Complementing the Standard Multicomponent Treatment for Smokers With Denicotinized Cigarettes: A Randomized Trial.

INTRODUCTION: Standard treatments (STs) for smoking cessation typically combine pharmacotherapy and behavioral support but do not address the sensory and behavioral aspects of smoking which may play a role in maintaining smoking behavior. Replacing such sensations temporarily after cessation may enhance treatment efficacy. We hypothesized that denicotinized cigarettes (DNCs), which have a very low nicotine content but provide these sensory and behavioral stimuli, could help alleviate urges to smoke and tobacco withdrawal symptoms and in turn enhance the efficacy of ST. METHODS: Two hundred smokers seeking treatment received nine weekly behavioral support sessions and pharmacotherapy (100 used varenicline, 100 used nicotine replacement therapy). They were randomized on the target quit day to receive 280 DNCs (used ad libitum over 2 weeks in addition to ST) or ST alone. RESULTS: Urge-to-smoke frequency (2.61 vs. 2.96, P = .03) but not strength (2.85 vs. 3.10, P = .20) in the first week of abstinence was significantly lower in DNC users versus ST alone. There were no differences in composite withdrawal scores between groups. Abstinence was significantly higher among DNC users versus ST alone at 1 (OR = 2.07; 95% CI: 1.63% to 3.70%) and 4 weeks (OR = 1.83; 95% CI: 1.05% to 3.21%), but not at 12 weeks (OR = 1.42; 95% CI: 0.79% to 2.55%). DNC use was a significant predictor of abstinence at 1 and 4 weeks (OR = 2.63; 95% CI: 1.40% to 4.93% and OR = 2.38; 95% CI: 1.26% to 4.46%), but not at 12 weeks. CONCLUSIONS: Adding DNCs to ST has the potential to assist smokers early in their quit attempt, but research is needed to determine how best to utilize DNCs in treatment.

Increasing varenicline dose in smokers who do not respond to the standard dosage: a randomized clinical trial.

IMPORTANCE: Standard varenicline tartrate dosing was formulated to avoid adverse effects (primarily nausea), but some patients may be underdosed. To our knowledge, no evidence-based guidance exists for physicians considering increasing varenicline dose if there is no response to the standard dosage. OBJECTIVE: To determine whether increasing varenicline dose in patients showing no response to the standard dosage improves treatment efficacy. DESIGN, SETTING, AND PARTICIPANTS: In a double-blind randomized placebo-controlled trial, 503 smokers attending a stop smoking clinic commenced varenicline use 3 weeks before their target quit date (TQD). Two hundred participants reporting no strong nausea, no clear reduction in smoking enjoyment, and less than 50% reduction in their baseline smoking on day 12 received additional tablets of varenicline or placebo. INTERVENTIONS: All participants began standard varenicline tartrate dosing, gradually increasing to 2 mg/d. Dose increases of twice-daily varenicline (0.5 mg) or placebo took place on days 12, 15, and 18 (up to a maximum of 5 mg/d). MAIN OUTCOMES AND MEASURES: Participants rated their smoking enjoyment during the prequit period and withdrawal symptoms weekly for the first 4 weeks after the TQD. Continuous validated abstinence rates were assessed at 1, 4, and 12 weeks after the TQD. RESULTS: The dose increase reduced smoking enjoyment during the prequit period, with mean (SD) ratings of 1.7 (0.8) for varenicline vs 2.1 (0.7) for placebo (P = .001). It had no effect on the mean (SD) frequency of urges to smoke at 1 week after the TQD, their strength, or the severity of withdrawal symptoms: these ratings for varenicline vs placebo were 2.7 (1.1) vs 2.6 (0.9) (P = .90), 2.6 (1.1) vs 2.8 (1.0) (P = .36), and 1.5 (0.4) vs 1.6 (0.5) (P = .30), respectively. The dose increase also had no effect on smoking cessation rates for varenicline vs placebo at 1 week (37 [37.0%] vs 48 [48.0%], P = .14), 4 weeks (51 [51.0%] vs 59 [59.0%], P = .32), and 12 weeks (26 [26.0%] vs 23 [23.0%], P = .61) after the TQD. There was significantly more nausea (P < .001) and vomiting (P < .001) reported in the varenicline arm than in the placebo arm. CONCLUSIONS AND RELEVANCE: Increasing varenicline dose in smokers with low response to the drug had no significant effect on tobacco withdrawal symptoms or smoking cessation. Physicians often consider increasing the medication dose if there is no response to the standard dosage. This approach may not work with varenicline. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01206010.

Paul B. Beeson career development awards in aging research and U.S. medical schools aging and geriatric medicine programs.

Established in 1995, the Paul B. Beeson Career Development program provides faculty development awards to outstanding junior and midcareer faculty committed to academic careers in aging-related research, training, and practice. This study evaluated the effect of 134 Beeson Scholars on their medical schools' aging and geriatric medicine programs and on the field of aging research from 1995 to 2007. Quantitative and qualitative survey data from multiple sources, including the American Geriatrics Society/Association of Directors of Geriatric Academic Programs' Geriatrics Workforce Policy Studies Center, National Institutes of Health (NIH) rankings of research funding, and other governmental databases were used to compare 36 medical schools with Beeson Scholars with 34 similar medical schools without Beeson scholars and to examine the influence of Beeson Scholars on the field of geriatrics and aging. Most Beeson Scholars remained at the institution where they trained during their Beeson award, and 89% are still practicing or conducting research in the field of geriatrics and aging. Twenty-six (19.4%) of the scholars have led institutional research mentoring awards, 51 (39%) report leadership roles in institutional program project grants, and 13 (10%) report leadership roles in the Clinical and Translational Science Award programs at their institutions. Beeson Scholars are more likely than a matched sample of non-Beeson NIH K awardees to study important geriatric syndromes such as falls, cognitive impairment, adverse drug events, osteoporosis, and functional recovery from illness. Total Beeson Impact Years (the total number of years all Beeson Scholars have worked at each school) is positively correlated with more geriatrics research faculty, after controlling for NIH funding rank (P=.02). Beeson Scholars have made positive contributions to the development of academic geriatrics research programs at U.S. medical schools.