Introduction

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This study assessed the relationship between beliefs about drug assignment and abstinence status in two treatment studies using nortriptyline hydrochloride as an adjunct to smoking cessation. Smokers (N = 345) drawn from two clinical trials were asked at the final follow-up (FFU) at 52 or 64 weeks whether they believed they had received active or placebo drug. Responses were obtained from 262 participants, or 76% of the sample. Biochemically verified abstinence was collected at end of treatment (EOT) and FFU. In both studies, participants were correct in guessing drug assignment. At FFU, belief about drug assignment was not related to abstinence for either active or placebo participants. Participants who received active drug and who were smoking at EOT were more likely to believe they had received placebo than active drug participants who were abstinent at EOT. We found no significant relationship between belief about drug and abstinence status for placebo participants at EOT. Baseline variables did not significantly predict correctness of drug identification. Participants who experienced drug side-effects not easily attributable to nicotine withdrawal were more likely to identify their drug assignment as nortriptyline. We conclude that experience during the active treatment period, including side-effects and treatment success, may be related to belief about drug assignment, that the field would be well served by at least two assessments of blindness in clinical trials, and that discrepancy between these findings and those regarding nicotine replacement therapy may be related to differences in dependent variables.

Objective

Method

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Sustained-release bupropion and nortriptyline have been shown to be efficacious in treating cigarette smoking. Psychological intervention is also recognized as efficacious. The cost and cost-effectiveness of the 2 drug therapies have not been estimated. It was hypothesized that nortriptyline would be more cost-effective than bupropion. Hypotheses were not originally proposed concerning the cost-effectiveness of psychological versus drug treatment, but the 2 were compared using exploratory analyses. This was a 3 (bupropion versus nortriptyline versus placebo) by 2 (medical management alone versus medical management plus psychological intervention) randomized trial. Participants were 220 cigarette smokers. Outcome measures were cost and cost-effectiveness computed at week 52. Nortriptyline cost less than bupropion. Nortriptyline was more cost-effective than bupropion; the difference was not statistically significant. Psychological intervention cost less than the 2 drug treatments, and was more cost-effective, but not significantly so. Prospective investigations of the cost and cost-effectiveness of psychological and pharmacological intervention, using adequate sample sizes, are warranted.

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The relationship between major depressive disorder (MDD), treatment modality, and mood was evaluated in smokers participating in cessation programs. Participants (N = 549, 53.7% women, 46.3% men, 28% endorsing past MDD episodes) were randomly assigned to a cognitive-behavioral treatment (CBT) or health education (HE) intervention. Participants with a history of recurrent MDD (MDD-R) had higher rates of abstinence in CBT compared with HE even when the contribution of mood and the interaction between mood and an MDD x Treatment variable were included in the model. Likewise, higher levels of mood disturbance were reported by MDD-R smokers compared with those reporting a single episode. The study replicated results reported by R. A. Brown et al. (2001) and expanded upon them by evaluating the differential contribution of poor mood on cessation outcomes relative to MDD history.

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Sexual and gender minority (SGM) young adults have higher smoking prevalence than their non-SGM peers. Less is known about differences in smoking characteristics within the SGM community.

Participants were SGM young adult smokers age 18-25 (N = 165, M age = 21.8) enrolled in a clinical trial of the Put It Out Project, a Facebook smoking cessation intervention for SGM young adults. Analyses tested differences between 1) sexual orientation groups, and 2) gender identity groups, on the following smoking characteristics: cigarettes/day, daily smoker (yes/no), social smoker (yes/no), years of smoking, number of close friends who smoke (out of 5), age of initiation, age began smoking regularly, time to first cigarette (30 min or less/>30 min), lifetime quit attempts, past-year quit attempts, and stage of change for quitting smoking (precontemplation, contemplation, preparation).

Participants were 56% bi/pansexual, 18% gay, 18% lesbian, 8% other (e.g., asexual, queer). The gender identity of the sample was 52% cisgender, 18% transgender, 30% gender non-binary. Lesbian women began smoking at an older age (M = 18.0, SD = 2.0) than "other" sexual orientation participants (M = 15.7, SD = 2.2), p < .05. Transgender participants smoked the most cigarettes per day (M = 11.3, SD = 6.7), followed by cisgender (M = 8.1, SD = 5.6), then non-binary (M = 5.7, SD = 3.5) participants (p < .001; pairwise comparisons p's < 0.05). No other constructs differed by sexual orientation or gender.

Smoking characteristics were mostly similar across subgroups of young adult SGM smokers; however, transgender individuals were heavier smokers.

AIM: To compare the concurrent and predictive validities of two subsets of DSM-IV criteria for nicotine dependence (tolerance and withdrawal; withdrawal; difficulty controlling use; and use despite harm) to the concurrent and predictive validity of the full DSM-IV criteria. DESIGN: Analysis of baseline and outcome data from three randomized clinical trials of cigarette smoking treatment. SETTING: San Francisco, California. PARTICIPANTS: Two samples of cigarette smokers (n = 810 and 322), differing with regard to baseline characteristics and treatment received, derived from three randomized clinical trials. MEASUREMENTS: DSM-IV nicotine dependence criteria were measured at baseline with a computerized version of the Diagnostic Interview Schedule for DSM-IV (DIS-IV). Additional baseline measures included the Fagerström Test of Nicotine Dependence (FTND), number of cigarettes smoked per day, breath carbon monoxide (CO) level, the Minnesota Nicotine Withdrawal Scale (MNWS), the Michigan Nicotine Reinforcement Questionnaire (M-NRQ) and the Profile of Mood States (POMS). Seven-day point-prevalence abstinence was assessed at week 12. FINDINGS: Full DSM-IV criteria displayed greater concurrent validity than either of the two subsets of criteria. However, DSM-IV symptoms accounted for only a nominal amount of the variance in baseline smoking-related characteristics and were unrelated to smoking abstinence at week 12. Cigarettes smoked per day was the only significant predictor of abstinence at week 12. CONCLUSIONS: Although the findings do not provide a compelling alternative to the full set of DSM-IV nicotine dependence criteria, its poor psychometric properties and low predictive power limit its clinical and research utility.