Optimal Carbon Monoxide Criteria to Confirm 24-hr Smoking Abstinence

Introduction: The majority of people with schizophrenia have a diagnosis of tobacco dependence during their lifetime. A major obstacle to reducing the burden of cigarette smoking in this population is that these smokers have lower quit rates when undergoing standard treatment compared to smokers with no mental illness. We sought to determine if combination extended treatment (COMB-EXT) and home visits (HV) would lead to improved outcomes in smokers with schizophrenia. Methods: Thirty-four cigarette smokers with schizophrenia completed either COMB-EXT with HV, COMB-EXT without HV, or treatment as usual (TAU) (random assignment). COMB-EXT consisted of group cognitive-behavioral therapy (CBT), bupropion, nicotine patch, and nicotine lozenge, which were initiated within 2 weeks and continued for 26 weekly visits. HV consisted of biweekly visits to the home with assessment of secondhand smoke (SHS) exposure and brief behavioral therapy with participants and others in the home environment. TAU consisted of group CBT plus serial single or combination medication trials as per standard care. Results: Smokers with schizophrenia who received COMB-EXT (with or without HV) had greater reductions in cigarettes per day than those treated with TAU (both ps < .01). In addition, 7-day point prevalence abstinence rates for the three groups were 45%, 20%, and 8%, respectively, which was significantly higher for COMB-EXT plus HV than TAU (χ 2 (1) = 4.8, p = .03). Groups did not differ significantly in the number of adverse events, and HV were easily scheduled. Conclusion: COMB-EXT improves outcomes for smokers with schizophrenia. HV appeared to provide additional benefit for smoking cessation in this treatment-resistant population. Implications: The clear benefit found here of rapidly initiated, combination, extended treatment over TAU suggests that aggressive and extended treatment should be considered in clinical practice for smokers with schizophrenia. Furthermore, HV to address SHS exposure showed initial promise for assisting smokers with schizophrenia in maintaining abstinence, indicating that this intervention may be worthy of future research.

Section: Study Treatmentssupporting

confidence: 59%

Combination Extended Smoking Cessation Treatment Plus Home Visits for Smokers With Schizophrenia: A Randomized Controlled Trial

Brody

Zorick

Hubert

et al. 2016

“…With an urban sample, many of whom were unhoused, we used a CO cutpoint of 10 parts per million for abstinence, which may be less than optimal for light smokers. 61 Nevertheless, the promising findings from this study warrant a larger trial among low-income, diverse smokers with serious mental illness with assessment of costs to deliver the intervention and return on investment. Notably, in the parent trial, the intervention, evaluated in inpatient psychiatry, was found to be highly cost-effective with an incremental cost-effectiveness ratio of $428 per quality adjusted life year.…”

Section: Discussionmentioning

confidence: 88%

Treating Tobacco Dependence at the Intersection of Diversity, Poverty, and Mental Illness: A Randomized Feasibility and Replication Trial

Hickman¹,

Delucchi

Prochaska

2015

Introduction: In an ethnically-diverse, uninsured psychiatric sample with co-occurring drug/alcohol addiction, we evaluated the feasibility and reproducibility of a tobacco treatment intervention. The intervention previously demonstrated efficacy in insured psychiatric and nonpsychiatric samples with 20.0%-25.0% abstinence at 18 months. Methods: Daily smokers, recruited in 2009-2010 from psychiatric units at an urban public hospital, were randomized to usual care (on-unit nicotine replacement plus quit advice) or intervention, which added a Transtheoretical-model tailored, computer-assisted intervention, stage-matched manual, brief counseling, and 10-week post-hospitalization nicotine replacement. Results: The sample (N = 100, 69% recruitment rate, age M = 40) was 56% racial/ethnic minority, 65% male, 79% unemployed, and 48% unstably housed, diagnosed with unipolar (54%) and bipolar (14%) depression and psychotic disorders (46%); 77% reported past-month illicit drug use. Prior to hospitalization, participants averaged 19 (SD = 11) cigarettes/day for 23 (SD = 13) years; 80% smoked within 30 minutes of awakening; 25% were preparing to quit. Encouraging and comparable to effects in the general population, 7-day point prevalence abstinence for intervention versus control was 12.5% versus 7.3% at 3 months, 17.5% versus 8.5% at 6 months, and 26.2% versus 16.7% at 12 months. Retention exceeded 80% over 12 months. The odds of abstinence increased over time, predicted by higher self-efficacy, greater perceived social status, and diagnosis of psychotic disorder compared to unipolar depression. Conclusions: Findings indicate uninsured smokers with serious mental illness can engage in tobacco treatment research with quit rates comparable to the general population. A larger investigation is warranted. Inclusion of diverse smokers with mental illness in clinical trials is supported and encouraged.

“…Recruitment consisted of presentations at OB/GYN clinics, flyers and advertising on social media. Eligibility included: women 18-35 years old; stable physical/mental health; uncomplicated, single gestational pregnancy with established prenatal care; a signed letter from their OB physician confirming no pregnancy-related complications (ie, gestational diabetes, fetal growth restriction, pregnancy hypertension, history of ≥3 miscarriages, known congenital anomaly); self-report of no smoking for 4 weeks prior to study enrollment (at 32-35 weeks gestation), confirmed with carbon monoxide (CO) < 5 ppm 23 ; previous history of five cigarettes per day (CPD) for at least 6 of the past 12 months; motivated to remain abstinent after delivery (≥7 on 10-point Likerttype scale); willing to use nonhormonal birth control during the postpartum follow-up period of the study; English fluency; and ability to provide informed consent. Ineligibility items included: self-reported use of illicit drugs, nicotine replacement therapy, smoking cessation medications, or medications contraindicated to progesterone use (ie, drugs that may inhibit CYP3A4 functioning); contraindications to progesterone treatment (ie, history of thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting/bleeding disorders, stroke, heart disease, diabetes, liver dysfunction or disease, or an allergy to peanuts (progesterone capsules contain peanut oil).…”

Section: Participantsmentioning

confidence: 99%

“…Smoking status or abstinence was confirmed by breath CO measurements (CO < 5 ppm indicating abstinence) 23 serum cotinine (<4.47 ng/ml indicating abstinence) 41 analysis and self-report via the Timeline Followback procedure 33,34 at each clinic visit. Cotinine levels for weeks 0, 4, and 12 were analyzed.…”

Section: Smoking Statusmentioning

confidence: 99%

Progesterone and Postpartum Smoking Relapse: A Pilot Double-Blind Placebo-Controlled Randomized Trial

Allen

Lunos

et al. 2016

Introduction: Pregnancy is a strong motivator to quit smoking, yet postpartum relapse rates are high. Growing evidence suggests a role of sex hormones in drug abuse behavior and given the precipitous drop in sex hormones at delivery, they may play a role in postpartum relapse. This pilot study evaluates the feasibility and potential role of exogenous progesterone in postpartum smoking relapse. Methods: This 12-week double-blind placebo-controlled randomized pilot trial randomized 46 abstinent postpartum women to active progesterone (PRO; 200 mg twice a day) versus placebo (PBO) for 4 weeks. Participants were followed for relapse for 12 weeks. Main study outcomes include abstinence (point prevalence), feasibility (compliance per number of clinic visits attended, pill counts and Electronic Data Capture [EDC] completed) and self-reported acceptability. Safety was also measured by depressive symptom scores, adverse events, and breastfeeding. Results: Overall retention rate was 87% at week 12. At week 4, abstinence rates were 75% in the PRO group and 68.2% in the PBO group (p = .75). Medication adherence was 68% and clinic visit attendance was 80%, with no differences by randomization. Depressive symptom scores, adverse events, and breastfeeding did not vary by randomization. Conclusions: Although the study was not powered to evaluate abstinence rates, we did observe a higher prevalence of abstinence at week 4 in the PRO group. Further, exogenous progesterone was well tolerated and did not adversely affect depressive symptoms or breastfeeding. Thus, the results of this pilot study indicate further investigation into progesterone as a postpartum relapse prevention strategy is warranted. Implications: This innovative pilot trial determined the feasibility of delivering exogenous progesterone as a potential prevention of postpartum smoking relapse. We observed high retention and moderate adherence rates, as well as high acceptability among participants. Further, though not statistically significant, more women in the treatment group remained abstinent from smoking during follow-up. This project adds to the growing body of literature on the role of sex hormones in smoking relapse and also provides support for a fully powered clinical trial.