Mark A. Sembower

Relationship Between Adherence to Daily Nicotine Patch Use and Treatment Efficacy : Secondary Analysis of a 10-Week Randomized, Double-Blind, Placebo-Controlled Clinical Trial Simulating Over-the-Counter Use in Adult Smokers

BACKGROUND It has been reported that the efficacy of acute forms of nicotine replacement therapy, such as nicotine gum and lozenges, improves when sufficient quantities of medication are used. OBJECTIVE This analysis examined whether adherence with daily nicotine patch wear was associated with improved rates of smoking abstinence. METHODS This was a secondary analysis of data from a double-blind study in which subjects were randomized to receive either an active nicotine patch or a placebo patch under simulated over-the-counter conditions. Subjects were asked to complete a daily diary on their patch use and smoking. Logistic regression, controlling for smoking in the first 3 weeks of treatment, was used to evaluate the likelihood of abstinence at 6 weeks as a function of treatment assignment (active vs placebo) and adherence (ie, patch wear for >or=20 of the first 21 days of treatment). The relationship between reported adverse events and adherence was also examined. RESULTS This analysis involved data from 371 subjects, 204 using the active patch and 167 using the placebo patch. The study population was mainly white (87.3%), had a mean age of 42.8 years, a mean weight of 77.3 kg, had been smoking for a mean of 24.4 years, and smoked a mean of 25.2 cigarettes per day. Two hundred fifty-three subjects were classified as adherent. Rates of adherence did not differ significantly between the active and placebo groups (139 [68.1%] and 114 [68.3%], respectively). The likelihood of experiencing an adverse event did not differ significantly between adherent and nonadherent subjects in either group. Among active patch users, 61.5% of nonadherent subjects experienced an adverse event, compared with 59.7% of adherent subjects; among placebo patch users, the corresponding proportions were 41.5% and 43.9%. Among active patch users, the odds of abstinence at 6 weeks were more than 3 times greater for adherent versus nonadherent subjects (53.2% vs 21.5%, respectively; adjusted odds ratio [OR] = 3.25; 95% CI, 1.30-8.09; P = 0.011); no benefit of adherence over nonadherence was seen among users of the placebo patch (16.7% vs 15.1%; adjusted OR = 0.60; 95% CI, 0.16-2.31). The interaction between treatment group and adherence was statistically significant (P = 0.022). CONCLUSION Under conditions simulating over-the-counter use, adherence to daily nicotine patch wear within the first 3 weeks of treatment was associated with an improved likelihood of achieving smoking abstinence at 6 weeks.

Providing accurate safety information may increase a smoker's willingness to use nicotine replacement therapy as part of a quit attempt.

AIM Previous studies have reported that smokers who are misinformed about the safety of Nicotine Replacement Therapy (NRT) are less likely to report using it. In this study, we examined whether providing information that counters these concerns might impact on intentions to use NRT. PARTICIPANTS 900 smokers recruited from a market research database. DESIGN AND SETTING Participants completed an online survey that asked about their views about NRT. Smokers with safety and efficacy concerns were queried to determine whether accurate information might increase their interest in using NRT. FINDINGS Misperceptions of NRT safety were common: 93% of smokers did not know that smoking while wearing the nicotine patch does not cause heart attacks; 76% that nicotine gum/lozenge are not as addictive as cigarettes; and 69% that NRT products are not as dangerous as cigarettes. Over half of the smokers with misperceptions reported that they would be more likely to use NRT to help them quit smoking if they were exposed to information correcting their concerns (53%, 58% and 66%, respectively, for each of the misperceptions). CONCLUSIONS These data suggest that while a sizeable proportion of smokers are still misinformed about the safety of NRT, misinformed smokers would increase consideration of NRT if these misperceptions are addressed by corrective information.

Nonmedical Use of Prescription ADHD Stimulants and Preexisting Patterns of Drug Abuse

Multidrug use is well documented among nonmedical users of prescription stimulants. We sought to provide insight into the drug use patterns of those reporting nonmedical use of prescription attention-deficit hyperactivity disorder (ADHD) stimulants in an attempt to discern whether such use is a first step in a pattern of drug-abusing behavior or, conversely, is a later development accompanied or preceded by a history of drug abuse. A cross-sectional, population-based survey of the U.S. civilian, non-institutionalized population aged 12 years and older was analyzed for lifetime nonmedical use of prescription ADHD stimulants, lifetime nonmedical use of another prescription drug, illicit drug use, and drug use initiation patterns. This included 443,041 respondents from the 2002–2009 National Survey on Drug Use and Health. Lifetime nonmedical use of prescription ADHD stimulants was reported by 3.4% of those aged 12 years and older. Of these, 95.3% also reported use of an illicit drug (i.e., marijuana, cocaine/crack, heroin, hallucinogens, inhalants) or nonmedical use of another prescription drug (i.e., tranquilizers, pain relievers, or sedatives), and such use preceded nonmedical use of prescription ADHD stimulants in 77.6% of cases. On average, 2.40 drugs were used prior to the first nonmedical use of prescription ADHD stimulants. These data suggest that nonmedical use of prescription ADHD stimulants is not commonly an initiating factor leading to the nonmedical use of other prescription medications or abuse of illicit drugs. Rather, nonmedical use of prescription ADHD stimulants appears to be adopted by individuals already engaged in broader patterns of drug abuse and misuse.

Consumer Understanding of Prescription Drug Information: An Illustration Using an Antidepressant Medication

Background Patient education and warnings have emerged as prominent interventions for improving drug safety. As part of the provision of information and guidance on safe use of drugs, patients often receive multiple pieces of written information when they obtain a prescription medication, including a Food and Drug Administration (FDA)–mandated medication guide (MG), consumer medication information (CMI), and patient package insert (PPI). Objective: To determine whether patients understand the materials providing drug information and whether the materials convey the intended information. Methods: Fifty-two adults with a high school education or less were shown an actual (blinded) MG, CMI, and PPI for a marketed antidepressant medication. Comprehension was tested with methods used by the FDA to assess label comprehension for nonprescription products. Results: The majority of participants (88.2%) looked at all 3 pieces of information provided. The mean (SD) time spent reviewing the CMI was 5.2 (4.8) minutes (range 0-21.9). 16.5(13.3) minutes for the PPI (range 0-43.0), and 2.5 (1.6) minutes for the MG (range 0-7.6). Less than 20% of participants were able to identify the symptoms of a rare but potentially life-threatening situation that can occur with this medication and only 61.5% recalled the risk of teen suicide, which is the sole focus of the MG. Respondents with lower literacy scores performed more poorly than those with higher literacy scores. Conclusions: Information provided with at least some prescription drugs is not adequately understood by less-educated consumers and does not effectively communicate critical safety messages or directions.

Weight management advice: what do doctors recommend to their patients?

OBJECTIVE To examine the weight management interventions that a broad population of adults reported receiving from physicians and assess what drug-related and behavioral information physicians provided when they prescribe weight loss medications. METHODS A random-digit dialed telephone survey was conducted in 2005-2006 with a representative sample of 3,500 American adults. RESULTS The most frequently reported interventions were having a doctor tell them about the health problems associated with being overweight (48.0%), or suggesting diet and exercise (46.5%). Few respondents reported having been referred to a formal diet program (5.2%), prescribed a weight loss medication (4.0%), recommended a non-prescription weight loss product (1.8%), or recommended stomach bypass surgery (1.5%). The proportion of individuals who reported each intervention increased across levels of body mass index (p<0.001). Of those who reported being prescribed a weight loss medication (n=155), only 29.5% (n=44) reported receiving all six counseling interventions that were assessed. CONCLUSIONS Many overweight patients have not been advised to lose weight, diet, or exercise, and physicians have been particularly reluctant to recommend medications. When physicians do prescribe medications, appropriate counseling too often fails to accompany the prescription. Efforts are needed to increase the involvement of physicians in guiding patients to effective weight management approaches.

Surveillance of Diversion and Nonmedical Use of Extended-Release Prescription Amphetamine and Oral Methylphenidate in the United States

This article examines rates of nonmedical use and diversion of extended-release amphetamine and extended-release oral methylphenidate in the United States. Prescription dispensing data were sourced from retail pharmacies. Nonmedical use data were collected from the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System Drug Diversion Program and Poison Center Program. Drug diversion trends nearly overlapped for extended-release amphetamine and extended-release oral methylphenidate. Calls to poison centers were generally similar; however, calls regarding extended-release amphetamine trended slightly lower than those for extended-release oral methylphenidate. Data suggest similar diversion and poison center call rates for extended-release amphetamine and extended-release oral methylphenidate.

Prediction of abstinence at 10 weeks based on smoking status at 2 weeks during a quit attempt: Secondary analysis of two parallel, 10-week, randomized, double-blind, placebo-controlled clinical trials of 21-mg nicotine patch in adult smokers

BACKGROUND Smoking cessation outcomes are calculated as the probability of abstinence at follow-up among all enrolled smokers, but it is also useful to estimate the probability of success for those who experienced success or failure at earlier time points. OBJECTIVES The primary aims were to estimate the probability of maintaining abstinence through week 10 among subjects who were abstinent at week 2, and to assess the effect of active treatment with a nicotine patch. We also examined outcomes at week 6 and, among subjects who smoked during the first 2 weeks of treatment, the probability of reestablishing abstinence later, as well as the effect of active treatment on this outcome. METHODS We analyzed pooled data from 2 previously published, parallel, double-blind studies in which subjects were initially randomized to receive an active nicotine patch (starting at 21 mg) or a placebo patch. Subjects randomized to active treatment followed a double-blind step-down dosing regimen: 24-h/21-mg patches for the first 6 weeks of treatment, followed by 14- and 7-mg patches for successive 2-week periods. Biochemically verified abstinence (exhaled carbon monoxide <or=8 ppm) was assessed during laboratory visits. RESULTS Most subjects were white (94.8%) and female (61.6%), with a mean (SD) age of 43.1 (10.2) years. Subjects had been smoking for a mean of 24.5 (10.2) years and smoked a mean of 30.6 (10.4) cigarettes per day. In both the nicotine (n = 249) and placebo (n = 253) groups, all subjects who were abstinent during the first 2 weeks had a high probability of maintaining abstinence through week 10, but subjects treated with the active patch were significantly more likely to remain abstinent (active: 79.8% [67/84], placebo: 52.6% [20/38]; relative risk [RR] = 1.52 [95% CI, 1.10-2.09]). Also, at week 6, subjects receiving active treatment had a greater chance of remaining abstinent (active: 94.3% [82/87], placebo: 78.0% [32/41]; RR = 1.21 [95% CI, 1.02-1.43]). To assess the effect of treatment on recovery from smoking lapses, we examined the probability of abstinence during week 10 among subjects who smoked during the first 2 weeks of treatment. Among them, treatment was associated with a greater probability of later success: 31.4% (50/159) of those treated with the active patch and 12.5% (26/208) of those receiving placebo were abstinent at week 10 (RR = 2.52 [95% CI, 1.64-3.85]). Similar results were observed at week 6 (49.4% [80/162] vs 21.2% [45/212]; RR = 2.33 [95% CI, 1.72-3.15]). CONCLUSIONS More than two thirds (71.3%) of subjects who were abstinent 2 weeks into a quit attempt maintained that abstinence through the end of 10 weeks of treatment. Use of a nicotine patch was significantly associated with maintaining abstinence and with recovering abstinence after an early lapse.

Assigning dose of nicotine gum by time to first cigarette.

INTRODUCTION Nicotine gum, a proven effective aid to cessation, comes in two doses: 2-mg and 4-mg. Assignment to the higher dose has traditionally been based on daily cigarette consumption. This paper evaluates efficacy of the gum when the 4-mg dose is assigned based on time to first cigarette (TTFC) being ≤ 30 min. METHODS In a secondary analysis of a randomized, double-blind, placebo-controlled trial that allocated smokers randomly to placebo, 2-mg, or 4-mg gum (Garvey, A. J., Kinnunen, T., Nordstrom, B. L., Utman, C. H., Doherty, K., Rosner, B., et al. (2000). Effects of nicotine gum dose by level of nicotine dependence. Nicotine & Tobacco Research, 2, 53-63. doi:10.1080/14622200050011303), we evaluated outcomes when 4-mg gum was given to subjects with TTFC ≤ 30 (n = 158, placebo n = 159). RESULTS Active treatment doubled or tripled abstinence rates versus placebo. This also held among smokers with a history of treatment failure. The effect of 4-mg gum was significant among light smokers (<25 CPD) with TTFC ≤ 30; 2-mg gum was not. CONCLUSION This analysis suggests that assigning dose of nicotine gum based on TTFC is an effective and appropriate means of dose allocation.

Trends in serious quit attempts in the United States, 2009–14

Background and aims Quitting smoking is the most potent way to reduce the health risks associated with smoking cigarettes, and public health objectives in the United States include dramatic increases in the proportion of smokers making a serious quit attempt each year. The US Centers for Disease Control and Prevention (CDC) has, since 2000, set as its Healthy People 2020 objective to encourage 80% of smokers to make a serious quit attempt per year. This study assessed the trend in quit attempts from 2009 to 2014. Design We examined the percentage of US smokers making a serious quit attempt each year from 2009 to 2014 from the repeating cross‐sectional National Health Interview Survey (NHIS). Setting United States. Participants The number of qualifying respondents per year ranged from 5748 in 2010 to 7219 in 2012, with a total of 40 362 respondents included in the analysis. Measurements Respondents were deemed to have made a serious quit attempt if they were either current smokers who reported that they stopped smoking for more than 1 day in the past 12 months because they were trying to quit smoking, or reported being former smokers (smoked 100+ cigarettes life‐time, but now not smoking) who quit in the past year. Findings Analyses of trends from 2009 to 2014 showed an overall linear increase in quit attempts [odds ratio (OR) = 1.02, 95% confidence interval (CI) = 1.01–1.04, P = 0.0075], but also a quadratic trend (OR = 1.01, 95% CI = 1.00–1.02, P = 0.0189). Conclusions The proportion of US smokers making a serious quit attempt has increased since 2009, due to an upward trend since 2011. The 2014 serious quit attempt rate was 55.0%. These rates are still below the Healthy People 2020 objective of 80% of smokers making a serious quit attempt per year.

Testing of Candidate Icons to Identify Acetaminophen-Containing Medicines

Adding icons on labels of acetaminophen-containing medicines could help users identify the active ingredient and avoid concomitant use of multiple medicines containing acetaminophen. We evaluated five icons for communication effectiveness. Adults (n = 300) were randomized to view a prescription container label or over-the-counter labels with either one or two icons. Participants saw two icon candidates, and reported their interpretation; experts judged whether these reflected critical confusions that might cause harm. Participants rated how effectively each icon communicated key messages. Icons based on abbreviations of “acetaminophen” (“Ac”, “Ace”, “Acm”) were rated less confusing and more effective in communicating the active ingredient than icons based on “APAP” or an abstract symbol. Icons did not result in critical confusion when seen on a readable medicine label. Icon implementation on prescription labels was more effective at communicating the warning against concomitant use than implementation on over-the-counter (OTC) labels. Adding an icon to a second location on OTC labels did not consistently enhance this communication, but reduced rated effectiveness of acetaminophen ingredient communication among participants with limited health literacy. The abbreviation-based icons seem most suitable for labeling acetaminophen-containing medications to enable users to identify acetaminophen-containing products.