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Clinical trials powered to detect subgroup effects provide the most reliable data on heterogeneity of treatment effect among different subpopulations. However, pre-specified subgroup analysis is not always practical and post hoc analysis results should be examined cautiously. Bayesian hierarchical modelling provides grounds for defining a controlled post hoc analysis plan that is developed after seeing outcome data for the population but before unblinding the outcome by subgroup. Using simulation based on the results from a tobacco cessation clinical trial conducted among the general population, we defined an analysis plan to assess treatment effect among American Indians and Alaska Natives (AI/AN) enrolled in the study. Patients were randomized into two arms using Bayesian adaptive design. For the opt-in arm, clinicians offered a cessation treatment plan after verifying that a patient was ready to quit. For the opt-out arm, clinicians provided all participants with free cessation medications and referred them to a Quitline. The study was powered to test a hypothesis of significantly higher quit rates for the opt-out arm at one-month post randomization. Overall, one-month abstinence rates were 15.9% and 21.5% (opt-in and opt-out arm, respectively). For AI/AN, one-month abstinence rates were 10.2% and 22.0% (opt-in and opt-out arm, respectively). The posterior probability that the abstinence rate in the treatment arm is higher is 0.96, indicating that AI/AN demonstrate response to treatment at almost the same probability as the whole population. [ABSTRACT FROM AUTHOR]

Bayesian adaptive designs with response adaptive randomization (RAR) have the potential to benefit more participants in a clinical trial. While there are many papers that describe RAR designs and results, there is a scarcity of works reporting the details of RAR implementation from a statistical point exclusively. In this paper, we introduce the statistical methodology and implementation of the trial Changing the Default (CTD). CTD is a single-center prospective RAR comparative effectiveness trial to compare opt-in to opt-out tobacco treatment approaches for hospitalized patients. The design assumed an uninformative prior, conservative initial allocation ratio, and a higher threshold for stopping for success to protect results from statistical bias. A particular emerging concern of RAR designs is the possibility that time trends will occur during the implementation of a trial. If there is a time trend and the analytic plan does not prespecify an appropriate model, this could lead to a biased trial. Adjustment for time trend was not pre-specified in CTD, but post hoc time-adjusted analysis showed no presence of influential drift. This trial was an example of a successful two-armed confirmatory trial with a Bayesian adaptive design using response adaptive randomization. [ABSTRACT FROM AUTHOR]

Stress and depressive symptoms have been linked to a reduced likelihood of sustaining smoking cessation. Because stress and depressive symptoms may negatively affect motivation to quit, stress and depression may also be important for whether or not smokers make a quit attempt. To examine the relationship between perceived stress and depressive symptoms and initiating a quit attempt in a smoking cessation induction trial. We conducted a secondary analysis of existing data from a randomized clinical trial (N = 255) comparing motivational interviewing to health education and brief advice for smoking cessation induction in smokers with low motivation to quit. We observed positive associations between baseline predictors and quit attempts at week 12 (r = 0.192, p < 0.01 for depressive symptoms and r = 0.136, p < 0.05 for perceived stress). Logistic regression models revealed similar significant positive associations between baseline perceived stress and baseline depressive symptoms and making a quit attempt by week 12 (OR = 1.5, CI:1.03, 2.19 and OR = 1.03, 95% CI: 1.01, 1.06; respectively). Unexpectedly, this study found generally small but consistently positive associations between baseline depressive symptoms and baseline perceived stress and making a quit attempt by week 12. The results can be viewed as encouraging in that interventions to encourage quit attempts do not appear counter-productive for individuals higher in stress and depressive symptoms, but these patients very likely will need additional supports to sustain abstinence. [ABSTRACT FROM AUTHOR]

Background:Research examining relationships between social support and smoking cessation has paid little attention to non-treatment seeking smokers and not considered the role of autonomy support for fostering quitting motivation. This study examined if autonomy support received from family and friends was associated with quitting motivation and making a quit attempt among diverse smokers with varying levels of quitting motivation. Demographic characteristics associated with autonomy support were explored. Methods:Participants (N = 312) responded to advertisements seeking smokers ‘not quite ready to quit,’ and were primarily Black, low-income and unemployed. Most (255) of them were enrolled in a clinical trial of smoking cessation induction strategies (treatment sample). An additional 57 not meeting the trial eligibility criteria of low quitting motivation were enrolled for baseline assessments only. Participants completed baseline measures of autonomy support received from friends and autonomous quitting motivation. In the treatment sample, quit attempts were assessed at six-month follow-up. Results:Females reported higher levels than males of autonomy support from friends (p = 0.003). Participants with a high school diploma/GED reported higher levels of support from family (p < 0.001) and friends (p = 0.014) than those with less education or a college/graduate degree. Both family (p = 0.007) and friends (p = 0.004) autonomy support scores were significantly, albeit weakly, associated with autonomous quitting motivation. Autonomy support was not associated with making a quit attempt. Conclusions:Support from family and friends may promote autonomous reasons to quit among diverse smokers. Research is needed to assess the role of social support in the pre-quitting phases among racial and socio-economically diverse populations. Clinical trial registration:ClinicalTrials.gov NCT01188018. [ABSTRACT FROM PUBLISHER]

Objective: We aimed to evaluate how psychiatric and personality disorders influence smoking cessation goals and attempts among people with opiate dependence who smoke. This information could aid the development of more effective cessation interventions for these individuals. Methods: Participants (N = 116) were recruited from two methadone clinics, completed the Millon Clinical Multiaxial Inventory-III, and were asked about their smoking behavior and quitting goals. We used the Least Absolute Shrinkage and Selection Operator (LASSO) method, a technique commonly used for studies with small sample sizes and large number of predictors, to develop models predicting having a smoking cessation goal, among those currently smoking daily, and ever making a quit attempt, among those who ever smoked. Results: Almost all participants reported ever smoking (n = 115, 99%); 70% (n = 80) had made a serious quit attempt in the past; 89% (n = 103) reported current daily smoking; and 59% (n = 61) had a goal of quitting smoking and staying off cigarettes. Almost all (n = 112, 97%) had clinically significant characteristics of a psychiatric or personality disorder. White race, anxiety, and a negativistic personality facet (expressively resentful) were negative predictors of having a cessation goal. Overall, narcissistic personality pattern and a dependent personality facet (interpersonally submissive) were positive predictors of having a cessation goal. Somatoform disorder, overall borderline personality pattern, and a depressive personality facet (cognitively fatalistic) were negative predictors of ever making a quit attempt. Individual histrionic (gregarious self-image), antisocial (acting out mechanism), paranoid (expressively defensive), and sadistic (pernicious representations) personality disorder facets were positive predictors of ever making a quit attempt. Each model provided good discrimination for having a smoking cessation goal or not (C-statistic of.76, 95% CI [0.66, 0.85]) and ever making a quit attempt or not (C-statistic of.79, 95% CI [0.70, 0.88]). Conclusions: Compared to existing treatments, smoking cessation treatments that can be tailored to address the individual needs of people with specific psychiatric disorders or personality disorder traits may better help those in opiate dependence treatment to set a cessation goal, attempt to quit, and eventually quit smoking. [ABSTRACT FROM AUTHOR]

Background: Over 80% of people in methadone treatment smoke cigarettes, and existing smoking cessation interventions have been minimally effective. Objective: To develop an Information-Motivation-Behavioral Skills (IMB) Model of behavior change based smoking cessation intervention for methadone maintained smokers, we examined smoking cessation related IMB factors in this population. Methods: Current or former smokers in methadone treatment ( n = 35) participated in focus groups. Ten methadone clinic counselors participated in an individual interview. A content analysis was conducted using deductive and inductive approaches. Results: Commonly known IMB factors related to smoking cessation were described. These factors included: the health effects of smoking and treatment options for quitting (information); pregnancy and cost of cigarettes (motivators); and coping with emotions, finding social support, and pharmacotherapy adherence (behavioral skills). IMB factors specific to methadone maintained smokers were also described. These factors included: the relationship between quitting smoking and drug relapse (information), the belief that smoking is the same as using drugs (motivator); and coping with methadone clinic culture and applying skills used to quit drugs to quitting smoking (behavioral skills). IMB strengths and deficits varied by individual. Conclusions: Methadone maintained smokers could benefit from research on an IMB Model based smoking cessation intervention that is individualized, addresses IMB factors common among all smokers, and also addresses IMB factors unique to this population. [ABSTRACT FROM AUTHOR]

Most substance abuse treatment facilities do not routinely treat cigarette smoking even though most of their clients smoke and many will die from tobacco-related illness. This study is a secondary analysis of a national survey of the prevalence and type of tobacco treatment services available in methadone maintenance treatment. It presents qualitative and quantitative information on provider attitudes regarding tobacco treatment in drug treatment. One clinic leader (either a medical director, head nurse, or clinic director) from all 697 U.S. facilities was invited to participate in the study. Most (38%) clinic leaders thought the best time to treat patients for nicotine dependence was whenever the patient wanted treatment. One in four clinic leaders reported they or one of their staff had advised patients to delay quitting smoking cigarettes. Fewer (14%) believed that patients in some way benefited from cigarette smoking; these benefits included managing mood disturbances (calming, reducing anxiety, depression, stress, anger) and substituting for illicit drug abuse. This suggests that some providers might rely on cigarettes in lieu of psychotherapy or prescription medications to address patients' mood disorders such as depression, anger, and anxiety. One tactic for disseminating tobacco treatment in drug treatment might involve identifying the purported benefits of tobacco and training providers in alternative methods for delivering these benefits. [ABSTRACT FROM AUTHOR]

This pilot study is the first to examine the feasibility and outcomes of dual pharmacotherapy for smoking cessation among drug treatment patients. The intervention consisted of 7 weeks of bupropion (300 mg), 12 weeks of nicotine gum, and 6 sessions of motivational interviewing. The trial was conducted among 28 patients recruited from 5 methadone clinics and employed a pretest-posttest design. At 6 months post quit date, 14% of participants met criteria for biochemically-verified abstinence. Among those still smoking, number of cigarettes smoked decreased significantly and most (88%) had made at least 1 serious quit attempt. Participation rates were excellent and no adverse effects on alchol or illicit drug use were found. Although not a definitive test of the intervention, findings suggest that a multi-component approach to tobacco dependence is feasible and potentially effective in helping drug treatment patients achieve smoking cessation well beyond the end of treatment and that a large-scale randomized trial is warranted. [ABSTRACT FROM AUTHOR]

Substance abuse among adolescents continues to drain communities in the United States in'terms of financial resources and human potential. Community coalitions or collaborative partnerships are a prominent strategy for preventing substance use and abuse since they engage multiple sectors of the community such as schools, churches, businesses, and law enforcement. Community coalitions serve as catalysts for change, attempting to change programs, policies, and practices in all relevant sectors. In this manuscript, we describe the multi-site replication of a nationally recognized substance abuse prevention coalition, Project Freedom. First, the original community coalition and the model upon which the replication initiative was designed are described. Second, the context and collaborators, replication sites, and technical assistance and evaluation components are described. Third, data on intermediate outcomeschanges in community programs, policies, and practices facilitated by one illustrative coalition are provided. Lastly, the key factors and challenges in supporting community-wide coalitions for the prevention of adolescent substance abuse are discussed. [ABSTRACT FROM PUBLISHER]