Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes.

OBJECTIVES: Smoking prevalence remains high among low-income smokers. Understanding processes (eg, withdrawal, craving, motivation) in early smoking cessation is crucially important for designing effective interventions for this population. METHODS: This is a secondary analysis of a novel, in-session sampling intervention (ie, In Vivo) as compared with standard care behavioral smoking cessation counseling (SC) among community-dwelling low-income smokers (n = 83). This analysis examined the effect of 5 in-session sampling interventions on cessation-related processes and perceived advantages or disadvantages of nicotine replacement therapy (NRT) products over time using daily diaries. RESULTS: The In Vivo treatment had an early positive impact in terms of decreasing withdrawal symptoms and cravings, and increasing perceived advantages to NRT, with moderate to large effect sizes. Results also showed that the treatment effectively reduced withdrawal symptoms and cravings in-session, with small-to-medium and medium-to-large effect sizes, respectively. In-session reduction of withdrawal symptoms and cravings did not occur for the SC group, with the exception of decreased withdrawal symptoms occurring during week 4. The In Vivo treatment did not impact quit goal, desire to quit, abstinence self-efficacy, perceived difficulty in quitting, motivational engagement, or perceived disadvantages to NRT. The In Vivo group reported less daily cigarette use relative to the SC group, in addition to reporting less cigarette use on days they reported greater combination NRT use. CONCLUSIONS: There is preliminary support for this In Vivo treatment over SC in reducing withdrawal, craving, and the number of cigarettes smoked per day, as well as promoting perceived advantages of NRT among low-income smokers.

An Open-label Pilot Study of NicoBloc as a Novel Smoking Cessation Intervention.

INTRODUCTION: NicoBloc is a viscous fluid applied to the cigarette filter designed to block tar and nicotine. This novel and understudied smoking cessation device presents a nonpharmacological means for smokers to gradually reduce nicotine and tar content while continuing to smoke their preferred brand of cigarette. This pilot study aimed to assess the feasibility, acceptability, and initial efficacy of NicoBloc as compared with nicotine replacement therapy (nicotine lozenge). METHODS: A community sample of predominately Black smokers (N = 45; 66.7% Black) were randomized to receive NicoBloc or nicotine lozenge. Both groups engaged in 4 weeks of smoking cessation therapy followed by 2 months of independent usage with monthly check-ins to assess medication adherence. The intervention lasted 12 weeks, and the study concluded with a 1-month postintervention follow-up visit (week 16). RESULTS: NicoBloc was comparable with nicotine lozenge in smoking reduction, feasibility, symptom adverse effects, and reported acceptability at week 16. Participants in the lozenge group endorsed higher treatment satisfaction ratings during the intervention and lower cigarette dependence. Adherence to NicoBloc was superior throughout the study. CONCLUSION: NicoBloc was feasible and acceptable to community smokers. NicoBloc presents a unique, nonpharmacological intervention. Future research is needed to examine whether this intervention may be most effective in subpopulations where pharmacological approaches are restricted or in combination with established pharmacological methods such as nicotine replacement therapy.

Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use.

BACKGROUND: Despite the demonstrated value of opioid overdose education and naloxone distribution (OEND) programs, uptake and utilization remains low. Accessibility to OEND is limited and traditional programs may not reach many high-risk individuals. This study evaluated the effectiveness of online opioid overdose and naloxone administration education and the impact of naloxone possession. METHODS: Individuals with self-reported illicit use of opioids were recruited via Craigslist advertisements and completed all assessments and education online via REDCap. Participants watched a 20-minute video outlining signs of opioid overdose and how to administer naloxone. They were then randomized to either receive a naloxone kit or be given instructions on where to obtain a kit. Effectiveness of training was measured with pre- and post-training knowledge questionnaires. Naloxone kit possession, overdoses, opioid use frequency, and treatment interest were self-reported on monthly follow-up assessments. RESULTS: Mean knowledge scores significantly increased from 6.82/9.00 to 8.22 after training (t(194)=6.85, p <0.001, 95% CI[1.00, 1.81], Cohen's d=0.85). Difference in naloxone possession between randomized groups was significant with a large effect size (p <0.001, diff=0.60, 95% CI[0.47, 0.73]). A bidirectional relationship was found between naloxone possession and frequency of opioid use. Overdoses and treatment interest were similar across possession status. CONCLUSIONS: Overdose education is effective in online video format. Disparity in naloxone possession across groups indicates barriers to obtaining naloxone from pharmacies. Naloxone possession did not influence risky opioid use or treatment interest and its impact on frequency of use warrants further investigation. TRIAL REGISTRATION: Clinitaltrials.gov-NCT04303000.

Feasibility and acceptability of online opioid overdose education and naloxone distribution: Study protocol and preliminary results from a randomized pilot clinical trial.

Drug overdose is the leading cause of accidental death in the United States, with over 70% of drug related fatalities resulting from the use of opioids. Federal agencies have responded to this crisis with various recommendations including enhancing harm reduction approaches such as training laypersons to administer naloxone through Opioid Overdose Education and Naloxone Distribution (OEND) programs. Several studies have demonstrated that OEND programs effectively reduce opioid overdose mortality and are both safe and cost-effective, however, they are typically implemented in urban areas as part of large medical center research programs, needle exchanges, or drug treatment programs. Individuals living in areas without these programs or services lack access to critical and life-saving OEND. The current study examined the acceptability and feasibility of online recruitment, online opioid overdose education, and remote distribution of naloxone kits. Persons who illicitly use opioids and are at risk for overdose were recruited through online media and completed an opioid use questionnaire. If interested in receiving opioid overdose and naloxone administration training, participants completed pre- and post-intervention knowledge questionnaires, engaged in audiovisual training, and were randomized to either receive a naloxone kit or be given information on where they could obtain one. Preliminary results indicate feasibility and acceptability as evidenced by strong recruitment and retention, as well as high participant satisfaction ratings. Successful implementation of remote OEND through this project supports future employment of similar remote programs to expand this critical harm reduction strategy to high-risk individuals in areas lacking traditional OEND programs. Trial Registration #: Clinitaltrials.gov- NCT04303000.

Psychiatric Disorders and HIV Drug Risk Behaviors Among Individuals Under Community Correctional Supervision.

The prevalence of human immunodeficiency virus (HIV) is nearly three times higher in the incarcerated population than in the general population in the United States, and over half of the incarcerated population has a psychiatric diagnosis. Individuals under community corrections supervision continue to receive limited attention regarding HIV prevention and surveillance. Anxiety-related, depressive-related, and post-traumatic stress disorders are high in the community corrections population and may be potential correlates of HIV risk behaviors. Examining the link between psychiatric diagnosis and HIV risk behavior within the community correctional setting may shed light on who is at greatest risk for HIV. Individuals within community corrections who participated in a clinical trial completed questionnaires and semistructured interviews to screen for psychiatric disorders and HIV risk behaviors. Multivariate analyses revealed that individuals of younger age, of White race, and with anxiety disorders engaged in greater HIV drug risk behaviors, providing preliminary implications for whom testing and prevention efforts should be emphasized.

A Pilot Study of Nicotine Replacement Therapy Sampling and Selection to Increase Medication Adherence in Low-Income Smokers.

INTRODUCTION: Adherence to smoking cessation medications remains suboptimal, particularly among low-income smokers. Guided, experiential sampling of nicotine replacement therapies (NRTs) may increase NRT adherence and smoking cessation over gold standard counseling plus NRT. The present pilot study aimed to examine feasibility, acceptability, and preliminary efficacy of a novel experiential intervention. AIMS AND METHODS: This pilot randomized controlled trial (N = 83) compared gold standard smoking cessation treatment (four weekly sessions of behavioral counseling followed by self-selected combination NRT in week 5) to a novel experiential approach (ie, In Vivo; four weekly sessions of sampling each short form of NRT-gum, lozenge, inhaler, nasal spray-in-session while wearing the nicotine patch followed by NRT selection in week 5). Both groups received 8 weeks of nicotine patch plus their selected additional short form NRT for smoking cessation followed by a 1-month assessment. RESULTS: Screening and enrollment rates supported feasibility. In Vivo was comparable in acceptability with the gold standard of care intervention; however, there was greater attrition in the In Vivo group compared with the gold standard of care group. Results suggested higher medication adherence and improvements in smoking behavior in the In Vivo intervention; with generally small-to-medium effect sizes. CONCLUSIONS: This experiential approach to sampling NRT is feasible and acceptable to low-income people who smoke. This intervention may increase adherence and reduce harmful smoking behavior but needs to be tested on a larger scale. IMPLICATIONS: Medication adherence remains a significant impediment to the successful smoking cessation. The results of this study suggest that guided sampling of NRT products improves adherence among low-income smokers. Additionally, this approach yielded greater improvements in smoking behavior compared with gold standard smoking cessation treatment. This intervention shows promise as a feasible smoking cessation treatment for low-income smokers.

Examining the neighborhood-level socioeconomic characteristics associated with fatal overdose by type of drug involved and overdose setting.

BACKGROUND: Fatal drug overdose in the United States is a public health crisis fueled by increased opioid and polysubstance use. Few studies have compared the neighborhood-level socioeconomic characteristics associated with overdoses of various substance classes and, to our knowledge, no investigation has yet assessed these factors in relation to polysubstance overdoses. Further, no study has determined whether socioeconomic conditions predict other contextually relevant aspects of overdoses such as whether they occur at-home or out-of-home. METHODS: Overdose data (2015-2018) were obtained from the Coroner/Medical Examiner's Office of Jefferson County, Alabama. The toxicology results of decedents with a known overdose locations (N = 768) were assessed for the presence of synthetic opioids, natural and semi-synthetic opioids, heroin, stimulants, benzodiazepines, and alcohol. Socioeconomic characteristics were obtained from the Unites States Census Bureau at the census tract level. RESULTS: Stimulant overdoses occurred in neighborhoods with the highest rates of disadvantage relative to other substance and polysubstance overdose types. The majority of included overdoses occurred at-home (63.7%) and an index of socioeconomic disadvantage predicted overdose rates for both at-home and out-of-home overdoses. Heroin overdose deaths were more likely to occur at-home while polysubstance stimulant-heroin overdoses were more common out-of-home. CONCLUSIONS: An index of socioeconomic disadvantage was generally predictive of overdose, regardless of the setting in which the overdose occurred (in-home vs. out-of-home). The associations between neighborhood-level socioeconomic characteristics and fatal overdose can be tailored by substance type to create targeted interventions. Overdose setting may be an important consideration for future policy efforts, as overdoses were nearly twice as likely to occur at-home.

Pharmacies and features of the built environment associated with opioid overdose: A geospatial comparison of rural and urban regions in Alabama, USA.

BACKGROUND: Elements of the physical environment have been shown to influence health behaviors including drug use and overdose mortality. Throughout the opioid epidemic in the United States, rural regions have been disproportionately affected by opioid overdose. Although the relationship between the urban built environment and opioid overdose has been established, little is known as to how trends may differ in rural areas. METHODS: Risk terrain modeling was used as a spatial analytical approach to assess environmental features that significantly increase the risk of opioid overdose in Jefferson County, Alabama. Spatial risk assessments were conducted for urban and rural regions as well as for the county as a whole. Criminogenic, opioid-related, and community variables were included and compared across spatial risk models. RESULTS: The geographic context, rural or urban, influenced the relationship between environmental features and opioid overdose. In rural areas, community features such as bus stops and public schools were related to the occurrence of opioid overdose. In urban areas, inpatient treatment centers, transitional living facilities, express loan establishments, and liquor vendors were significantly related to the locations of opioid overdose. CONCLUSION: Risk terrain modeling can be used to locate high-risk areas for opioid overdose while identifying factors that are contributing to the risk of events occurring in communities. The patterns of overdose risk differ in rural and urban contexts and may be used to inform the placement of treatment and prevention resources.

Naloxone Training From Nonmedical Personnel: Benefits Before, During, and After Overdose Events.

OBJECTIVES: Drug overdose death rates in the United States have increased exponentially over the past 2 decades, primarily driven by fatal opioid overdoses. To combat this epidemic, naloxone training programs have become prevalent, but still remain widely underutilized. The purpose of the current study was to assess the benefits of a brief training with differing educational approaches (individual training versus training in dyads) as well as the outcomes following overdose reversals. METHODS: Persons who use opioids (N = 448) were recruited from 4 sites including treatment facilities, inpatient hospitals, and criminal justice locations over a 3-year period. Training was delivered by nonmedical personnel and focused on safe naloxone usage and recognizing overdose signs. Overdose and naloxone knowledge were assessed before and following training with a 10-item questionnaire. Participants were trained individually, in a dyad with a partner who used opioids (PO), or in a dyad with a partner who did not use opioids (PNO). RESULTS: All training groups displayed an increased knowledge of naloxone and overdose situations following training. Approximately 11% of participants (n = 47) reported using their naloxone kit and 97.7% of those resulted in successful overdose reversals. Kits were primarily used by the trained participant on a third-party individual. CONCLUSIONS: The results of the current study substantiate the effectiveness of naloxone in reversing overdose symptoms. A brief, 15-minute naloxone training delivered by nonmedical personnel enhanced overdose knowledge and led to positive reversal outcomes. Training persons who use opioids in dyads may offer additional benefits and improve follow-up reporting.

Attitudes and availability: A comparison of naloxone dispensing across chain and independent pharmacies in rural and urban areas in Alabama.

BACKGROUND: Fatal opioid overdoses remain the leading cause of accidental deaths in the United States, which have contributed to implementation of standing order laws that allow pharmacists to dispense naloxone to patients. Although pharmacy distribution of naloxone is a promising approach to increase access to this intervention, understanding barriers preventing greater uptake of this service is needed. METHODS: Data for the current study were collected via telephone survey assessing the availability of various formulations of naloxone at chain and independent pharmacies in rural and urban areas in Birmingham, Alabama (N = 222). Pharmacists' attitudes toward naloxone and potential barriers of pharmacy naloxone distribution were also assessed. One-way analysis of variance (ANOVA) and logistic regression analyses were utilized to examine differences in stocking of naloxone in chain and independent pharmacies and to determine predictors of the number of kits dispensed by pharmacies. RESULTS: Independent pharmacies were less likely to have naloxone in stock, especially those in rural areas. Furthermore, rural pharmacies required more time to obtain all four formulations of naloxone, and offered less extensive training on naloxone use. Pharmacists endorsing the belief that naloxone allows avoidance of emergent treatment in an overdose situation was associated with fewer dispensed kits by the pharmacies. Over 80% of pharmacists endorsed at least one negative belief about naloxone (e.g., allowing riskier opioid use). Pharmacists noted cost to patients and the pharmacy as contributing to not dispensing more naloxone kits. CONCLUSION: The current study demonstrates the lower availability of naloxone stocked at pharmacies in independent versus chain pharmacies, particularly in rural communities. This study also highlights several barriers preventing greater naloxone dispensing including pharmacists' attitudes and costs of naloxone. The potential benefit of standing order laws is not being fully actualized due to the structural and attitudinal barriers identified in this study. Strategies to increase naloxone access through pharmacy dispensing are discussed.

Self-initiated gradual smoking reduction among community correction smokers.

INTRODUCTION: Smoking remains the leading cause of preventable death in the United States. Many smoking cessation guidelines advise smokers to quit precipitately; however, most quit attempts involve a more gradual cessation. Characteristics of individuals who tend to reduce prior to quitting and the effectiveness of pre-quit reduction are not well understood. This study examined individual differences and smoking cessation outcomes between individuals who self-initiated gradual reduction in cigarettes per day (CPD) and those who did not reduce prior to quit date. METHODS: This study is a secondary analysis from a randomized clinical trial of smoking cessation with pharmacotherapy among individuals under community corrections supervision. We compared participants who self-initiated smoking reduction by at least 25% between baseline and the first treatment session (n = 128) to participants who either increased or did not reduce smoking between baseline and the first treatment session (n = 354). RESULTS: African American race, no previous cigar smoking, no previous use of pharmacotherapy for smoking cessation, less withdrawal symptoms at baseline, and older age at first smoking were associated with being a self-initiated gradual reduction in univariate analyses. Individuals who self-initiated gradual reduction also had a had a greater likelihood of achieving at least one quit during the one-year study period as compared to those who did not reduce prior to the intervention. CONCLUSIONS: Individuals who self-initiate gradual reduction differ from those who increase or do not change their smoking prior to a quit date. Gradual reduction also increased success in quitting.