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.

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).