Ellen A. Dornelas

Nicotine Gum for Pregnant Smokers A Randomized Controlled Trial

OBJECTIVE: To estimate the safety and efficacy of treatment with 2-mg nicotine gum for smoking cessation during pregnancy. METHODS: Pregnant women who smoked daily received individualized behavioral counseling and random assignment to a 6-week treatment with 2-mg nicotine gum or placebo followed by a 6-week taper period. Women who did not quit smoking were instructed to reduce the number of cigarettes smoked by substituting with gum. Measures of tobacco exposure were obtained throughout the study. RESULTS: Participants in the nicotine (nequals;100) and placebo (nequals;94) groups were comparable in age, race/ethnicity, and smoking history. Biochemically validated smoking-cessation rates were not significantly higher with nicotine gum compared with placebo (after 6 weeks of treatment: 13% compared with 9.6%, P=.45; at 32–34 weeks of gestation: 18% compared with 14.9%, P=.56). Using a completer analysis, nicotine gum significantly reduced the number of cigarettes smoked per day (nicotine gum: −5.7 [standard deviation (SD)=6.0]; placebo: −3.5 [SD=5.7], P=.035), and cotinine concentration (nicotine gum: −249 ng/mL [SD=397]; placebo: −112 ng/mL [SD=333]; P=.04). Birth weights were significantly greater with nicotine gum compared with placebo (3,287 g [SD=566] and 2,950 g [SD=653], respectively, P<.001). Gestational age was also greater with nicotine-replacement therapy than with placebo (38.9 weeks [SD=1.7] and 38.0 weeks [SD=3.3], respectively; P=.014). CONCLUSION: Although nicotine gum did not increase quit rates, use of nicotine gum increased birth weight and gestational age, two key parameters in predicting neonatal wellbeing. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00115687 LEVEL OF EVIDENCE: I

Characteristics of people lost to attrition in psychiatric follow-up studies.

In a large (N = 1,744) study of previously hospitalized psychiatric patients, multiple follow-up attempts were made to contact the ex-patients over a 1-year period after their discharges. When contacted they were asked to provide information about their posthospital adjustment; 59.5% of the sample was reached at least once and usable data obtained either in a telephone interview or from a mailed survey form. The contacted and noncontacted people represented very different subpopulations, both demographically and in terms of typical psychiatric descriptors. Those who were of lower socioeconomic status, male, unmarried, racial minorities, and those with records of substance abuse or assaultiveness, and who were generally more severely impaired during the baseline hospitalization were underrepresented in the contacted group. Possible reasons for these sample biases, the implications for hospitals conducting outcome assessments (i.e., for research and program evaluation purposes), and strategies for dealing with this kind of methodological problem are discussed.

The DIET Study: Long-term Outcomes of a Cognitive-behavioral Weight-control Intervention in Independent-living Elders

OBJECTIVE To describe the long-term outcomes of a cognitive-behavioral weight-control intervention implemented in a community-based sample of independent-living, older adults. DESIGN A quasi-experimental design was used to compare an intervention community with a wait-listed control community. Comparisons between the communities were made at 40 weeks (J Am Diet Assoc. 1994;94:37-42). The controlled trial ended at 40 weeks; then both communities received 2 years of intervention. Two-year data from both communities were combined and are presented in this article. Three-year outcome data from the initial intervention community were available and are also presented. SUBJECTS A total of 247 overweight (> 4.5 kg of age-adjusted weight), older (mean age = 71 years) adults in 2 independent-living retirement communities participated in the study. INTERVENTION The Dietary Intervention: Evaluation of Technology (DIET) study consisted of an intensive 10-week psychoeducational approach focused on lifestyle change, followed by a less intensive 2-year phase focusing on relapse prevention and maintenance of lifestyle changes. OUTCOME MEASURES Physiologic and behavioral variables were analyzed at baseline and at 2 years after baseline. This article reports the combined 2-year outcome data from both retirement communities. Results of an additional follow-up 1 year after intervention was withdrawn are reported for the initial intervention community. STATISTICAL ANALYSIS A within-subjects repeated measures analysis of variance design was used to test for significant changes in weight and lipid values over time. RESULTS At 2 years, 70% of those who started the intervention remained actively enrolled. This group showed significant decreases in body mass index (-1.2, P < .001) and glucose level (-0.80 mmol/L, P < .001). Although high-density lipoprotein cholesterol (HDL-C) levels had increased at 40 weeks after baseline, this was not maintained at 2 years. At the 3-year follow-up, changes in body mass index and glucose level were maintained. APPLICATIONS/CONCLUSIONS The purpose of this article was to describe the long-term outcomes of a community-based weight-reduction intervention for older adults. The findings may be of interest to clinicians who design community or worksite weight-reduction programs. Although the intervention was designed to be a low-intensity program, attrition over the length of the study was still problematic. Nevertheless, our follow-up study indicates that this intervention was efficacious in maintaining reductions in weight and glucose levels for overweight older adults for 3 years.

Helping adolescents quit smoking:a needs assessment of current and former teen smokers.

This study compared the survey responses of 280 current and former adolescent smokers for what they perceived would be helpful (or what had helped) in quitting smoking. The survey was developed from focus groups and was structured using Prochaska and DiClementes Stages of Change health behavior framework. Results showd that former smokers and current smokers in the preparation stage of change shared beliefs about the importance of interpersonal support, those who were contemplating a quit decision worried about obstacles and internal issues, and current smokers not thinking about quitting focused on external rewards. The findings that significant differences exist based on the adolescent smokers Stage of Change imply that this framework can be appropriately applied to this context.

Differences in adolescent smoker and nonsmoker perceptions of strategies that would help an adolescent quit smoking

This study assessed adolescent smoker and nonsmoker perceptions of strategies that would help an adolescent smoker in his or her attempt to stop smoking. Surveys were distributed primarily in the schools at 4 geographic and ethnically diverse study sites. Respondents were 965 adolescents (49% female; 46% minority). Current smokers (n = 232) were asked to rate the extent to which they agreed or disagreed that supportive behaviors of friends and family, quitting strategies, or learning about quitting strategies would be helpful if they decided to quit. Nonsmokers (n = 733) were asked to indicate the degree to which they agreed or disagreed that these behaviors and strategies would be helpful if a friend decided to quit. Responses to each of the 33 attitude items were rated on a 5-point scale ranging from strongly disagree to strongly agree. Marked differences were observed between smokers and nonsmokers in the level of agreement on each item. In general, smokers reported far less enthusiasm for cessation strategies than nonsmokers. After adjusting for gender, age, and other covariates, smoking status was the strongest independent predictor of the number of items endorsed as agree or strongly agree. The results have implications for the design of peer-based and other interventions for adolescent smokers.

Predicting service utilization after psychiatric hospitalization

The purposes of this study were to determine (1) the extent of service utilization in the posthospitalization period and (2) the probability of specified service utilization outcomes for patients with given characteristics, using ordered logit models. The sample consisted of former inpatients who were evaluated for 6 months and responded to a mailed questionnaire or telephone interview at both the 3- and 6-month follow-up points. Significant independent predictors of service utilization at 6 months were the diagnosis, length of hospital stay, history of suicide attempts, perceived stress, and medication compliance at 3 months. High service utilization was evident in a sizable proportion of the sample and could be predicted using this model.

Genetic Vulnerability to Menthol Cigarette Preference in Women

BACKGROUND Smokers may prefer menthol cigarettes to mask the bitter taste of nicotine. Variation in the taste receptor gene, TAS2R38, may contribute to preference for menthol cigarettes. AIMS To determine whether two common haplotypes of TAS2R38 (proline-alanine-valine [PAV] and alanine-valine-isoleucine [AVI]), which have been associated, respectively, with bitter taste or a lack of bitter taste produced by propylthiouracil, are associated with preference for menthol cigarettes. METHODS Data on smoking and blood for DNA extraction and genotyping were obtained from 323 pregnant non-Hispanic or Hispanic Caucasian smokers. We genotyped three TAS2R38 single nucleotide polymorphisms (rs713598, rs1726866, and rs10246939) and constructed haplotypes. We examined associations between menthol preference and the frequency and distribution of the AVI and PAV haplotypes among study participants. RESULTS Participants smoked an average of 16 cigarettes per day before pregnancy. The PAV and AVI haplotype frequencies were 48% and 45%, respectively. Non-Hispanic women were less likely than Hispanic women to smoke menthol cigarettes. As hypothesized, the frequency of the PAV haplotype was greater in menthol than non-menthol smokers in both non-Hispanics (54% vs. 30%; χ(2) = 13.04, P < .001) and Hispanics (53% vs. 25%; χ(2) = 5.77, P = .016). This effect persisted after controlling for potential confounders in multivariate logistic regression. Menthol smokers had a greater number of PAV haplotypes/individual than non-menthol smokers [non-Hispanics odds ratio (OR) = 3.02 (1.56-5.85); P = .001; Hispanics OR = 3.60 (1.23-10.56); P = .020]. CONCLUSIONS These preliminary data support the hypothesis that a genetic propensity to experience heightened bitter taste perception increases the preference for menthol cigarettes.

Major depression and PTSD in pregnant smokers enrolled in nicotine gum treatment trial.

BACKGROUND AND OBJECTIVES Pregnant women face considerable barriers to smoking cessation. The purpose of this study was to determine the prevalence of major depressive disorder (MDD) and post-traumatic stress disorder (PTSD) and response to smoking cessation treatment in pregnant smokers participating in a randomized, placebo-controlled trial of nicotine gum. METHODS Participants were 194 low-income, ethnically diverse pregnant smokers. RESULTS Utilizing a structured interview, 45% and 18% of the subjects met criteria for a lifetime diagnosis of MDD and PTSD, respectively. There was no difference in response to treatment, based on the presence of either of these psychiatric disorders. CONCLUSIONS Cumulatively, these findings provide evidence of the high degree of unmet mental health needs in pregnant smokers. SCIENTIFIC SIGNIFICANCE Pregnant women with a history of MDD and PTSD appear to be as likely to benefit from smoking cessation treatment as those without such a history.

The impact of tetrahydrobiopterin administration on endothelial function before and after smoking cessation in chronic smokers.

Cardiovascular disease mortality is reduced following smoking cessation but the reversibility of specific atherogenic risk factors such as endothelial dysfunction is less established. We assessed brachial artery flow-mediated dilation (FMD) in 57 chronic smokers and 15 healthy controls, alone and after oral tetrahydrobiopterin (BH4) administration, to assess the extent to which reduced bioactivity of BH4, a cofactor for the endothelial nitric oxide synthase enzyme (eNOS), contributes to smoking-associated reductions in FMD. Thirty-four smokers then ceased cigarette and nicotine use for 1 week, after which FMD (±BH4 administration) was repeated. Brachial artery FMD was calculated as the peak dilatory response observed relative to baseline (%FMD). Endothelium-independent dilation was assessed by measuring the dilatory response to sublingual nitroglycerin (%NTG). Chronic smokers exhibited reduced %FMD relative to controls: (5.6±3.0% vs. 8.1±3.7%; P<0.01) and %NTG was not different between groups (P=0.22). BH4 administration improved FMD in both groups (P=0.03) independent of smoking status (P=0.78) such that FMD was still lower in smokers relative to controls (6.6±3.3% vs. 9.8±3.2%; P<0.01). With smoking cessation, FMD increased significantly (from 5.0±2.9 to 7.8±3.2%;P<0.01); %NTG was not different (P=0.57) and BH4 administration did not further improve FMD (P=0.33). These findings suggest that the blunted FMD observed in chronic smokers, likely due at least in part to reduced BH4 bioactivity and eNOS uncoupling, can be restored with smoking cessation. Post-cessation BH4 administration does not further improve endothelial function in chronic smokers, unlike the effect observed in nonsmokers, indicating a longer-term impact of chronic smoking on vascular function that is not acutely reversible.

Determinants and Barriers to Participation in an Internet Based Recovery Program for Cardiac Patients

Patients hospitalized for coronary heart disease were offered a home recovery program utilizing the Internet. About one-half of the patients interviewed chose to enlist in this program. Participants and non-participants did not differ significantly according to medical risk and diagnostic factors, lifestyle and some demographic variables (principally marital status, sex, and race). However, those who owned personal computers and/or were familiar with the Internet, who were in higher socioeconomic strata, and were younger than age 65 were strongly more likely to participate. Internet instruction and computers (for those who had none) were provided to participants. Those who were lent computers—29% of the program participants—were more often female, without any college training, and less confident about using the Internet. As the public becomes increasingly more familiar with personal computer technology these potential barriers to its use may eventually disappear. The present study evaluated a fairly resolute method to introduce an Internet program to many recovering patients who were unfamiliar with this technology. However, other innovative and perhaps more aggressive ways of making those most in need of such valuable health-related information and resources can be tested in the near future.