"I don't think that a medication is going to help someone long-term stay off opioids": Treatment and recovery beliefs of rural Vermont family members of people with opioid use disorder.

PURPOSE: Few studies have addressed beliefs about treatment for opioid use disorder (OUD) among family members of people with OUD, particularly in rural communities. This study examined the beliefs of rural family members of people with OUD regarding treatment, including medication for OUD (MOUD), and recovery. METHODS: Semi-structured qualitative interviews were conducted with rural Vermont family members of people with OUD. Twenty family members completed interviews, and data were analyzed using thematic analysis. RESULTS: Four primary themes related to beliefs about OUD treatment emerged: (1) MOUD is another form of addiction or dependency and should be used short-term; (2) essential OUD treatment components include residential and mental health services and a strong support network involving family; (3) readiness as a precursor to OUD treatment initiation; and (4) stigma as an impediment to OUD treatment and other health care services. CONCLUSIONS: Rural family members valued mental health services and residential OUD treatment programs while raising concerns about MOUD and stigma in health care and the community. Several themes (e.g., MOUD as another form of addiction, residential treatment, and treatment readiness) were consistent with prior research. The belief that MOUD use should be short-term was inconsistent with the belief that OUD is a disease. Findings suggest a need for improved education on the effectiveness of MOUD for family members and on stigma for health care providers and community members.

Cigarette smoking and cognitive task performance: Experimental effects of very-low nicotine-content cigarettes.

Reductions in the nicotine content of cigarettes decrease smoking rate and dependence severity, but effects on cognition are less well established. The potential impacts of very-low nicotine-content (VLNC) cigarettes on cognitive task performance must be evaluated, especially in vulnerable populations. The aim of the present study is to experimentally examine the effects of VLNC cigarettes on cognitive performance. Adults who smoked daily (n = 775) from three vulnerable populations (socioeconomically disadvantaged reproductive-age women, individuals with opioid use disorder, affective disorders) were examined. Participants were randomly assigned to normal nicotine content (NNC; 15.8 mg nicotine/g tobacco) or VLNC (2.4 mg/g or 0.4 mg/g) cigarettes for 12 weeks. Response inhibition (stop-signal task), working memory (n-back task; n of 2-n of 0), and cognitive interference (nicotine Stroop task) were assessed at baseline, 2, 6, and 12 weeks. Results were analyzed using mixed-model repeated-measures analyses of variance. Extended exposure to VLNC cigarettes produced no significant changes in any measure of cognitive performance compared to NNC cigarettes. Over weeks, response times on the n-back task decreased across doses. No significant effects were observed on the stop-signal or nicotine Stroop tasks. All three vulnerable populations performed comparably on all three cognitive tasks. Extended exposure to VLNC cigarettes produced no impairments in cognitive performance on any of the assessed tasks compared to NNC cigarettes. These findings are consistent with the larger literature detailing other consequences following exposure to VLNC cigarettes and are encouraging for the adoption of a nicotine-reduction policy. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Changes in weight among individuals with psychiatric conditions or socioeconomic disadvantage assigned to smoke very low nicotine content cigarettes.

Nicotine abstinence leads to weight gain, which could be an unintended consequence of a nicotine reduction policy. This secondary analysis used weekly assessments of weight and ratings of "increased appetite/hunger/weight gain" collected in three 12-week, randomized controlled trials evaluating the effects of cigarettes differing in nicotine dose (15.8, 2.4, or 0.4 mg/g) among individuals with affective disorders, opioid use disorder (OUD), and socioeconomically disadvantaged women. Linear mixed models tested differences by dose and time. Analyses first collapsed across populations and then separated out individuals with OUD because biomarkers suggested they used substantially more noncombusted nicotine. Across populations, weight increased significantly over time, averaging 1.03 kg (p < .001), but did not vary by dose nor was there any interaction of dose/time. "Increased appetite/hunger/weight gain" ratings increased significantly as a function of dose, with differences between low and high doses (1.95 and 1.73, respectively, p = .01), but not by time nor any interaction. In the combined group of individuals with affective disorders and socioeconomically disadvantaged women, weight and "increased appetite/hunger/weight gain" ratings increased significantly by dose, with differences between low and high doses (1.43 vs. 0.73 kg, p = .003 and 2.00 vs. 1.76, p = .02, respectively). Among individuals with OUD, there were no significant effects of any kind on either outcome. Individuals with affective disorders and socioeconomically disadvantaged women gained weight and reported more subjective appetite/weight gain when given 0.4, but not 2.4 mg/g cigarettes, despite comparable decreases in nicotine exposure. However, neither change was clinically significant, suggesting minimal short-term adverse consequences of a nicotine reduction policy. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Prevalence of psychosocial issues among pregnant women who do and do not use illicit substances.

OBJECTIVE: The American College of Obstetricians and Gynecologists (ACOG) recommends providers screen their prenatal patients for 11 psychosocial issues because they affect patient mental and physical well-being. The prevalence and co-occurrence of these issues have rarely been compared among pregnant women who do and do not report recent illicit substance use. METHOD: Seven psychosocial issues identified by ACOG were operationalized using National Survey on Drug Use and Health variables. We report weighted prevalence and adjusted risk ratios (ARR) for these issues in pregnant women who did versus did not report past-month illicit substance use. RESULTS: Pregnant women (n = 3,657) who reported past-month illicit substance use (6.3%; 95% CI [5.4-7.3]) had significantly higher prevalence of almost all psychosocial issues examined, including past-month cigarette smoking (44.9% versus 9.5%; ARR = 2.84, 95% CI [2.21-3.65]); past-month alcohol use, 36.1% versus 7.9%; ARR = 4.71 (3.59-6.18); serious past-month distress, 23.0% versus 5.0%; ARR = 3.51 (2.39-5.15); no health insurance, 11.7% versus 6.2%; ARR = 1.71 (1.07-2.74); and receipt of food stamps, 45.0% versus 24.0%; ARR = 1.40 (1.18-1.67). Moving 3 + times in the past year followed a similar pattern, but results were compatible with there being no difference, 10.6% versus 5.5%; ARR = 1.39 (0.86-2.25). The majority of pregnant women reporting illicit substance use endorsed experiencing ≥ 2 psychosocial issues while the majority of those who did not report illicit substance use did not endorse any. CONCLUSIONS: Pregnant women who use illicit substances experience higher prevalence and greater co-occurrence of psychosocial issues compared to those who do not, reinforcing recommendations for multidisciplinary approaches to care. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Reasons for past abortions among women in treatment for opioid use disorder.

OBJECTIVE: The main reasons women in the general population seek abortion are financial, timing, and partner-related reasons. While women with opioid use disorder (OUD) appear to use abortion services more than women in the general population, reasons for abortion in this group have not been examined to our knowledge. METHOD: Female patients aged 18-50 years in OUD treatment at 22 randomly selected facilities in Michigan were surveyed. The survey included items assessing reproductive health history. Women who reported having one or more abortions were asked to think back to that time and their reasons for choosing abortion. Twenty potential reasons and a write-in option were offered; women could endorse as many as applied. RESULTS: Of 260 women surveyed, 84 reported having an abortion. Of these, most (77.4%) reported multiple reasons for having an abortion. The most common reasons for having an abortion were not having money to take care of a baby (54.8%), feeling too young to have a child and not feeling ready to be a mother (both 42.9%), not loving the father and other partner-related concerns (25.0%-32.1%), and having concerns about the effects of their drug use (28.6%). No combination of reasons for abortion emerged as more prevalent than any other. CONCLUSIONS: Like women in the general population, women in treatment for OUD had not only abortions because of financial, timing, and partner-related reasons but also concerns about the effects of their drug use. These results underscore the multiple and often interrelated reasons that lead women to seek abortion. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Statewide Trends in Buprenorphine Prescribing in Rural and Nonrural Vermont: Analysis of Population-based Patient Pharmacy Claims.

IMPORTANCE: Opioid-related mortality rates have risen dramatically over the past decade, and office-based opioid treatment using buprenorphine offers hope for combatting this trend. Vermont's policymakers, health care systems, and treatment providers have worked to expand access to treatment throughout the rural state. OBJECTIVE: The objective of the current study was to characterize the trends in the number of buprenorphine prescribers and the number of patients per prescriber in Vermont over the past decade (2010-2020). METHODS: We used Vermont's all-payer claims database to identify patients with buprenorphine claims between 2010 and 2020 and their prescribers. We conducted analyses of trends in the number of prescribers treating different numbers of patients, the number of patients treated by prescribers in those categories, and the number of rural (vs nonrural) patients filling buprenorphine prescriptions. We used Z tests to determine if there were statistical differences between trends. RESULTS: The number of buprenorphine prescribers treating 10+ patients grew more rapidly than other prescriber groups ( P < 0.001). Nearly half of Vermont patients in 2020 were treated by 33 high-volume prescribers who treated 100 or more patients with buprenorphine. The number of patients filling buprenorphine prescriptions in Vermont increased by 98% between 2010 and 2020, with greater increases seen among rural than nonrural residents (107% vs 72%; P = 0.008). CONCLUSIONS AND RELEVANCE: Since 2010, Vermont has increased utilization of its office-based opioid treatment capacity, particularly in rural counties.

Technology-Assisted Buprenorphine Treatment in Rural and Nonrural Settings: Two Randomized Clinical Trials.

Importance: Expansion of opioid use disorder treatment is needed, particularly in rural communities. Objective: To evaluate technology-assisted buprenorphine (TAB) efficacy (1) over a longer period than previously examined, (2) with the addition of overdose education, and (3) among individuals residing in rural communities. Design, Setting, and Participants: Two parallel, 24-week randomized clinical trials were conducted at the University of Vermont between February 1, 2018, and June 30, 2022. Participants were adults with untreated opioid use disorder from nonrural (trial 1) or rural (trial 2) communities. These trials are part of a programmatic effort to develop TAB protocols to improve treatment availability in underserved areas. Interventions: Within each trial, 50 participants were randomized to TAB or control conditions. Participants in the TAB group completed bimonthly visits to ingest medication and receive take-home doses via a computerized device. They received nightly calls via an interactive voice response (IVR) system, IVR-generated random call-backs, and iPad-delivered HIV, hepatitis C virus (HCV), and overdose education. Control participants received community resource guides and assistance with contacting resources. All participants received harm reduction supplies and completed monthly assessments. Main Outcomes and Measures: The primary outcome was biochemically verified illicit opioid abstinence across monthly assessments. Secondary outcomes included self-reported opioid use in both groups and abstinence at bimonthly and random call-back visits, treatment adherence, satisfaction, and changes in HIV, HCV, and overdose knowledge among TAB participants. Results: Fifty individuals (mean [SD] age, 40.6 [13.1] years; 28 [56.0%] male) participated in trial 1, and 50 (mean [SD] age, 40.3 [10.8] years; 30 [60.0%] male) participated in trial 2. Participants in the TAB group achieved significantly greater illicit opioid abstinence vs controls at all time points in both trial 1 (85.3% [128 of 150]; 95% CI, 70.7%-93.3%; vs 24.0% [36 of 150]; 95% CI, 13.6%-38.8%) and trial 2 (88.0% [132 of 150]; 95% CI, 72.1%-95.4%; vs 21.3% [32 of 150]; 95% CI, 11.4%-36.5%). High abstinence rates were also observed at TAB participants' bimonthly dosing visits (83.0% [95% CI, 67.0%-92.0%] for trial 1 and 88.0% [95% CI, 71.0%-95.0%] for trial 2). Treatment adherence was favorable and similar between trials (with rates of approximately 99% for buprenorphine administration, 93% for daily IVR calls, and 92% for random call-backs), and 183 of 187 urine samples (97.9%) tested negative for illicit opioids at random call-backs. iPad-delivered education was associated with significant and sustained increases in HIV, HCV, and overdose knowledge. Conclusions and Relevance: In these randomized clinical trials of TAB treatment, demonstration of efficacy was extended to a longer duration than previously examined and to patients residing in rural communities. Trial Registration: ClinicalTrials.gov Identifier: NCT03420313.

Contingency management interventions for abstinence from cigarette smoking in pregnancy and postpartum: A systematic review and meta-analysis.

Contingency management is one of the most effective treatments for substance use disorders in not-pregnant people. The most recent quantitative review of its efficacy among pregnant and postpartum women who smoke cigarettes concluded with moderate certainty that those receiving contingent financial incentives were twice as likely to be abstinent compared with controls. We aimed to update and extend previous reviews. Five databases were systematically searched for randomized controlled trials (RCTs) published before December 2022 that assessed the effectiveness of incentives for abstinence from substance use. Data from trials of smoking abstinence were pooled using a random-effects meta-analysis model (restricted maximum likelihood). Results are reported as risk-ratios (RRs) with 95% confidence intervals (CIs). This study is registered with PROSPERO, CRD42022372291. Twelve RCTs (3136) pregnant women) were included. There was high certainty evidence that women receiving incentives were more likely to be abstinent than controls at the last antepartum assessment (12 RCTs; RR = 2.43, 95% CI 2.04-2.91, n = 2941, I2 = 0.0%) and moderate certainty evidence at the longest postpartum assessment while incentives were still available (five RCTs; RR = 2.72, 1.47-5.02, n = 659, I2 = 44.5%), and at the longest postpartum follow-up after incentives were discontinued (six RCTs; RR = 1.93, 1.08-3.46, n = 1753, I2 = 51.8%). Pregnant women receiving incentives are twice as likely to achieve smoking abstinence during pregnancy suggesting this intervention should be standard care for pregnant women who smoke. The results also demonstrate that abstinence continues into the postpartum period, including after incentives are discontinued, but more trials measuring outcomes in the postpartum period are needed to strengthen this conclusion.

US state laws relevant to incentives for health behavior: A qualitative analysis.

Contingency management (CM) involves provision of incentives for positive health behaviors via a well-defined protocol and is among the most effective treatments for patients with substance use disorders (SUDs). An understanding of laws affecting incentives for health behaviors and outcomes, including contexts in which incentives are already permitted, could inform efforts to disseminate CM. We conducted a systematic NexisUni legal database review of state statutes and regulations effective during 2022 to identify (a) laws that explicitly permit or prohibit delivery of incentives to patients, employees, or insurance beneficiaries for SUD-specific behaviors or outcomes, and (b) laws that explicitly permit delivery of incentives for any health behaviors or outcomes. We identified 27 laws across 17 jurisdictions that explicitly permit delivery of incentives for SUD-related behaviors or outcomes, with most occurring in the context of wellness programs. No state laws were identified that explicitly prohibit SUD-specific incentives. More broadly, we identified 57 laws across 29 jurisdictions permitting incentives for any health outcomes (both SUD- and non-SUD-related). These laws occurred in the contexts of wellness programs, K-12/early childhood education, government public health promotion, and SUD treatment provider licensing. Considering the urgent need to expand evidence-based SUD treatment in rural and underserved areas throughout the US, these findings could inform efforts to develop laws explicitly permitting provision of incentives in SUD care and enhance efforts to disseminate CM more broadly.

Prevalence of Psychosocial Issues Among Pregnant Women Who Do and Do Not Use Illicit Substances.

Objective It is often believed that pregnant women who use illicit substances are more likely to experience psychosocial issues like smoking, depression, and inadequate health care compared to pregnant women who do not. However, the prevalence of these psychosocial issues has rarely been calculated and compared using nationally representative data. Methods Important psychosocial issues identified by the American College of Obstetricians and Gynecologists were operationalized using variables in the National Survey on Drug Use and Health. We report weighted prevalence and age-adjusted odds ratios for these issues in pregnant women who did vs. did not report past-month illicit substance use. Results Pregnant women (n = 3,657) who reported past-month illicit substance use (6.3%; 95% CI 5.4-7.0) had significantly higher rates of almost all psychosocial issues examined, including past-month cigarette smoking (44.9% vs. 6.5%; age-adjusted odds ratio (AOR) = 7.14 (95% CI 4.98-10.20)); past-month alcohol use (36.1% vs. 7.8%; AOR = 6.80 (4.69, 9.86)); serious past-month distress (23.0% vs. 5.0%; AOR = 4.99 (3.07-8.11)); no health insurance (11.7% vs. 6.2%; AOR = 1.79 (1.07-2.99)); and receipt of food stamps (45.0% vs. 24.0%; AOR = 2.26 (1.55-3.29)). Moving 3 + times in the past year followed a similar pattern, but results were compatible with there being no difference between groups (10.6% vs. 5.5%; AOR = 1.59 (0.95-2.66)). In contrast to other issues examined, English language proficiency was higher among those who reported illicit substance use (4.7% vs. 0.4%; AOR = 0.08 (0.01-0.63)). Conclusions Pregnant women who use illicit substances experience higher rates of most psychosocial issues compared to those who do not, reinforcing recommendations for multidisciplinary approaches to care.

The Impact of the Covid-19 Pandemic on Smoking Among Vulnerable Populations.

AIM: While accumulating evidence suggests that people modified their smoking during the ongoing COVID-19 pandemic, it remains unclear whether those most at risk for tobacco-related health disparities did so. The current study examined changes in smoking among several vulnerable smoker populations during the COVID-19 pandemic. METHODS: A web-based survey was distributed in 2020 to 709 adults with socioeconomic disadvantage, affective disorders, or opioid use disorder who participated in a previous study investigating the effects of very low nicotine content (VLNC) cigarettes on smoking. Current smoking status and rate, and adoption of protective health behaviors in response to the pandemic (eg social distancing, mask wearing) were examined. RESULTS: Among 332 survey respondents (46.8% response rate), 84.6% were current smokers. Repeated measures ANOVA showed that current cigarettes/day (CPD) was higher during COVID than pre-COVID (12.9 ± 1.0 versus 11.6 ± 1.0; p < .001). Most respondents had adopted protective health behaviors to prevent infection (>79% for all behaviors). More than half indicated that they were still leaving their homes specifically to buy cigarettes (64.6%) and were buying more packs per visit to the store (54.5%) than pre-COVID. Individuals unemployed at the time of the survey experienced greater increases in CPD (from 11.4 ± 1.4 to 13.3 ± 1.4, p = .024) as did those with higher levels of anxiety (from 11.5 ± 1.1 to 13.6 ± 1.1, p < .001). CONCLUSIONS: Smoking increased during the COVID-19 pandemic in this sample of adults from vulnerable populations, even while most adopted protective health measures to prevent infection. Unemployment and anxiety might identify those at greatest risk for increases in tobacco use. IMPLICATIONS: Individuals from populations especially vulnerable to smoking might be at risk for greater harm from cigarette smoking during times of pandemic-related stress. Public health interventions are warranted to ameliorate increases in smoking among these populations. Special attention should be paid to those experiencing unemployment and high anxiety.

Relating individual differences in the reinforcing value of smoking and dependence severity to nicotine exposure levels in vulnerable populations.

Cigarette smoking is overrepresented in populations with psychiatric conditions and socioeconomic disadvantage. Greater understanding of the role of reinforcement and nicotine dependence in smoking among vulnerable populations may facilitate development of better targeted interventions to reduce smoking. Prior research demonstrated that individual differences in the reinforcing value of smoking and nicotine-dependence severity predicted total nicotine-exposure in vulnerable populations. The present study uses multivariate regression to address two aims: (1) Quantify the degree to which the reinforcing value of smoking, assessed using the Cigarette Purchase Task (CPT), and dependence severity assessed using the Fagerström Test of Nicotine Dependence and Brief Wisconsin Inventory of Smoking Dependence Motives (B-WISDM) each account for individual differences in cotinine-plus-3'-hydroxycotinine (COT+3HC) levels. (2) Explore whether there is overlap in the variance accounted for by the CTP, FTND, and B-WISDM. Participants were 628 adults with co-morbid psychiatric conditions or socioeconomic disadvantage who smoked daily. The CPT, FTND, and B-WISDM models accounted for 23.76%, 32.45%, and 29.61% of the variance in COT+3HC levels, respectively. Adding CPT to the FTND model failed to increase the variance accounted for and adding it to the B-WISDM model did so by only 1.2% demonstrating considerable overlap in the variance in nicotine exposure levels accounted for by these three instruments. These results provide new knowledge on the relationship between individual differences in the reinforcing value of smoking and nicotine-exposure levels and suggest differences in reinforcing value may underpin a considerable portion of the variance in nicotine exposure accounted for by dependence severity.

Potential effects of nicotine content in cigarettes on use of other substances.

A national nicotine reduction policy has the potential to reduce cigarette smoking and associated adverse health impacts among vulnerable populations. However, possible unanticipated adverse effects of reducing nicotine content in cigarettes, such as increasing the use of alcohol or other abused substances, must be examined. The purpose of this study was to evaluate the effects of exposure to varying doses of nicotine in cigarettes on use of other substances. This was a secondary analysis (n = 753) of three simultaneous, multisite, double-blind, randomized-controlled trials examining 12 weeks of exposure to study cigarettes varying in nicotine content (0.4, 2.4, 15.8 mg nicotine/g tobacco) among daily smokers from three vulnerable populations: individuals with affective disorders (n = 251), individuals with opioid use disorder (n = 256), and socioeconomically-disadvantaged women of reproductive age (n = 246). Effect of study cigarette assignment on urine toxicology screens (performed weekly) and responses to drug and alcohol use questionnaires (completed at study weeks 6 and 12) were examined using negative binomial regression, logistic regression, or repeated measures analysis of variance, controlling for sex, age, and menthol status. The most common substances identified using urine toxicology included tetrahydrocannabinol (THC; 44.8%), cocaine (9.2%), benzodiazepine (8.6%), and amphetamines (8.0%), with 57.2% of participants testing positive at least once for substance use (27.3% if excluding THC). No significant main effects of nicotine dose were found on any of the examined outcomes. These results suggest that reducing nicotine content does not systematically increase use of other substances, even among individuals at increased risk of substance use. ClinicalTrials.gov Identifiers: NCT02232737, NCT2250664, NCT2250534.

Leveraging the cigarette purchase task to understand relationships between cumulative vulnerabilities, the relative reinforcing effects of smoking, and response to reduced nicotine content cigarettes.

We examined if the relative-reinforcing effects of smoking increase with greater cumulative vulnerability and whether cumulative vulnerability moderates response to reduced nicotine content cigarettes. Participants were 775 adults from randomized clinical trials evaluating research cigarettes differing in nicotine content (0.4, 2.4, 15.8 mg/g). Participants were categorized as having low (0-1), moderate (2-3), or high (≥4) cumulative vulnerability. Vulnerabilities included rural residence, opioid use disorder, affective disorder, low educational attainment, poverty, unemployment, and physical disability. We used the cigarette purchase task (CPT) to assess the relative-reinforcing effects of participants' usual-brand cigarettes at baseline and study cigarettes during the 12-week trial. The CPT is a behavioral-economic task wherein participants estimate likely smoking (demand) over 24 h under escalating cigarette price. Demand is characterized by two factors: Amplitude (demand volume at zero/minimal price) and Persistence (demand sensitivity to price). Greater cumulative vulnerability was associated with greater demand Amplitude (F[2709] = 16.04,p < .0001) and Persistence (F[2709] = 8.35,p = .0003) for usual-brand cigarettes. Demand Amplitude for study cigarettes increased with increasing cumulative vulnerability (F[2619] = 19.59, p < .001) and decreased with decreasing nicotine content ([4879] = 5.45, p < .001). The only evidence of moderation was on demand Persistence (F[8867] = 2.00,p = .04), with larger reductions at the 0.4 mg/g compared to 15.8 mg/g doses among participants with low compared to moderate or high cumulative vulnerability. The relative-reinforcing effects of smoking clearly increase with greater cumulative vulnerability. Reducing nicotine content would likely reduce demand Amplitude across cumulative-vulnerability levels but reductions in demand Persistence may be more limited among those with greater cumulative vulnerability.

Randomized Controlled Trial Examining the Efficacy of Adding Financial Incentives to Best practices for Smoking Cessation Among pregnant and Newly postpartum Women.

We report results from a single-blinded randomized controlled trial examining financial incentives for smoking cessation among 249 pregnant and newly postpartum women. Participants included 169 women assigned to best practices (BP) or BP plus financial incentives (BP + FI) for smoking cessation available through 12-weeks postpartum. A third condition included 80 never-smokers (NS) sociodemographically-matched to women who smoked. Trial setting was Burlington, Vermont, USA, January, 2014 through January, 2020. Outcomes included 7-day point-prevalence abstinence antepartum and postpartum, and birth and other infant outcomes during 1st year of life. Reliability and external validity of results were assessed using pooled results from the current and four prior controlled trials coupled with data on maternal-smoking status and birth outcomes for all 2019 singleton live births in Vermont. Compared to BP, BP + FI significantly increased abstinence early- (AOR = 9.97; 95%CI, 3.32-29.93) and late-pregnancy (primary outcome, AOR = 5.61; 95%CI, 2.37-13.28) and through 12-weeks postpartum (AOR = 2.46; CI,1.05-5.75) although not 24- (AOR = 1.31; CI,0.54-3.17) or 48-weeks postpartum (AOR = 1.33; CI,0.55-3.25). There was a significant effect of trial condition on small-for-gestational-age (SGA) deliveries (χ2 [2] = 9.01, P = .01), with percent SGA deliveries (+SEM) greatest in BP, intermediate in BP + FI, and lowest in NS (17.65 + 4.13, 10.81 + 3.61, and 2.53 + 1.77, respectively). Reliability analyses supported the efficacy of financial incentives for increasing abstinence antepartum and postpartum and decreasing SGA deliveries; external-validity analyses supported relationships between antepartum cessation and SGA risk. Adding financial incentives to Best Practice increases smoking cessation among antepartum and postpartum women and improves other maternal-infant outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02210832.

Preliminary side effect profile, safety, and tolerability of hormonal contraception among women receiving opioid-agonist therapy.

OBJECTIVE(S): To characterize for the first time the side effect profile, safety, and tolerability of hormonal contraception among women receiving opioid-agonist therapy. STUDY DESIGN: We conducted a secondary analysis of data collected from participants in a three-arm randomized controlled trial (N = 138) aimed at increasing effective contraceptive use among women receiving opioid-agonist therapy. Participants in the 2 intervention conditions (n = 90) had free access to hormonal contraception at each of the 14 visits scheduled during the 6-month intervention. Contraceptive use and side effects were recorded at each visit; participants could change methods or discontinue use at any time. Verbatim side effects were classified using Medical Dictionary for Regulatory Activities (MedDRA) terminology. RESULTS: Of 67 participants reporting hormonal contraceptive use, 29 (43%) initiated implants, 14 (21%) intrauterine devices, 13 (19%) combined pills, 11 (16%) progestin-only pills, 10 (15%) injectables, 1 (2%) ring, and 1 (2%) patch; the average (±standard deviation) duration of use was 129 ± 55, 129 ± 60, 108 ± 62, 102 ± 61, 111 ± 31, 145, and 18 days, respectively. A total of 321 side effects were reported by 55 (82%) participants. Fifty (75%) participants reported menstrual cycle changes/uterine bleeding, followed by headaches (16, 24%), weight gain (15, 22%), and abdominal pain or nausea/vomiting (11, 16%). No serious side effects were reported. Twelve participants (18%) changed methods and 13 (19%) discontinued all hormonal contraceptive use. CONCLUSION(S): The hormonal contraceptive side effects reported by this small group of women receiving opioid-agonist therapy appear consistent with those reported by the general population, was generally well-tolerated, and did not raise safety concerns. IMPLICATIONS: These results provide important preliminary evidence that hormonal contraceptive use produces a familiar side effect profile and is well-tolerated by women receiving opioid-agonist therapy, although studies with larger samples followed over longer periods of time with appropriate comparison conditions are needed to fully assess tolerability and safety.

Effects of Reduced Nicotine Content Cigarettes on Fractional Exhaled Nitric Oxide and Self-Reported Respiratory Health Outcomes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage.

INTRODUCTION: This study examined whether exposure to reduced-nicotine-content cigarettes (RNCCs) for 12 weeks alters respiratory health using Fractional Exhaled Nitric Oxide (FeNO), a validated biomarker of respiratory epithelial health, and the Respiratory Health Questionnaire (RHQ), a subject-rated questionnaire on respiratory symptoms. Participants were 747 adult daily smokers enrolled in three double-blind, randomized clinical trials evaluating effects of cigarette nicotine content (0.4, 2.4, 15.8 mg nicotine/g tobacco) in people with affective disorders, opioid use disorder (OUD), or socioeconomic disadvantage. AIMS AND METHODS: FeNO levels and RHQ ratings were collected at baseline and Weeks 6 and 12 following randomization. Multiple regression was used to assess associations of FeNO and RHQ with smoking characteristics. Mixed-model repeated-measures ANOVA was used to evaluate the effects of nicotine content on FeNO and RHQ outcomes over the 12-week study period. RESULTS: FeNO levels but not RHQ ratings varied inversely with smoking characteristics at baseline (Ps < 0.0001) in smokers with affective disorders and socioeconomic disadvantage but less so in those with OUD. Participants with affective disorders and socioeconomic disadvantage, but not those with OUD, who were assigned to RNCCs had higher FeNO levels at Week 12 than those assigned to the 15.8 mg/g dose [F(2,423) = 4.51, p = .01, Cohen's d = 0.21]. No significant dose-related changes in RHQ scores were identified. CONCLUSIONS: Use of RNCCs across a 12-week period attenuates smoking-related reductions in FeNO levels in smokers with affective disorders and socioeconomic disadvantage although not those with OUD. FeNO changes were not accompanied by changes in respiratory-health ratings. TRIAL REGISTRATION: Inclusion and exclusion criteria for the sample and experimental manipulation of the nicotine content of assigned cigarettes are registered: NCT02232737, NCT02250664, NCT02250534. The FeNO measure reported in this manuscript is an exploratory outcome that was not registered. IMPLICATIONS: Should a reduced nicotine content standard be implemented; these results suggest that reduced nicotine content in cigarettes will not exacerbate and instead may attenuate smoking-related decreases in FeNO. This is significant as NO is an important component in maintaining a healthy respiratory system and necessary to defend against infection. Furthermore, the results of the current study demonstrate that the adoption of the reduced nicotine content standard may result in beneficial impacts on respiratory epithelial health among vulnerable populations that are disproportionally affected by the adverse health outcomes precipitated by combustible tobacco use.

Opioid use disorder treatment in rural settings: The primary care perspective.

Despite the efficacy of medications for treating opioid use disorder (OUD), they are underutilized, especially in rural areas. Our objectives were to determine the association between primary care practitioners (PCPs) rurality and concerns for patient substance use, and to identify factors associated with PCP comfort treating OUD, focusing on barriers to treatment. We developed a web-based survey completed by 116 adult-serving PCPs located in Vermont's rural and non-rural counties between April-August 2020. The instrument included PCP-identified concerns for substance use among patients, barriers to treating patients with OUD, and current level of comfort treating patients with OUD. On a scale from 0 to 10, rural PCPs reported higher concern for heroin (mean difference; Mdiff = 1.38, 95% CI: 0.13 to 2.63), fentanyl (Mdiff = 1.52, 95% CI: 0.29 to 2.74), and methamphetamine (Mdiff = 1.61, 95% CI: 0.33 to 2.90) use among patients compared to non-rural PCPs, and practitioners in both settings expressed high concern regarding their patients' use of tobacco (7.6 out of 10) and alcohol (7.0 out of 10). There was no difference in reported comfort in treating patients with OUD among rural vs. non-rural PCPs (Mdiff = 0.65, 95%CI: 0.17 to 1.46; P = 0.119), controlling for higher comfort among male PCPs and those waivered to prescribe buprenorphine (Ps < 0.05). Lack of training/experience and medication diversion were PCP-identified barriers associated with less comfort treating OUD patients, while time constraints was associated with more comfort (Ps < 0.05). Taken together, these data highlight important areas for dissemination of evidence-based training, support, and resources to expand OUD treatment capacity in rural communities.

Efficacy and Cost-Benefit of Onsite Contraceptive Services With and Without Incentives Among Women With Opioid Use Disorder at High Risk for Unintended Pregnancy: A Randomized Clinical Trial.

Importance: Rates of in utero opioid exposure continue to increase in the US. Nearly all of these pregnancies are unintended but there has been little intervention research addressing this growing and costly public health problem. Objective: To test the efficacy and cost-benefit of onsite contraceptive services with and without incentives to increase prescription contraceptive use among women with opioid use disorder (OUD) at high risk for unintended pregnancy compared with usual care. Design, Setting, and Participants: A randomized clinical trial of 138 women ages 20 to 44 years receiving medication for OUD who were at high risk for an unintended pregnancy at trial enrollment between May 2015 and September 2018. The final assessment was completed in September 2019. Data were analyzed from October 2019 to March 2021. Participants received contraceptive services at a clinic colocated with an opioid treatment program. Interventions: Participants were randomly assigned to receive 1 of 3 conditions: (1) usual care (ie, information about contraceptive methods and community health care facilities) (n = 48); (2) onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction (n = 48); or (3) those same onsite contraceptive services plus financial incentives for attending follow-up visits (n = 42). Main Outcomes and Measures: Verified prescription contraceptive use at 6 months with a cost-benefit analysis conducted from a societal perspective. Results: In this randomized clinical trial of 138 women (median age, 31 years [range, 20-44 years]), graded increases in verified prescription contraceptive use were seen in participants assigned to usual care (10.4%; 95% CI, 3.5%-22.7%) vs contraceptive services (29.2%; 95% CI, 17.0%-44.1%) vs contraceptive services plus incentives (54.8%; 95% CI, 38.7%-70.2%) at the 6-month end-of-treatment assessment (P < .001 for all comparisons). Those effects were sustained at the 12-month final assessment (usual care: 6.3%; 95% CI, 1.3%-17.2%; contraceptive services: 25.0%; 95% CI, 13.6%-39.6%; and contraceptive services plus incentives: 42.9%; 95% CI, 27.7%-59.0%; P < .001) and were associated with graded reductions in unintended pregnancy rates across the 12-month trial (usual care: 22.2%; 95% CI, 11.2%-37.1%; contraceptive services: 16.7%; 95% CI, 7.0%-31.4%; contraceptive services plus incentives: 4.9%; 95% CI, 0.6%-15.5%; P = .03). Each dollar invested yielded an estimated $5.59 (95% CI, $2.73-$7.91) in societal cost-benefits for contraceptive services vs usual care, $6.14 (95% CI, $3.57-$7.08) for contraceptive services plus incentives vs usual care and $6.96 (95% CI, $0.62-$10.09) for combining incentives with contraceptive services vs contraceptive services alone. Conclusions and Relevance: In this randomized clinical trial, outcomes with both onsite contraceptive service interventions exceeded those with usual care, but the most efficacious, cost-beneficial outcomes were achieved by combining contraceptive services with incentives. Colocating contraceptive services with opioid treatment programs offers an innovative, cost-effective strategy for preventing unintended pregnancy. Trial Registration: ClinicalTrials.gov Identifier: NCT02411357.