Abstract

Introduction: Tobacco smoking is the largest contributor to markedly elevated CVD and preventable death in persons with SMI. Trials of combined pharmacologic and behavioral treatments improve abstinence rates, but have targeted those ready to quit right away, and evidence-based treatments are rarely used in the community. Weight gain often accompanies abstinence. Our objective was to determine the effectiveness of an 18m smoking cessation pharmacotherapy and behavioral counseling intervention incorporating weight management and physical activity in persons with SMI. Hypothesis: The active intervention is more effective than control in achieving biochemically validated, 7-day point prevalence smoking abstinence at 18m. Methods: We conducted an RCT in 4 community mental health settings in 192 smokers with SMI, stratified by readiness to quit within 30d or in 1 to 6m. The active intervention group was offered 18m of 1 st -line cessation pharmacotherapy, smoking cessation and weight management counseling tailored to readiness to quit, and support for physical activity. Controls received a quit line referral. Results: Mean(SD) age was 49.6(11.7); cigarettes/day 12.1(9.5); BMI 32.0(7.6) kg/m 2 ; 49% were male, 48% African-American, 62% willing to quit in 30d, 95% completed 18m follow-up. At 18m, 27.8% of active group and 6.3% of controls achieved 7d smoking abstinence (p<0.0001); adjusted odds ratio 6.0 (95% CI: 2.3 –15.6; p=0.0002). There was no significant modification of intervention effect on abstinence by readiness to quit. Mean difference in weight change over 18m between active and control was not significant (3.5 lbs, 95% CI: -3.3 –10.3; p=0.32). Conclusions: Offering 18m of evidence-based cessation treatment in the community substantially increased smoking abstinence without significant weight gain in SMI. Implementing best practice guidelines to treat all smokers regardless of readiness to quit should improve CVD health in this high-risk population.

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