Sarah S. Dermody

Randomized Trial of Reduced-Nicotine Standards for Cigarettes

BACKGROUND The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes. METHODS We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6. RESULTS A total of 840 participants underwent randomization, and 780 completed the 6-week study. During week 6, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes, respectively) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram (22.2 and 21.3 cigarettes, respectively; P<0.001). Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day, which did not differ significantly from the average number among those who smoked control cigarettes. Cigarettes with lower nicotine content, as compared with control cigarettes, reduced exposure to and dependence on nicotine, as well as craving during abstinence from smoking, without significantly increasing the expired carbon monoxide level or total puff volume, suggesting minimal compensation. Adverse events were generally mild and similar among groups. CONCLUSIONS In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products; ClinicalTrials.gov number, NCT01681875.).

An Evaluation of the Stress-Negative Affect Model in Explaining Alcohol Use: The Role of Components of Negative Affect and Coping Style

The stress-negative affect model for alcohol use was examined. The mediating roles of different components of negative affect were tested in the context of coping style. Data from 1,057 drinking adults (Mage = 44.45) and 352 drinking college students (Mage = 19.07) collected during 2001–2005 and in 2010, respectively, were examined separately. Participants completed self-administered measures of alcohol use, coping strategies, negative life events, and negative affect. A structural equation modeling framework detected stress-related drinking only in the adult sample. Sadness, anger, and guilt were significant mediators and the significant pathways differed based on coping style. The implications and limitations of the study are discussed.

Sex differences in response to reduced nicotine content cigarettes

BACKGROUND When switching from usual brand cigarettes, very low nicotine content (VLNC) cigarettes lead to a reduction in the number of cigarettes smoked, toxicant exposure, withdrawal symptoms and dependence. One area that has been relatively unexplored is what factors might moderate the effects of VLNC cigarettes. This exploratory analysis focuses on sex differences in responses to VLNC cigarettes and nicotine replacement therapy. METHODS An exploratory secondary analysis of a randomized trial of 235 participants (58% female, mean age 47 years) comparing a) 0.05-0.09 mg nicotine yield cigarettes; b) 21 mg nicotine patch and 3) 0.05-0.09 nicotine yield cigarettes with 21 mg nicotine patch was conducted. We focused on sex differences in product use, and impact of products on withdrawal response from usual brand cigarettes and abstinence by randomized group. RESULTS The combination of VLNC cigarettes and nicotine patch was more effective in reducing use of VLNC cigarettes and withdrawal symptoms among males than females, whereas females were equally responsive to VLNC cigarettes with and without the nicotine patch. Females were more likely to quit smoking than males when assigned to either of the conditions that incorporated the VLNC cigarettes; however, males were more likely to quit smoking in the nicotine patch alone condition than females. CONCLUSION Sex of the smoker may be an important determinant for effects of VLNC cigarettes and nicotine patch. Future large randomized trials to confirm these results are needed.

Mental health and substance use disparities among urban adolescent lesbian and bisexual girls.

BACKGROUND: Sexual minority girls (SMGs) report large substance use disparities and victimization experiences, yet there is a dearth of research that focuses exclusively on SMGs. OBJECTIVE: To examine substance use and mental health disparities among SMGs and to determine whether disparities were larger for African American compared with European American girls. METHOD: Data were used from Wave 11 of the Pittsburgh Girls Study, a multiple-cohort, prospective study of urban girls. Girls for the current analysis were aged 16 to 19 years. Fifty-five percent were African American. One hundred and seventy-three (8.3%) identified as SMGs, and 1,891 identified as heterosexual. Multiple regression analyses controlling for age, race, and parent education were conducted. RESULTS: SMGs reported a robust pattern of large disparities in externalizing, internalizing, and borderline personality disorder symptoms. There was little evidence to suggest disparities were moderated by race. CONCLUSION: SMGs and their families would benefit from intervention and prevention programs to reduce disparities among this highly vulnerable population.

Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation

Objective Reducing the nicotine content of cigarettes is a potential regulatory strategy that may enable cessation. The present study investigated the effect of nicotine exposure while smoking very low nicotine content (VLNC) cigarettes on cessation outcomes. The roles of possible sources of nicotine were also explored, including the VLNC cigarette and co-use of cigarettes with normal nicotine content. Methods A secondary data analysis of two analogous randomised trials of treatment seeking, adult daily smokers (n=112) who were instructed to smoke VLNC cigarettes for 6 weeks and then make a quit attempt. Controlling for baseline demographic and smoking features, the association between reductions in nicotine exposure during the 6-week trial, assessed by urinary total cotinine and biomarker-confirmed smoking abstinence 1 month later, was tested. Subsequent analyses controlled for the effects of the frequency of VLNC and normal nicotine content cigarette use and the nicotine yield of the VLNC cigarette (0.05 vs 0.09 mg). Results Greater reductions in nicotine exposure while smoking VLNC cigarettes predicted abstinence independent of individual differences in baseline smoking, cotinine, dependence, gender and study. Nicotine reduction was largest among individuals who were assigned to smoke a VLNC cigarette with lower nicotine yield and who smoked fewer normal nicotine content and VLNC cigarettes. Conclusions In the context of nicotine regulations and corresponding research, factors that undermine nicotine reduction must be addressed, including the availability and use of cigarettes with normal nicotine content and not sufficiently reducing the nicotine yield of cigarettes. Maximising nicotine reduction may facilitate smoking cessation. Trial registration numbers NCT 101050569 and NCT 00777569.

The predicted impact of reducing the nicotine content in cigarettes on alcohol use.

INTRODUCTION Product standards reducing the level of nicotine in cigarettes could significantly improve public health by reducing smoking behavior and toxicant exposure. However, relatively little is known about how the regulatory strategy could impact alcohol use, a closely related health behavior that is also a major contributor to morbidity and mortality. The primary objective of this paper is to predict the effect of nicotine reduction on alcohol use, identify priorities for future research, and highlight areas for mitigating any adverse outcomes. METHODS We critically reviewed and integrated literatures examining the effects of very low nicotine content (VLNC) cigarettes on smoking-related outcomes (nicotine exposure, nicotine withdrawal, and smoking as a cue to drink) and, in turn, the effects of those outcomes on alcohol use. RESULTS Current evidence suggests reducing the nicotine content of cigarettes may benefit public health by reducing alcohol use and problematic drinking over time as a consequence of reduced exposure to nicotine and the smoking cues associated with drinking. Nicotine withdrawal could increase risk of drinking, although these effects should be short-lived and could be mitigated by other sources of nicotine. Gender, hazardous drinking, and psychiatric comorbidities are likely to be important moderators of the effects of VLNC cigarettes. CONCLUSIONS It is imperative to broadly assess the public health impact of potential tobacco product regulations by including measures of closely related health behaviors that could be impacted by these interventions. Nicotine reduction in cigarettes may contribute to improved public health through reductions in alcohol use.

A Critical Review of the Effects of Nicotine and Alcohol Coadministration in Human Laboratory Studies

Simultaneous use of cigarettes and alcohol is common and may be driven by nicotine increasing alcohol self-administration or vice versa. To better evaluate the causal nature of this relationship, we systematically reviewed human experimental laboratory studies that coadministered nicotine and alcohol with control conditions. Searches of PubMed/MEDLINE and PsycINFO databases and study bibliographies identified 30 studies that met our inclusion criteria. Research methodologies were critically reviewed. Effects of coadministration on drug self-administration and related factors such as craving, subjective response, motivation, and heart rate are reported. Results most strongly supported that alcohol increases nicotine and cigarette self-administration, whereas, depending on the context, nicotine increased, decreased, or had no effect on alcohol self-administration. Craving and subjective drug effects were also impacted by coadministration. Interaction effects of nicotine and alcohol on self-administration and subjective responses were reported infrequently. The effects may be moderated by a number of factors, including dose of administered drug and sex. Recommendations are made for future research, and clinical and policy implications of findings are discussed.

Modeling the complexity of dynamic, momentary interpersonal behavior: Applying the time-varying effect model to test predictions from interpersonal theory

This paper demonstrates a recently-popularized quantitative method, the time-varying effect model (TVEM), in describing dynamic, momentary interpersonal processes implicated by Interpersonal Theory. We investigated moment-to-moment complementarity in affiliation and control behaviors (i.e., correspondence in affiliation and reciprocity in control between married dyad members) in a five-minute interaction (N=135), and how complementarity changed over time. Overall, results supported complementarity in affiliation and control. Moreover, effects were time-varying: Complementarity in affiliation increased over time and complementary in control changed over time in a cyclical manner. Dyadic adjustment moderated the strength in complementarity in control during specific timeframes. We discuss implications of these results and future directions. The findings support the utility of TVEM for studying dynamic and time-dependent interpersonal processes.

Becoming tobacco-free: Changes in staff and patient attitudes and incident reports in a large academic mental health and addictions hospital

BACKGROUND AND OBJECTIVE Complete tobacco bans in mental health facilities are thought to have the potential for adverse consequences. We evaluated staff and patient attitudes and adverse events associated with implementing Canadas largest, multi-site academic psychiatric hospital tobacco ban. METHODS A total of 1,173 staff and 422 patients completed an anonymous attitudes survey at prior to implementation (baseline), and 4-6 months and 10-12 months post-implementation. The tobacco-free initiative was implemented in a phased approach, allowing the prospective measurement of changes in attitudes and adverse outcomes such as agitation over a 1-year period. RESULTS We observed positive changes in staff and patient attitudes toward the tobacco-free policy for both staff and patients. Moreover, there was also a statistically significant decrease in patient agitation F (2, 99) = 3.25, p = .04, but no change F (2, 21) = 1.09, p = .35 in fire-related incidents. DISCUSSION AND CONCLUSIONS We observed positive changes in staff and patients attitudes and significant decrease in patient agitation during the first year of this tobacco-free hospital initiative. SCIENTIFIC SIGNIFICANCE During the first year of this tobacco-free psychiatric hospital policy, implementation of a tobacco-free environment in a large mental health and addictions setting was feasible and perceived as desirable by the majority of staff and patients surveyed and a decrease in incidents related to patient agitation was also observed. Further well-controlled studies with longer study durations are warranted. (Am J Addict 2017;26:183-191).

A study of alcohol use by designated drivers among college students.

Abstract Objective: College students tend to drink while serving as a designated driver (DD). The predictors of alcohol use by DDs among college students were examined. Participants: Participants were 119 undergraduate students in introductory psychology courses who had experience with DD use. Methods: Survey data were analyzed to examine the predictors of planning components of DD use, such as choosing a DD before drinking and choosing an abstinent DD, and the relations of these components to alcohol use by DDs. Results: History of DD use, friends’ willingness to be the DD, frequency of riding with a driver who drank and drove, and age of drinking onset were associated with planning components of DD use. Among the planning components of DD use, choosing a DD before drinking was significantly related to less alcohol use by DDs. Conclusions: Increasing awareness of the planning components of DD use could deter alcohol use by DDs among college students.