Menthol versus tobacco e-liquid flavor: Impact on acute subjective effects, puff patterns, and intentions for use among Black and White menthol smokers.

BACKGROUND: The proposed FDA product standard to prohibit menthol as a characterizing flavor in combustible cigarettes has the potential to significantly reduce tobacco-related health disparities. Whether a menthol e-liquid product standard would improve or hinder public health is unknown. No known research has directly examined the impact of menthol vs. tobacco flavored e-liquid use on acute e-cigarette use patterns, subjective experience, behavioral intentions, and craving and withdrawal among menthol cigarette smokers. METHODS: Black (n = 47) and White (n = 4) nicotine-deprived menthol smokers with limited e-cigarette experience completed two counterbalanced in-laboratory 30-minute ad libitum vaping sessions with menthol and tobacco nicotine salt-based e-liquid in a randomized crossover pilot trial design. Questionnaires assessed reductions in craving and withdrawal and post-session subjective experience and behavioral intentions. Puff topography was measured continuously throughout each vaping session. RESULTS: Measures of puff topography did not differ significantly by e-liquid flavor (all p > .40). Similarly, menthol and tobacco flavored e-cigarettes were both rated positively in terms of subjective effects and behavioral intentions (all p > .10) and about 40 % of participants reported a preference for the tobacco-flavored e-liquid. Finally, participants showed comparable reductions in craving (p = .210) and withdrawal (p = .671) from pre- and post-session regardless of e-liquid flavor. CONCLUSIONS: Among menthol smokers in a lab-based setting, findings suggest that menthol vs tobacco e-liquid flavor has little impact on acute changes in puff patterns, subjective experience, behavioral intentions, or craving and withdrawal.

The impact of blunt use on smoking abstinence among Black adults: Secondary analysis from randomized controlled smoking cessation clinical trial.

INTRODUCTION: People who smoke cigarettes are more likely than people who do not to use cannabis, including blunts, a tobacco product containing nicotine and marijuana. Blunts represent a challenge for cessation trials because nicotine could make stopping cigarettes more difficult. Few studies have examined the impact of blunt use on individuals actively engaged in a cigarette quit attempt. METHODS: Blunt use was assessed at baseline, Weeks 4, 8, 12, 16, and 26 among Black adult people who smoke enrolled in a double-blind, placebo-controlled, randomized trial of varenicline (VAR, n = 300) versus placebo (PBO, n = 200) for smoking cessation. Participants were categorized as ever blunt (blunt use reported at any timepoint) versus non-blunt (no blunt use reported). The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at Weeks 12 and 26. Logistic regression examined the effects of treatment and blunt use on abstinence. RESULTS: 75 participants (mean age 45.6 years (SD = 12.5, range: 22,80); 32 (42%) female) reported blunt use. Logistic regression analyses showed no treatment by blunt use interaction or significant main effect of blunt use on smoking abstinence at Weeks 12 or 26 (p > 0.05). After adjusting for treatment, those who used blunts had statistically similar odds of quitting at Week 12 (OR: 0.68, 95% CI: 0.31, 1.5) and Week 26 (OR: 0.84, 95% CI: 0.38, 1.87) as those who never used blunts during the study. DISCUSSION: Blunt use had no statistically significant impact on cessation among participants in a smoking cessation clinical trial. Future trials are needed in which the target of cessation is all combustible products.

Nicotine Delivery and Changes in Withdrawal and Craving During Acute Electronic Cigarette, Heated Tobacco Product, and Cigarette Use Among a Sample of Black and White People Who Smoke.

INTRODUCTION: E-cigarettes and heated tobacco products (HTPs) may serve as potential options for harm reduction for smokers if they possess reward profiles similar to cigarettes. Little is known about the abuse liability of HTPs and e-cigarettes versus cigarettes in racial/ethnic minority smokers. AIMS AND METHODS: Twenty-two nicotine-deprived people who smoke (black [n = 12] and white [n = 10]) completed three visits that included a standardized 10-puff bout followed by a 50-minute ad libitum use assessment with their usual brand cigarette (UBC), an e-cigarette, and HTP. Visits were completed in a randomized crossover design and were separated by a minimum 48-hour washout period. Assessments included plasma nicotine, Cmax, and reductions in craving and withdrawal. RESULTS: UBC delivered significantly greater levels of nicotine compared to the e-cigarette (p < .001) and HTP (p < .01) during both the standardized and ad libitum sessions. HTP delivered more nicotine than the e-cigarette during the standardized puffing session (p = .047) but not the ad libitum session. Only craving during the standardized puffing session and not the ad libitum session showed significant differences across products (p < .001) such that UBC resulted in the greatest reduction followed by HTP and e-cigarette. CONCLUSIONS: Despite greater nicotine delivery from the UBC compared to e-cigarette and HTP, participants reported reductions in craving and withdrawal across products, particularly following ad libitum use. IMPLICATIONS: Use of participant's UBCs (UBC) resulted in greater nicotine delivery compared to both the e-cigarette and HTP. Despite this relative difference in nicotine delivery, participants reported reductions in craving and withdrawal across products, particularly following ad libitum use. These findings suggest that in this sample of black and white people who smoke, HTPs and e-cigarettes provided significant relief from negative symptoms that maintain smoking.

Concurrent Choice Assessment of Preference and Substitutability of E-cigarettes and Heated Tobacco Products for Combustible Cigarettes Among African American and White Smokers.

INTRODUCTION: Alternative nicotine delivery products, including electronic cigarettes (e-cigarettes) and heated tobacco products (HTPs), contain fewer toxicants than combustible cigarettes and offer a potential for harm reduction. Research on the substitutability of e-cigarettes and HTPs is crucial for understanding their impact on public health. This study examined subjective and behavioral preferences for an e-cigarette and HTP relative to participants' usual brand combustible cigarette (UBC) in African American and White smokers naïve to alternative products. AIMS AND METHODS: Twenty-two adult African American (n = 12) and White (n = 10) smokers completed randomized study sessions with their UBC and study provided e-cigarette and HTP. A concurrent choice task allowed participants to earn puffs of the products but placed UBC on a progressive ratio schedule, making puffs harder to earn, and e-cigarette and HTP on a fixed ratio schedule to assess behavioral preference for the products. Behavioral preference was then compared to self-reported subjective preference. RESULTS: Most participants had a subjective preference for UBC (n = 11, 52.4%), followed by an equal preference for e-cigarette (n = 5, 23.8%) and HTP (n = 5, 23.8%). During the concurrent choice task, participants showed a behavioral preference (i.e., more earned puffs) for the e-cigarette (n = 9, 42.9%), followed by HTP (n = 8, 38.1%), and UBC (n = 4, 19.1%). Participants earned significantly more puffs of the alternative products compared to UBC (p = .011) with no difference in earned puffs between e-cigarettes and HTP (p = .806). CONCLUSIONS: In a simulated lab setting, African American and White smokers were willing to substitute UBC for an e-cigarette or HTP when the attainment of UBC became more difficult. TRIAL REGISTRATION: NCT04646668. IMPLICATIONS: Findings suggest that African American and White smokers are willing to substitute their UBC for an alternative nicotine delivery product (e-cigarette or HTP) when the attainment of cigarettes became more difficult in a simulated lab setting. Findings require confirmation among a larger sample under real-world conditions but add to growing evidence suggesting the acceptability of alternative nicotine delivery products among racially diverse smokers. These data are important as policies that limit the availability or appeal of combustible cigarettes are considered or enacted.

Comparative and cost effectiveness of telemedicine versus telephone counseling for smoking cessation.

BACKGROUND: In rural America, cigarette smoking is prevalent and health care providers lack the time and resources to help smokers quit. Telephone quitlines are important avenues for cessation services in rural areas, but they are poorly integrated with local health care resources. OBJECTIVE: The intent of the study was to assess the comparative effectiveness and cost effectiveness of two models for delivering expert tobacco treatment at a distance: telemedicine counseling that was integrated into smokers' primary care clinics (Integrated Telemedicine-ITM) versus telephone counseling, similar to telephone quitline counseling, delivered to smokers in their homes (Phone). METHODS: Smokers (n=566) were recruited offline from 20 primary care and safety net clinics across Kansas. They were randomly assigned to receive 4 sessions of ITM or 4 sessions of Phone counseling. Patients in ITM received real-time video counseling, similar to Skype, delivered by computer/webcams in clinic exam rooms. Three full-time equivalent trained counselors delivered the counseling. The counseling duration and content was the same in both groups and was available in Spanish or English. Both groups also received identical materials and assistance in selecting and obtaining cessation medications. The primary outcome was verified 7-day point prevalence smoking abstinence at month 12, using an intent-to-treat analysis. RESULTS: There were no significant baseline differences between groups, and the trial achieved 88% follow-up at 12 months. Verified abstinence at 12 months did not significantly differ between ITM or Phone (9.8%, 27/280 vs 12%, 34/286; P=.406). Phone participants completed somewhat more counseling sessions than ITM (mean 2.6, SD 1.5 vs mean 2.4, SD 1.5; P=.0837); however, participants in ITM were significantly more likely to use cessation medications than participants in Phone (55.9%, 128/280 vs 46.1%, 107/286; P=.03). Compared to Phone participants, ITM participants were significantly more likely to recommend the program to a family member or friend (P=.0075). From the combined provider plus participant (societal) perspective, Phone was significantly less costly than ITM. Participants in ITM had to incur time and mileage costs to travel to clinics for ITM sessions. From the provider perspective, counseling costs were similar between ITM (US $45.46, SD 31.50) and Phone (US $49.58, SD 33.35); however, total provider costs varied widely depending on how the clinic space for delivering ITM was valued. CONCLUSIONS: Findings did not support the superiority of ITM over telephone counseling for helping rural patients quit smoking. ITM increased utilization of cessation pharmacotherapy and produced higher participant satisfaction, but Phone counseling was significantly less expensive. Future interventions could combine elements of both approaches to optimize pharmacotherapy utilization, counseling adherence, and satisfaction. Such an approach could commence with a telemedicine-delivered clinic office visit for pharmacotherapy guidance, and continue with telephone or real-time video counseling delivered via mobile phones to flexibly deliver behavioral support to patients where they most need it-in their homes and communities. TRIAL REGISTRATION: Clinicaltrials.gov NCT00843505; http://clinicaltrials.gov/ct2/show/NCT00843505 (Archived by WebCite at http://www.webcitation.org/6YKSinVZ9).

Design and participant characteristics of a randomized-controlled trial of telemedicine for smoking cessation among rural smokers.

INTRODUCTION: In rural America cigarette smoking is prevalent, few cessation services are available, and healthcare providers lack the time and resources to help smokers quit. This paper describes the design and participant characteristics of Connect2Quit (C2Q), a randomized control trial (RCT) that tests the effectiveness and cost-effectiveness of integrated telemedicine counseling delivered by 2-way webcams mounted on desktop computers in participant's physician office examining rooms (ITM) versus quitline counseling delivered by telephone in participant's homes (Phone) for helping rural smokers quit. METHODS/DESIGN: C2Q was implemented in twenty primary care and safety net clinics. Integrated telemedicine consisted of real-time video counseling, delivered to patients in their primary care physician's (PCP) office. Phone counseling, was delivered to patients in their homes. All participants received educational materials and guidance in selecting cessation medications. RESULTS: The 566 participants were predominantly Caucasian (92%); 9% were Latino. Most (65%) earned <200% of Federal Poverty Level. One out of three lacked home internet access, 40% were not comfortable using computers, and only 4% had been seen by a doctor via telemedicine in the past. Hypertension, chronic lung disease, and diabetes were highly prevalent. Participants smoked nearly a pack a day and were highly motivated to quit. DISCUSSION: C2Q is reaching a rural low-income population, with comorbid chronic diseases, that would benefit greatly from quitting smoking. ITM is a good delivery model, which integrates care by holding counseling sessions in the patient's PCP office and keeps the primary care team updated on patients' progress. CLINICAL TRIALS REGISTRATION: NCT00843505.

Transverse plane pelvic rotation in adolescent idiopathic scoliosis: primary or compensatory?

Several studies have suggested that the pelvis is involved in the etiology or pathogenesis of adolescent idiopathic scoliosis (AIS). The purpose of this retrospective, cross-sectional radiographic study is to identify any correlation between the transverse plane rotational position of the pelvis in stance and operative-size idiopathic or congenital scoliosis deformities, using Scheuermann's kyphosis and isthmic spondylolisthesis patients for comparison. The hypothesis tested was that the direction of transverse pelvic rotation is the same as that for a thoracic scoliosis. As a group, AIS patients had a significant transverse plane pelvic rotation in the same direction as the thoracic curve. When subdivided into the six Lenke curve patterns, this was true for the groups with a major thoracic curve: thoracic (1), double thoracic (2) and double curve patterns (3). It was not true for patterns with a major thoracolumbar/lumbar curve: single thoracolumbar/lumbar (5) and double thoracic-thoracolumbar/lumbar (6). Nor was it true for triple (4) curves. The Lenke 1 and 2 major thoracic curves without compensatory thoracolumbar/lumbar curves did not have the predicted pelvic rotation. All congenital scoliosis patients studied had main thoracic curves and significant transverse plane pelvic rotation in the same direction as the thoracic curve. There was no transverse plane pelvic rotation in the Scheuermann's kyphosis or isthmic spondylolisthesis patients. We interpret these findings as consistent with a compensatory rotation of the pelvis in the same direction as the main thoracic curve in most patients with a compensatory thoracolumbar/lumbar curve as well as in patients with main thoracic congenital scoliosis.