Randomised trial of two nicotine patch protocols distributed through a state quitline.

BACKGROUND: Most telephone quitlines provide free nicotine replacement therapy (NRT). An 8-week course is recommended, but few users complete it. Information is needed to help quitlines distribute NRT cost-effectively. DESIGN: Randomised two-group trial. SETTING/PARTICIPANTS: Colorado QuitLine callers who smoked 16-20 cigarettes per day at enrolment and who were eligible for and agreed to receive free NRT. INTERVENTION: Provision of 4-week versus 8-week NRT supply; the 8-week supply was shipped in halves and required participants to request the second half (split-shipment protocol). Enrolment occurred during March 2010-February 2011, follow-up concluded in November 2011, and analysis was performed in 2012. MAIN OUTCOME MEASURES: Point abstinence (7 and 30 day) and prolonged abstinence (6 month) from tobacco use. RESULTS: Overall, 1495 study participants were enrolled and 57.7% completed follow-up. Abstinence rates did not differ significantly between study conditions: 13.8% versus 12.4% in 4-week versus 8-week arms, respectively, (30-day point abstinence, non-respondents treated as smokers). NRT duration was similar in both groups, due in part to purchase of additional patches in the 4-week group. About one-third of the 8-week group requested the full 8-week supply and had higher abstinence rates. Cost per quit was lower in the 4-week (compared to 8-week) group. CONCLUSIONS: A randomised trial did not find worse cessation outcomes among quitline users who received half the minimum recommended course of NRT, but offering the full recommended course using a split-shipment protocol may be reasonably cost-effective and supportive of NRT adherers. TRIAL REGISTRATION NUMBER: NCT01889771.

Community-based navigators for tobacco cessation treatment: a proof-of-concept pilot study among low-income smokers.

BACKGROUND: A majority of continuing smokers in the United States are socioeconomically disadvantaged (SED) adults, who are less likely than others to achieve and maintain abstinence despite comparable quit-attempt rates. A national research initiative seeks effective new strategies for increasing successful smoking cessation outcomes among SED populations. There is evidence that chronic and acute stressors may interfere with SED smokers who try to quit on their own. Patient navigators have been effectively used to improve adherence to chronic disease treatment. We designed and have pilot-tested an innovative, non-clinical community-based intervention--smoking cessation treatment navigators--to determine feasibility (acceptance, adherence, and uncontrolled results) for evaluation by randomized controlled trial (RCT). METHODS: The intervention was developed for smokers among parents and other household members of inner city pre-school for low-income children. Smoking cessation treatment navigators were trained and deployed to help participants choose and adhere to evidence-based cessation treatment (EBCT). Navigators provided empathy, resource-linking, problem-solving, and motivational reinforcement. Measures included rates of study follow-up completion, EBCT utilization, navigation participation, perceived intervention quality, 7-day point abstinence and longest abstinence at three months. Both complete-case and intent-to-treat analyses were performed. RESULTS: Eighty-five percent of study participants (n = 40) completed final data collection. More than half (53%) enrolled in a telephone quitline and nearly three-fourths (71%) initiated nicotine replacement therapy. Participants completed a mean 3.4 navigation sessions (mean 30 min duration) and gave the intervention very high quality and satisfaction ratings. Self-reported abstinence was comparable to rates for evidence-based cessation strategies (21% among study completers, 18% using intent-to-treat analysis; median 21 days abstinent among relapsers). CONCLUSIONS: The pilot results suggest that smoking cessation treatment navigators are feasible to study in community settings and are well-accepted for increasing use of EBCT among low-income smokers. Randomized controlled trial for efficacy is warranted.

Medicinal nicotine nonuse: smokers' rationales for past behavior and intentions to try medicinal nicotine in a future quit attempt.

INTRODUCTION: Nicotine replacement therapy (NRT) is a proven smoking cessation treatment. Previous research has reported low rates of NRT use among quit attempters. This study analyzed population-level nonuse rates and reasons for not using NRT. METHODS: Data were from the 2008 adult Colorado Tobacco Attitudes and Behaviors Survey (TABS), a population-based, random-digit-dialed telephone survey (n = 14,156). Primary measures were past NRT nonuse and future intentions regarding NRT use among current smokers intending to quit. Multiple logistic regression was used to identify reasons for past NRT nonuse associated with intention to use NRT in the future, adjusted for factors known to influence NRT use. RESULTS: Nearly, 80% of 1,095 current smokers who intended to quit had never used NRT. The most common reasons for nonuse were belief that "willpower" alone is sufficient for cessation (21.5%), perceived lack of NRT effectiveness (15.6%), and cost (14.3%). Willpower was more widely reported among Hispanics than Anglos (36.9% vs. 14.7%) and nondaily versus daily smokers (30.4% vs. 12.5%). Most previous NRT nonusers reported they would use cold turkey (65.2%) in their next quit attempt; NRT was the next most common choice (15.0%). In multivariate analysis, smokers identifying cost or willpower as a reason for previous nonuse had significantly lower odds of planning to use NRT in a future quit attempt. CONCLUSIONS: The majority of smokers have never used NRT and do not plan to use it in the future. Cost and belief in willpower alone are significant barriers to using NRT in future smoking cessation attempt.

Do You Know How to Assess Risks Posed by Over-the-Counter Vitamin A Supplements?

Dietary supplements are regulated as foods by the US Food and Drug Administration (FDA) and, despite their potentially harmful effects, are not subject to labeling rules that apply to prescription medications. This commentary responds to a case about vitamin A supplement safety. The commentary compares regulation of vitamin A-derivative prescription medications, such as isotretinoin, to regulation of high-dose vitamin A supplements, illuminating both products' potential for causing birth defects. Label analysis is key to educating patients about risks of vitamin A-containing supplements. The commentary also suggests the need for more FDA oversight of the dietary supplement industry.

Risk of Birth Defects From Vitamin A "Acne Supplements" Sold Online.

BACKGROUND: Dietary supplements are popular among US consumers and claim to address a variety of conditions, including acne. Acne supplements containing vitamin A are of particular interest, due to the potentially teratogenic effects of vitamin A doses over 10,000 IU. OBJECTIVE: This study examined dosage, pregnancy risks, and labeling of vitamin A-containing acne supplements available online. METHODS: An Internet search of acne supplements sold online was conducted between March and May 2020. Supplement labels and websites were analyzed for vitamin A content and pregnancy warnings, and then divided into categories based on dosage and teratogenic risk. RESULTS: A total of 49 acne supplements was found, and of these 26 (53%) contain vitamin A. Three supplements are likely teratogenic, 4 contain vitamin A doses exceeding the daily level of intake that meets the nutritional needs of most people, and 15 have an unknown teratogenic risk. Among the 6 supplements with over 10,000 IU vitamin A, 2 have no pregnancy warning at all, including the supplement with the highest vitamin A dose found in this study. CONCLUSIONS: Dietary supplements are not subject to the same stringent regulations as drugs, and as such, consumers may be unaware of pregnancy risks. Furthermore, FDA requirements on labeling of vitamin A supplements may lead to consumer confusion regarding dosage. As such, we encourage stricter labeling requirements for vitamin A-containing supplements, including pregnancy warnings for high-dose supplements and clearer dosage labeling.

Reaching Spanish-speaking smokers: state-level evidence of untapped potential for QuitLine utilization.

OBJECTIVES: We examined the effects of a Spanish-language media campaign on the reach and outcomes of a state-sponsored QuitLine among Latino smokers. METHODS: In this quasiexperimental (2-group, pre-post) study, we analyzed data from Colorado QuitLine callers before (April-August 2007) and during (September-November 2007) the media campaign. Call volume, service utilization, and quit rates at 7-month follow-up were compared between Latino (n = 243) and non-Latino (n = 527) callers. RESULTS: QuitLine calls increased among Latinos during the campaign by 57.6% (1169 vs 1842 in 3-month periods). Compared with precampaign Latino study respondents, Latino respondents during the campaign were significantly younger (younger than 45 years), more often Spanish speaking, uninsured, and less educated. Among Latino enrollees, program completion and nicotine replacement therapy use were similar before and during the campaign, and quit rates during the campaign improved marginally to significantly (7-day abstinence: 29.6% vs 41.0%, P = .07; 6-month abstinence: 9.6% vs 18.8%, P = .04). CONCLUSIONS: A well-designed, statewide Spanish-language media campaign increased QuitLine reach and improved cessation outcomes among a young Latino population of low socioeconomic status. QuitLine-supported cessation can be increased among these smokers.

Reduced NRT supplies through a quitline: smoking cessation differences.

INTRODUCTION: Quitlines (QLs) provide effective smoking cessation treatment. The most cost-effective protocol for nicotine replacement therapy (NRT) has not been established. The current study compares self-reported 7-day abstinence rates among light to moderate smokers (< or = 20 cigarettes per day [CPD]) when a state QL reduced NRT supplies from 8 to 4 weeks. METHODS: The study (n = 1,710) included Colorado QuitLine enrollees who requested free NRT. Analysis compared light to moderate smokers when 8- versus 4-week NRT supplies were available; the nonequivalent control group was heavy smokers (>20 CPD), who were consistently eligible for 8 weeks of NRT during the same time period. RESULTS: Under the reduced NRT protocol, abstinence declined by nearly one fourth among light to moderate smokers (29.9% vs. 39.3%, p < .01). Heavy smokers reported no difference in abstinence rates (28.6% vs. 28.4%, p = nonsignificant). DISCUSSION: Reducing NRT supplies from 8 to 4 weeks was associated with a one-fourth reduction in smoking abstinence rates among users of a state telephone QL. Future research should experimentally assess cost-effectiveness of 4- versus 8-week NRT protocols in QLs and should examine potentially mediating or moderating factors, such as history-affected expectancies regarding NRT and smoking cessation.

Risks of Skin, Hair, and Nail Supplements.

Skin, hair, and nail supplements, sometimes referred to as "beauty supplements" or "ingestible skin care," are a large and growing industry. These products may contain vitamins and minerals, sometimes in very high doses. They may also contain herbs, hormones, microbes, or animal derivatives such as fish oils and collagen powders. Dietary supplements are regulated as foods, not as drugs, by the US Food and Drug Administration (FDA). Therefore, manufacturers do not need to provide any proof of safety, efficacy, or quality prior to sale. This is of serious concern, as many adverse effects due to supplement components have been reported. The potential risks cover multiple categories. These include acute toxicities, such as choking, as well as chronic toxicities, such as increased risk of diabetes. Teratogenicity and interactions with drugs and laboratory testing have been documented in research studies. Other risks include potentially increased risk of cancer with long-term use, allergic reactions, and others. It is vital that physicians educate their patients on these risks. As no post-marketing surveillance programs are required for supplements, our understanding of supplement risks is incomplete. Physicians should be wary of these risks and encourage further research and regulation.

Safety Concerns of Skin, Hair and Nail Supplements in Retail Stores.

BACKGROUND: Dietary supplements promoted for "skin, hair, and nail" health are becoming increasingly popular, although there is a lack of regulatory oversight. As no centralized database or repository for these supplements is available, the aim of this study was to provide an overview of supplements in a sample of retail stores, with a focus on safety concerns. METHODS: Dermatology supplements were defined as those that featured the words "skin", "hair", "nails", "beauty", or "glow" in the product name or tagline. Seven stores including drug, grocery, department, and cosmetics stores were surveyed within a three-mile radius. Data were extracted from the Supplement Facts label of each product. RESULTS: A total of 176 separate supplements were identified, containing a total of 255 distinct ingredients. These included vitamins, minerals, food extracts, botanicals, animal products (collagen, fish oils), amino acids, a hormone, and distinct microbial strains. CONCLUSION: This survey of "dermatology" supplements available in local retailers raised several safety concerns, including potential interactions, teratogenicity risks, a lack of independent third-party testing, lack of warning labels, and nutrient "overdosing". Given limited regulation of dietary supplements, it is imperative that physicians educate patients on the potential risks. These include risks related to supplement ingredients and dosages, as well as risks related to the lack of regulatory oversight. Patients must also be educated about the multiple gaps in our knowledge of dietary supplements, especially in terms of efficacy and long-term safety.

Skin, Hair, and Nail Supplements: Marketing and Labeling Concerns.

Background and objective Dietary supplements advertised to "boost collagen" or for "skin, hair, and nail" health are becoming increasingly popular, despite a lack of evidence to support their use. These products are not regulated by the United States (U.S.) Food and Drug Administration (FDA), and hence there is no centralized database listing current products. The goal of this study was to document and examine the labeling and marketing methods of these products. Methods Supplements including the words "glow," "beauty," "skin," "hair," or "nails" on the label were included in the sample. Seven stores within a 3-mile radius were included. Results A total of 176 unique supplements were identified. It was found that most products lacked independent testing; many utilized outdated daily values (DVs) of nutrients. Some had confusing dosing instructions, and most products made health-related marketing claims. Conclusion Dermatologists and primary care providers should be aware of the marketing claims commonly made by these products. Patients should be educated that these claims are generally not verified by independent testing agencies, the U.S. FDA, or by high-quality randomized control trials.

Association of Marijuana, Mental Health, and Tobacco in Colorado.

OBJECTIVES: Marijuana's evolving legality may change marijuana use patterns in adults. Co-use of marijuana and tobacco are strongly associated, and populations with mental health disorders are disproportionately likely to use either substance, but neither association has been assessed in the context of legal recreational marijuana. We assessed the associations of tobacco smoking with marijuana use and with mental health disorders in Colorado in 2015. METHODS: Data came from a population-based survey of adults (n = 8023). Multiple logistic regressions were used with current tobacco smoking as the primary outcome. Past 30-day marijuana use and mental health status were the independent variables of interest. Covariates included age, sex, ethnicity, poverty level, and education. RESULTS: Adults who used marijuana in the past 30 days had 3.4 (95% confidence interval [CI] 2.7, 4.2) greater odds of currently smoking tobacco compared to adults who had not recently used marijuana, after adjusting for sociodemographic and economic factors. A mental health disorder was independently associated with tobacco smoking (adjusted odds ratio [OR] 1.7, 95% CI 1.4, 2.1). Prevalence of co-use among adults self-reporting a mental health disorder was significantly higher compared those without a mental health disorder (11.1% vs 4.3%; P < 0.0001). CONCLUSIONS: This study examined the associations between mental health, marijuana use, and tobacco smoking after the legalization of recreational marijuana in Colorado. Adults using marijuana and/or self-reporting a mental health disorder were more likely to smoke tobacco and should be targeted for cessation interventions.

Discontinuation of nicotine replacement therapy among smoking-cessation attempters.

BACKGROUND: Nicotine replacement therapy (NRT) doubles successful quitting, but more than half of NRT users do not comply with optimal treatment regimens. METHODS: From the 2005 Colorado state tobacco survey, quit attempters who utilized NRT (N=366) were analyzed in spring 2007. Descriptive and regression analyses were used to examine reasons for discontinuing NRT, length of time on NRT, and quit intentions. RESULTS: The reasons for discontinuing NRT were resuming smoking (34%), side effects (17%), NRT not helping with quitting (14%), quitting smoking (10%), and cost (5%). Poverty, age, and non-Latino minority status were associated with reasons for discontinuation other than quitting smoking. Having side effects was associated with a short duration of NRT use and 95% lower odds of intending to quit in the next month. CONCLUSIONS: In the first population-level study examining reasons for discontinuing NRT, general-population smokers who initiate NRT use when attempting to quit are highly likely to discontinue NRT prematurely. Age and culturally-appropriate medication management interventions may increase NRT compliance and improve cessation outcomes.

Smoking cessation behaviors among persons with psychiatric diagnoses: results from a population-level state survey.

BACKGROUND: Persons with psychiatric illnesses are disproportionally affected by tobacco use, smoking at rates at least twice that of other adults. Intentions to quit are known to be high in this population, but population-level cessation behaviors and attitudes by mental health (MH) diagnosis are not well known. METHODS: A population-level survey was conducted in 2008 to examine state-level tobacco attitudes and behaviors in Colorado. Respondents were eligible for the study if they had non-missing values for smoking status (n=14,118). Weighted descriptive and multivariate analyses were conducted of smoking prevalence, cessation behaviors, and attitudes toward cessation by MH status and specific diagnosis. RESULTS: Among respondents with MH diagnoses, smoking was twice as prevalent as among respondents without an MH diagnosis, adjusted for demographic characteristics (adjusted odds ratio 2.2, 95% confidence interval 1.6-3.1). Compared to smokers without an MH diagnosis, those with MH diagnoses were more likely to attempt quitting (58.7% vs. 44.4%, p<0.05), use nicotine replacement therapy more often, and succeed in quitting at similar rates. Smokers with anxiety/PTSD were less likely to quit successfully compared those with other MH diagnoses (0.7% vs. 11.9%, p=0.03). CONCLUSIONS: This population-level analysis found that smokers with mental illness are more likely than those without mental illness to attempt quitting and to use cessation treatment at similar rates, but those with anxiety are less likely to achieve short-term abstinence. Additional approaches are needed for smokers with mental illness in order to reach and sustain long-term abstinence from smoking.

Factors in nonadherence to quitline services: smoker characteristics explain little.

BACKGROUND: Quitlines offer evidence-based, multisession coaching support for smoking cessation in the 50 U.S. states, Canada, and several other countries. Smokers who enroll in quitline services have, ipso facto, shown readiness to attempt to quit, but noncompletion of coaching services appears widespread and has not been widely investigated. The current study explored the magnitude and correlates of quitline service abandonment. METHOD: A state's quitline intake, coaching, and nicotine patch/gum utilization data were obtained for smokers who enrolled during the period July 2007 to June 2008 (n = 20,882). Analyses examined demographic, socioeconomic status, nicotine dependence-related, and nicotine replacement therapy--utilization factors associated with completion of only one coaching session (of five offered). RESULTS: Almost half of enrollees (47.8%) completed only one session. All significant predictors together explained less than 4% of variance; not being sent nicotine replacement therapy was most strongly correlated with completion of only one session. A framework is proposed for directing research toward reducing quitline service nonadherence. CONCLUSIONS: Premature user abandonment of coaching calls is widespread within a quitline. Further research should determine the extent of the problem in national quitline systems, increase knowledge of mediators of nonadherence, and develop strategies for increasing coaching completion.

Rates and reasons: disparities in low intentions to use a state smoking cessation quitline.

PURPOSE: Little is known about population-level rates and reasons for low intentions to call the quitline, a widely available evidence-based smoking cessation treatment. DESIGN: This study is a secondary analysis of the 2008 Colorado Adult Tobacco Attitudes and Behavior Survey. SETTING: This is a population-based telephone survey of adults in Colorado. SUBJECTS: Study respondents (N = 1662) included current adult smokers who had heard of the Colorado QuitLine (QL) and did not report that they never intend to quit. MEASURES: Outcome measures included intent to call the QL, self-reported reasons for not intending to call the QL, and knowledge of QL services. ANALYSIS: Descriptive and multivariate logistic regression analyses were used for each outcome variable. All analyses were weighted for complex survey design to represent the population of Colorado. RESULTS: Overall 45.6% of smokers intend never to call the QL. In multivariate analysis, Latinos (odds ratio [OR] = 2.5; 95% confidence intervals [CI], 1.4, 4.7), gay/lesbian/bisexuals (OR = 5.2; 95% CI, 2.4, 11.4), and those with no insurance compared with Medicaid (OR = 3.8; 95% CI, 1.1, 13.0) were most likely to intend never to call the QL. Perceiving no need for assistance (34.8%) was the most common reason for not calling. CONCLUSIONS: A majority of smokers have no or weak intentions of ever calling the QL, with variation by subgroup. Reasons for not intending to call can inform targeted media campaigns to increase QL reach.

Clinical faxed referrals to a tobacco quitline: reach, enrollment, and participant characteristics.

BACKGROUND: Faxed referrals from healthcare providers may provide a sustainable, low-cost mechanism for enrolling tobacco users in statewide quitlines, but few studies have evaluated implementation in real-world settings. This study evaluated the reach rates, enrollment rates, and participant characteristics of faxed referrals to the Ohio Tobacco Quit Line. METHODS: This observational study analyzed reach and enrollment rates from June 2006 to October 2007. Demographics and tobacco-use characteristics of 1616 Quit Line enrollees recruited through faxed referrals were compared to those of enrollees who were not fax-referred. RESULTS: A total of 6951 faxed referrals were received during the study period, increasing from an average of 68 per month before promotional initiatives to 412 per month during the study period. However, almost 60% of fax-referred individuals could not be reached for enrollment. Compared to other enrollees (n=36,273), fax-referred enrollees (n=1616) were more likely to be women, aged >/=35 years, have less than a high school education, have at least one comorbid condition, and be uninsured or publicly insured. CONCLUSIONS: Faxed referrals from healthcare providers are widely promoted to increase quitline participation and to assist providers in implementing cessation treatment. This study found low enrollment rates from faxed referrals; substantial efforts led to relatively few patients receiving quitline services. However, faxed referrals may reach populations who traditionally have less access to cessation aids. More research is needed to determine how to efficiently and effectively solicit faxed referrals from healthcare providers and to increase quitline enrollment rates among fax-referred smokers as well as to determine the extent to which faxed referrals influence quit outcomes.

Differences in smoking duration between Latinos and Anglos.

A smoker's risk of disease and death from cigarettes is related directly to the duration of smoking. The present study compared duration of smoking between a state-level population of Anglo versus highly acculturated Latino ever-smokers (N = 6,100). Kapla-Meier analysis was used to obtain weighted median smoking duration. Weighted Cox proportional hazard models were used to evaluate the relative likelihood of continued smoking, adjusted for demographics, smoking history, home and workplace smoking restrictions, and socioeconomic covariates (education, health insurance status, and poverty level). On average, Latinos continued smoking longer than Anglos (M = 30 years vs. 27 years; weighted Cox HR = 0.73; 95% CI = 0.60-0.89). The disparity remained significant when adjusted for demographic, smoking history, and smoking-rule covariates but was not significant when adjusted for socioeconomic status (HR = 0.89, 95% CI = 0.73-1.09). Education alone accounted for the majority of the disparity, more so than poverty or health insurance status. We conclude that highly acculturated Latino smokers may be at greater risk of cigarette disease and death related to longer duration of smoking associated with lower socioeconomic status.