Seeing Through the Blind: Belief about Treatment Randomization and Smoking Cessation Outcome among People with Current or Past Major Depressive Disorder who Smoke in a Placebo-Controlled Trial of Varenicline.

INTRODUCTION: Blinding participants to randomization is a cornerstone of science. However, participant beliefs about their allocation can influence outcomes. We examined blind integrity, the association between trial arm belief and cessation, and potential mechanisms linking treatment arm and treatment arm belief among people with major depressive disorder (MDD) who smoke receiving varenicline in a placebo-controlled trial. METHODS: 175 participants were asked at the end of treatment (EOT) if they thought they received placebo, varenicline, or were not sure. We assessed the relationship between treatment arm belief and actual treatment allocation, examined the association between treatment arm belief and EOT cessation, and evaluated changes in craving, withdrawal, side effects, depression symptoms, and smoking reward as mediators through which treatment arm was believed. RESULTS: Treatment arm belief was significantly associated with actual arm assignment (χ2(2)=13.0, p=0.002). Participants in the varenicline arm were >3 times as likely to believe they were taking varenicline, vs. "not sure" (RR=3.05 [1.41-6.60], p=0.005). Participants in the placebo arm were just as likely to believe they were taking placebo vs. "not sure" (χ2[2]=0.75, p=0.69). Controlling for treatment arm, belief that one received varenicline was significantly associated with an increase in cessation rate (OR=5.91 [2.06-16.92], p=0.001). Change in the rewarding experience of smoking may mediate participant ability to discern getting varenicline B=0.077 [0.002-0.192], p <0.05). CONCLUSIONS: Participants receiving varenicline can discern that they received varenicline and this belief is associated with higher cessation rates. Research is needed to continue to examine how participants correctly identify their allocation to varenicline.

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.

Treatment adherence in a smoking cessation clinical trial for individuals with current or past major depressive disorder: Predictors and association with cessation.

INTRODUCTION: Individuals with major depressive disorder (MDD) exhibit high rates of tobacco use and lower responsiveness to tobacco cessation treatments. Treatment adherence is a strong predictor of treatment outcomes in the general population but has not been evaluated in this under-served community of smokers with MDD. METHODS: We used data from a randomized clinical trial on smoking cessation treatment among 300 smokers with MDD to examine the rate of adherence (medication and counseling), the association of adherence with cessation outcomes, and factors associated with adherence, including demographic and smoking characteristics, psychiatric characteristics, smoking cessation processes (e.g., withdrawal, reinforcers), and treatment-related side effects (e.g., nausea). RESULTS: Overall, 43.7% of participants were adherent with medication and 63.0% were adherent with counseling. Medication adherence was significantly associated with cessation, with 32.1% of adherent vs. 13.0% of non-adherent participants quitting smoking at EOT. Counseling adherence was also significantly associated with cessation, with 32.3% of adherent vs. 2.7% of non-adherent participants quitting smoking. Multivariate regression models showed that medication adherence was associated with higher engagement in complementary reinforcers and higher baseline smoking reward, while counseling adherence was associated with identifying as female, lower alcohol use and nicotine dependence, higher baseline smoking reward, and higher engagement in substitute and complementary reinforcers within the first weeks of medication use. CONCLUSIONS: As with the general population of smokers, non-adherence to treatment in smokers experiencing depression is widespread and a significant barrier to cessation. Interventions that target reinforcers may improve rates of treatment adherence.

History and Correlates of Smoking Cessation Behaviors Among Individuals With Current or Past Major Depressive Disorder Enrolled in a Smoking Cessation Trial.

INTRODUCTION: Smoking among adults with major depressive disorder (MDD) is at least double that of the general US population. More effective smoking cessation interventions for depressed smokers may be facilitated through a better understanding of the smoking and depression-related characteristics of this population. METHODS: We used baseline data from 300 participants enrolled in randomized clinical trial for smokers with current or past MDD. We described history of smoking cessation behaviors (ie, quit attempts, quit motivation, and cessation treatment utilization) and used multivariate regression to identify demographic and depression-related correlates of these behaviors. RESULTS: Sixty-eight percent of participants reported at least one quit attempt in the past year, nearly 51% reported motivation to quit in the subsequent 30 days, and 83% reported prior use of a nicotine replacement therapy. A greater readiness to quit smoking was associated with increased age (p = .04) and lower cigarettes per day (p = .01). Greater use of smoking cessation medication was associated with greater education and nicotine dependence, minority race, and greater use of complementary reinforcers (eg, activities associated with increased reinforcing value of smoking; p's < .05). CONCLUSIONS: These data indicate that smokers with current or past MDD are highly motivated to quit smoking and have a history of engaging in efforts to quit. Interventions to promote smoking cessation behaviors should address younger and lighter smokers, who may perceive less risk from tobacco use, and efforts to promote smoking cessation medications and counseling should address minority smokers who are engaging in complementary reinforcers. IMPLICATIONS: These data are inconsistent with the assumption that smokers with serious mental illness are not willing to quit smoking and suggest the need for studies that test behavioral interventions that address complementary reinforcers to treat tobacco use in this community.

Rationale and design of a randomized factorial clinical trial of pharmacogenetic and adherence optimization strategies to promote tobacco cessation among persons with HIV.

BACKGROUND: Tobacco use is approximately three times more common in people living with HIV (PLWH) than the general population. Moreover, current behavioral and pharmacological smoking cessation interventions are less effective for PLWH, highlighting a need for novel ways to optimize tobacco cessation treatments in this group. Prior research indicates that personalized treatment based on the nicotine metabolite ratio (NMR), a biomarker of nicotine metabolism, and augmenting smoking cessation medication adherence may improve cessation treatment for PLWH. METHODS: In this 2 × 2 factorial design trial, 488 smokers with HIV receive 12 weeks of smoking cessation medication along with randomization to 1) tailor the smoking cessation drug to their metabolism or not, and 2) provide additional counseling on smoking cessation medication adherence or not. Those randomized to the pharmacogenetic optimization arm receive varenicline or the nicotine patch based on their NMR (varenicline for fast metabolizers and the nicotine patch for slow metabolizers) and those in the control arm receive varenicline. Those randomized to the experimental adherence counseling arm receive Managed Problem Solving (MAPS) targeting their smoking cessation medication and those in the control arm receive standard counseling. CONCLUSION: PLWH on suppressive antiretroviral therapy who smoke lose more life-years due to tobacco use than to their HIV infection, and have lower response rates to current evidence-based treatments for smoking cessation. Both the NMR tailoring and MAPS interventions have the potential to optimize treatments for tobacco use among this population. If effective, this trial may demonstrate ways to further improve long-term health outcomes for PLWH.

Comparing the Rate of Nicotine Metabolism Among Smokers With Current or Past Major Depressive Disorder.

BACKGROUND AND OBJECTIVES: Persons with current or past major depressive disorder (MDD) vs those without have higher smoking rates. The nicotine metabolite ratio (NMR) represents variation in the rate of nicotine metabolism and has been associated with smoking behaviors and response to tobacco treatments. We compared NMR between smokers with current or past MDD (MDD+) vs smokers without MDD (MDD-). We also assessed correlates of NMR and compared withdrawal and craving between MDD+ and MDD- smokers. METHODS: Using baseline data from two clinical trials and propensity score weighting based on sex, race, body mass index, and smoking rate, we compared NMR between MDD+ (N = 279) and MDD- (N = 1575) smokers. We also compared groups on and nicotine withdrawal and craving. RESULTS: Mean NMR (ß = -.02, 95% confidence interval [CI]: -0.05 to 0.01, P = .13) and the distribution of smokers across NMR quartiles (odds ratio [OR] = 0.76, 95% CI: 0.50 to 1.16, P = .21) were similar between MDD+ and MDD- samples. This relationship was not affected by antidepressant medication. In the MDD+ sample, African Americans had significantly lower mean NMR, while older smokers and smokers with lower education had higher mean NMR (Ps < .05). MDD+ smokers had significantly higher withdrawal and craving than MDD- smokers (Ps < .05). DISCUSSION AND CONCLUSIONS: While variability in NMR may not explain differences in smoking rates between MDD+ and MDD- smokers, MDD+ smokers report increased withdrawal and craving. SCIENTIFIC SIGNIFICANCE: In this first study to assess NMR among MDD+ smokers, the findings underscore the need to address withdrawal and craving within smoking cessation treatments for those with MDD. (Am J Addict 2021;00:00-00).

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.

Rate and correlates of tobacco treatment during a primary care visit for a largely urban and African American sample of smokers.

Introduction: Evidence-based treatments for tobacco use are under-utilized and primary care visits may be an opportune time to address this gap. This study examined the rate at which primary care visits included tobacco use treatment and examined patient demographics, smoking characteristics, attitudes about tobacco use treatments, and comorbidities as correlates of treatment provision. Methods: This prospective study assessed demographics, smoking characteristics, attitudes about tobacco use treatments, and comorbidities via interview prior to a primary care visit among 105 patients. One week following the appointment, 85 patients were reassessed for the tobacco use treatments they received during their appointment (i.e., asked about their tobacco use, advised to quit, and provided with a referral to a tobacco use treatment program or an FDA-approved tobacco use medication). Results: 93% of patients were asked about their tobacco use, 74% were advised to quit, 37% were provided with a referral for tobacco use treatment, and 27% received an FDA-approved medication (16% NRT, 11% varenicline or bupropion). Patients with higher quit motivation and who endorsed that medications can reduce cravings were more likely to report receiving tobacco use medication. Patients with a self-reported substance abuse history were less likely to report receiving tobacco use medications. Conclusions: The provision of tobacco use medications within primary care remains low. Strategies to increase patient quit motivation and help patients understand that tobacco use medications can mitigate cravings may increase use. Strategies may also be needed to ensure that patients with comorbid substance abuse still receive tobacco use treatments.

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.

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.