Society for Research on Nicotine and Tobacco as an Outgrowth of the 1988 Surgeon General's Report on Nicotine Addiction: Reflections of the Early Presidents.

INTRODUCTION: The Society for Research on Nicotine and Tobacco began in the United States as a scientific organization "to stimulate the generation and dissemination of new knowledge concerning nicotine and tobacco in all its manifestations." Now in its 30th year, the Society is taking on new challenges in tobacco control, nicotine vaping, product regulation, and public policy. AIMS AND METHODS: This Review describes the formative years of the Society from the perspective of researchers who were in leadership positions during that time, documenting how biobehavioral and clinical research in the first 10 years was a continuation of the scientific mission of the 1988 United States Surgeon General's Report on Nicotine Addiction and summarizing organizational innovations during each president's term of office. CONCLUSIONS: The Society's promotion of scientific research served as a catalyst for funding, policy, and regulation, setting the stage for its influence and credibility. IMPLICATIONS: This Commentary provides context and an overview of the scientific research and the organizational innovations that occurred during the early years of the Society for Research on Nicotine and Tobacco using publications and available documentation. The Society was able to thrive because biobehavioral research on nicotine addiction provided the scientific underpinnings for the tobacco control enterprise as a whole. The objective of this Commentary is to describe formative events in the Society's history based on the accomplishments of its early leaders.

Bupropion Slow Release vs Placebo With Adaptive Incentives for Cocaine Use Disorder in Persons Receiving Methadone for Opioid Use Disorder: A Randomized Clinical Trial.

Importance: Opioid-stimulant co-use is a common problem with few evidence-based treatments. Objective: To examine bupropion slow release (SR) enhancement of a tailored abstinence incentive program for stimulant use in persons with opioid use disorder. Design, Setting, and Participants: This 26-week, double-blind, placebo-controlled randomized clinical trial with a 4-week follow-up period was conducted at 4 methadone treatment programs in Baltimore, Maryland. Included participants were persons receiving methadone for the treatment of opioid use disorder with past 3-month cocaine use and current cocaine use disorder between March 2015 and September 2019. Data were analyzed from November 2020 through August 2022. Interventions: A 6-week incentive induction period with monetary incentives for evidence of cocaine abstinence during thrice-weekly urine testing was conducted. Persons achieving 2 weeks of consecutive abstinence during induction were assigned to the relapse prevention group (20 individuals); otherwise, individuals were assigned to the abstinence initiation group (60 individuals). Participants were randomized within incentive groups to bupropion SR (150 mg oral twice daily; 40 participants) or placebo (40 participants). Incentives were available until week 26, and study medication ended week 30. Main Outcomes and Measures: The mean percentage of participants with cocaine abstinence (by negative urinalysis or self-report) during weeks 7 to 26 (ie, the incentive intervention period) and 27 to 30 (ie, the follow-up period) and the percentage of participants testing negative for cocaine at weeks 26 and 30 were assessed. Main effects of medication collapsed across incentive conditions and sensitivity analyses of medications within incentive conditions were assessed. Analyses were conducted in the modified intention-to-treat sample (ie, 80 individuals who received ≥1 dose of study medication) and completers (ie, 52 individuals who completed ≥1 visit during week 30). Results: Among 80 participants (42 Black [52.5% ] and 35 White [43.8%]; mean [SD] age, 45.7 (9.4) years; 52 males [65.0%]) receiving methadone for opioid use disorder, 40 participants were randomized to receive bupropion SR and 40 participants to receive placebo. No significant difference on urinalysis or self-reported cocaine use was observed between medication groups. Sensitivity analyses revealed differential patterns for incentive subgroups. Participants in the relapse prevention group had high abstinence (>80%; eg, during weeks 7-26 in the modified intention-to-treat analysis, 410 of 456 samples [89.9%] from participants in the bupropion SR group tested negative for cocaine) throughout the trial regardless of whether they were randomized to bupropion SR or placebo. Participants in the abstinence initiation group had better outcomes with bupropion SR than placebo throughout the trial (mean [SD] total number of samples testing negative for cocaine, 30.3 [21.6] samples for bupropion SR vs 17.1 [14.9] samples for placebo; P = .05) and more participants receiving bupropion SR than placebo were abstinent at the end of the study (20 of 30 participants [66.7%] vs 9 of 30 participants [30.0%]; P = .04). Conclusions and Relevance: In this randomized clinical trial, an overall benefit for bupropion SR vs placebo when combined with a financial abstinence incentive program was not observed. Results among incentive subgroups suggest that continued evaluation of medications, including bupropion SR, for stimulant treatment using a tailored approach that factors early abstinence into study design and interpretation may be needed. Trial Registration: ClinicalTrials.gov Identifier: NCT02111798.

Tobacco use behaviors and views on engaging in clinical trials for tobacco cessation among individuals who experience homelessness.

Background: Clinical trials that include contingency management for smoking cessation have shown promising results for short-term quitting, but none have explored this approach for long-term abstinence in people experiencing homelessness. We designed a clinical trial of an extended contingency management intervention for smoking cessation for people experiencing homelessness. This study has two aims: (1) to explore tobacco use behaviors, and views toward smoking cessation, and (2) to explore factors influencing acceptability of engaging in such a trial in a sample of adult smokers experiencing homelessness. Methods: We administered a questionnaire to obtain information on tobacco use behaviors and conducted in-depth, semi-structured interviews with 26 patients who had experienced homelessness and were patients at a safety net health clinic in San Francisco, California, where we planned to pilot the intervention. We obtained information on triggers for tobacco use, prior cessation experiences, attitudes toward cessation, attitudes toward engaging in a clinical trial for cessation, and factors that might influence participation in our proposed contingency management clinical trial. We analyzed transcripts using content analysis. Results: Participants described the normative experiences of smoking, co-occurring substance use, and the use of tobacco to relieve stress as barriers to quitting. Despite these barriers, most participants had attempted to quit smoking and most were interested in engaging in a clinical trial as a method to quit smoking. Participants noted that desirable features of the trial include: receiving financial incentives to quit smoking, having a flexible visit schedule, having the study site be easily accessible, and having navigators with lived experiences of homelessness. Conclusion: A patient-centric clinical trial design that includes incentives, flexible visits and navigators from the community may increase feasibility of engaging in clinical trials among individuals experiencing homelessness.

Evaluation of real-world outcomes associated with use of a prescription digital therapeutic to treat substance use disorders.

BACKGROUND AND OBJECTIVES: Digital therapeutics can expand the reach and fidelity of behavioral treatment for substance use disorders (SUDs). This analysis evaluated real-world engagement and clinical outcomes in patients diagnosed with SUD who were prescribed reSET®, an FDA-authorized prescription digital therapeutic (PDT). METHODS: Patients were prescribed a 12-week PDT comprising 61 therapy lessons (31 "core" and 30 "keep learning" lessons) and contingency management rewards (positive reinforcement message or monetary gift cards) based on lesson completion and negative urine drug screens. Engagement (defined as any activity in the PDT), retention (any activity in Weeks 9-12), and substance use data were collected automatically by the PDT and analyzed descriptively. Associations between early lesson completion and end-of-treatment outcomes were assessed. RESULTS: Six hundred and fifty-eight patients filled their prescription. Evaluated were 602 patients who were exposed to therapeutic content by completing at least one lesson (median age 37 years, 33% female, 41% male, 26% unreported sex). Median lessons completed was 33 (out of 61 possible), and 52% of patients completed all core modules. Retention in treatment during the last 4 weeks of treatment was 74%, and 62% were abstinent (missing data considered positive). [Correction added on 13 December 2022, after first online publication: In the preceding sentence, the treatment percentage values were revised from 74.6% to 74%.] DISCUSSION AND CONCLUSIONS: Patients with SUD exhibited robust engagement with a PDT, high rates of retention through 12 weeks, and substantial rates of abstinence at end of treatment when the therapeutic was used in a real-world setting. PDT's hold promise as a new way to access effective SUD treatment. SCIENTIFIC SIGNIFICANCE: This study is the first to report real-world PDT engagement and clinical outcomes data from a large, geographically diverse population of patients with SUDs.

Contingency management to promote smoking cessation in people experiencing homelessness: Leveraging the electronic health record in a pilot, pragmatic randomized controlled trial.

BACKGROUND: Cigarette smoking is disproportionately high among people experiencing homelessness (PEH). Contingency management (CM) is a strategy that has shown considerable efficacy for smoking cessation and has been used in short-term studies of smoking abstinence in PEH. We describe a pilot, pragmatic randomized controlled trial protocol, which leverages an electronic health record (EHR) infrastructure to assess the feasibility and acceptability of an extended CM intervention to improve long-term abstinence in PEH. METHODS: We will conduct the study at three safety-net clinics in San Francisco among 90 adults experiencing homelessness who smoke cigarettes currently and have a desire to quit. We will encourage all participants to receive smoking cessation services that include behavioral counseling and pharmacotherapy through their clinics. We will randomly assign participants to an extended CM intervention group with escalating incentives contingent on abstinence or to a control group with fixed incentives for attending study visits. We will use the EHR to recruit participants, track receipt of counseling and pharmacotherapy during clinical care, and communicate with providers on participants' progress. CM participants will get escalating incentives for demonstration of carbon monoxide-verified abstinence over 6 months, with a total possible earnings of $475. Control participants will receive a fixed incentive of $5 for attending study visits, totaling $125. We will conduct the carbon-monoxide verified abstinence assessments-which will determine CM incentive amounts-daily during week 1, bi-weekly through week 4, weekly through week 13, and monthly through week 24. Measures of feasibility and acceptability, both quantitative and qualitative, will include assessments of screening and recruitment, adherence to study visits, engagement in smoking cessation clinical care, retention, and participant satisfaction. One of the primary clinical outcomes will be biochemically verified 7-day point prevalence abstinence at 6 months. We will measure secondary outcomes, which will include 7-day point prevalence abstinence at 2 weeks, 3 and 12 months. DISCUSSION: This trial will allow us to assess the feasibility and acceptability of a CM cessation intervention among PEH. The protocol's clinical setting and use of EHRs gives it significant potential for scalability. If found to be feasible, acceptable, and subsequently efficacious in a larger trial, the intervention could reduce tobacco-related health disparities by increasing long-term smoking abstinence among this vulnerable population. TRIAL REGISTRATION: ClinicalTrials.gov NCT04982952. Registered on July 29, 2021.

Practical Technology for Expanding and Improving Substance Use Disorder Treatment: Telehealth, Remote Monitoring, and Digital Health Interventions.

The US opioid crisis and the COVID-19 pandemic have sparked innovation in substance use disorder (SUD) treatment such that telehealth, remote monitoring, and digital health interventions are increasingly feasible and effective. These technologies can increase SUD treatment access and acceptability, even for nontreatment seeking, remote, and underserved populations, and can be used to reduce health disparities. Overall, digital tools will likely overcome many barriers to delivery of evidence-based behavioral treatments such as cognitive behavioral therapy and contingency management, that, along with appropriate medications, constitute the foundation of treatment of SUDs.

Factors related to substance use treatment attendance after peer recovery coach intervention in the emergency department.

Introduction: Brief intervention with peer recovery coach support has been used to generate referrals to substance use disorder treatment from the emergency department (ED). This retrospective study evaluated factors associated with successful linkage to treatment following brief intervention in the ED. Methods: Data were extracted from the electronic health record for patients who were referred to substance use treatment from the ED and for whom follow-up data regarding treatment attendance was available (n=666). We examined associations between demographic and insurance variables, substance use, mental health diagnosis, prior abstinence, and stage of change with successful linkage to substance use treatment after ED referral. Results: The sample was majority male (68%), White (62%), and had a mean age of 43 years (SD=12). Medicaid was the most common insurance (49%) followed by employer/private (34%). Multivariable logistic regression determined patients with Medicaid (OR=2.94, 95% CI:2.09-4.13, p=<.001), those who had a documented alcohol use disorder diagnosis (OR=1.59, 95% CI:1.074-2.342, p=.02), and those in the "Action" stage of change (OR=2.33, 95% CI:1.47-3.69, p=<.001) had greater odds of being successfully linked to treatment. Conclusions: These results identify characteristics of patients available in the health record to determine who is more likely or less likely to attend substance use treatment following ED referral. Given appropriate screening, this information could be used to direct standard care resources to those with high likelihood of treatment attendance and strengthen follow-up interventions with peer recovery coaches for those with lower likelihood of treatment attendance.

Digital delivery of a contingency management intervention for substance use disorder: A feasibility study with DynamiCare Health.

Digital health tools can provide convenient delivery of evidence-based treatments. The DynamiCare Health smartphone app delivers a contingency management intervention for substance use disorder consisting of remote self-testing for alcohol (breath) and drugs (saliva) with remote test validation and delivery of financial incentives for negative test results. This study examined feasibility, engagement (duration and consistency of app utilization), and impact on usual care treatment participation when a community substance use treatment program implemented this digital therapy among its patients. The study randomly assigned patients with alcohol use disorder (N = 61) to receive either DynamiCare along with treatment-as-usual (TAU; N = 29) or TAU only (N = 32) during a 90-day evaluation period. Mean duration between first and last app use was 64 (±35) days, with mean earnings of $248 (±$209, out of $600 maximum). Among those with any app use (n = 25), compliance was 68% and 74%, respectively for requested breath and saliva samples. Overall, two thirds of patients (66%) assigned to the app used it for at least 57 days and with high rates of self-testing compliance. Those completing the assessment (n = 13; 45% of sample) endorsed high satisfaction ratings. DynamiCare versus TAU participants were more likely to be retained in usual care treatment at 90 days (24% vs 3%; (χ2 (1, 61) = 5.9, p < 0.05), but sustained app utilization was associated with a wide range of usual care treatment participation. These data suggest that DynamiCare Health is feasible and potentially beneficial as a complement to community substance use treatment programs.

Self-efficacy as a mediator of patient navigation interventions to engage persons living with HIV and substance use.

BACKGROUND: People living with HIV who report substance use (PLWH-SU) face many barriers to care, resulting in an increased risk for poor health outcomes and the potential for ongoing disease transmission. This study evaluates the mechanisms by which Patient Navigation (PN) and Contingency Management (CM) interventions may work to address barriers to care and improve HIV outcomes in this population. METHODS: Mediation analysis was conducted using data from a randomized, multi-site trial testing PN interventions to improve HIV care outcomes among 801 hospitalized PLHW-SU. Direct and indirect effects of PN and PN + CM were evaluated through five potential mediators-psychosocial conditions, healthcare avoidance, financial hardship, system barriers, and self-efficacy for HIV treatment adherence-on engagement in HIV care and viral suppression. RESULTS: The PN + CM intervention had an indirect effect on improving engagement in HIV care at 6 months by increasing self-efficacy for HIV treatment adherence (ß = 0.042, 95% CI = 0.008, 0.086). PN + CM also led to increases in viral suppression at 6 months (ß = 0.090, 95% CI = 0.023, 0.168) and 12 months (ß = 0.069, 95% CI = 0.009, 0.129) via increases in self-efficacy, although the direct effects were not significant. No mediating effects were observed for PN alone. CONCLUSION: PN + CM interventions for PLWH-SU can increase an individual's self-efficacy for HIV treatment adherence, which in turn improves engagement in care at 6 months and may contribute to viral suppression over 12 months. Building self-efficacy may be a key factor in the success of such interventions and should be considered as a primary goal of PN + CM in practice.

An alternative analysis of illicit opioid use during treatment in a randomized trial of extended-release naltrexone versus buprenorphine-naloxone: A per-protocol and completers analysis.

BACKGROUND: The distinct pharmacological properties and clinical uses of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) present challenges in analyzing patient outcomes. METHODS: We conducted a secondary analysis of a multi-site randomized trial comparing XR-NTX with sublingual BUP-NX treatment for opioid use disorder initiated during inpatient detoxification and continued in outpatient treatment. Urine testing data for non-study opioids from the last 22 weeks of the 24-week trial were analyzed in both a per-protocol sample (n = 474 participants who received at least one dose of medication) and a completers sample (n = 211 participants who received all XR-NTX doses or all BUP-NX prescriptions). The present analyses sought to identify differences in the weekly percentages of opioid-positive urine tests between participants treated with the two medications. RESULTS: The proportion of opioid-positive tests in both conditions was less than 20 % for 21 of the 22 weeks in the per-protocol sample and all 22 weeks in the completers sample. Generalized linear mixed model analyses revealed a significant treatment (XR-NTX vs. BUP-NX) X week (weeks 3-24) interaction in the per-protocol sample but not the completers sample. In the per-protocol analysis, the BUP-NX, compared to XR-NTX, had significantly greater proportions of opioid-positive tests in 14 out of the 22 weeks. CONCLUSIONS: Longitudinal modeling approaches that utilize flexible procedures for handling missing data can offer a different perspective on study findings. Results from the present analyses suggest that XR-NTX appeared to be somewhat more effective than BUP-NX in reducing illicit opioid use in the per-protocol sample.

A Randomized and Controlled Acceptability Trial of an Internet-based Therapy among Inpatients with Co-occurring Substance Use and Other Psychiatric Disorders.

OBJECTIVES: Technology-assisted treatment (TAT) holds promise for innovative assessment, prevention, and treatment of substance use disorders (SUD). The widespread access to TAT makes it a potentially cost-effective and inventive option available for delivery in multiple settings. This study assessed acceptability of the web-based Therapeutic Education System (TES) in hospitalized dual diagnosis patients with SUDs and other psychiatric disorders. Methods: Eligible participants were nonpsychotic, voluntary patients with self-reported drug or alcohol use in the 30 days prior to admission. They were randomly assigned to treatment as usual (TAU, n = 47) or TAU + TES (n = 48). Acceptability of this Internet-based intervention was assessed by observed utilization and self-report. Results: The TAU + TES group (# analyzed = 41) completed a mean total of 5.5 (SEM = 0.8) modules with about one module per day while hospitalized and rated TES highly on several constructs of acceptability, including novelty, usefulness and ease of understanding. Conclusions: These findings support further exploration of TAT for treatment expansion in a high acuity, dual diagnosis population and indicate the value of future research on efficacy. ClinicalTrials.gov Identifier: NCT02674477.

Investigating tobacco withdrawal in response to reduced nicotine cigarettes among smokers with opioid use disorder and other vulnerabilities.

Individuals with opioid use disorder (OUD) have high prevalence of smoking and poor cessation outcomes. Data suggest that smokers with OUD may experience heightened nicotine reinforcement and more severe tobacco withdrawal compared to smokers without OUD. The Food and Drug Administration is currently considering reducing the nicotine content of cigarettes to reduce smoking prevalence and smoking-related disease. It is critical to understand the effects of reduced nicotine content cigarettes (RNCCs) on tobacco withdrawal in this subgroup. In this secondary analysis, we investigated the ability of RNCCs to attenuate acute tobacco withdrawal and craving severity in smokers with OUD versus those without substance use disorders (SUDs). Smokers maintained on methadone or buprenorphine (opioid-maintained [OM]; n = 65) versus without other SUDs (i.e., non-SUD; n = 135) completed 5 laboratory sessions wherein they smoked their usual brand (UB) or a research cigarette varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g of tobacco) under double-blind, acute abstinence conditions. Participants completed the Minnesota Tobacco Withdrawal Scale, including a desire to smoke (craving) item, before and every 15 min for 1 hr following smoking each cigarette. Tobacco withdrawal and craving did not differ significantly by OM status in response to UB or RNCCs. In addition to the Dose × Time interaction, greater depression and cigarette dependence consistently predicted withdrawal and craving (ps < .05). Across all cigarettes, tobacco withdrawal and craving did not significantly differ by OM status, suggesting that smokers receiving opioid agonist treatment may respond favorably to RNCCs. Additional studies with larger and more diverse samples are needed to address this question more definitively. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Potential Moderating Effects of Sex/Gender on the Acute Relative Reinforcing and Subjective Effects of Reduced Nicotine Content Cigarettes in Vulnerable Populations.

INTRODUCTION: Reports in relatively healthy smokers suggest men are more sensitive than women to the subjective effects of reduced nicotine content cigarettes (RNCCs). We know of no reports examining sex differences in the relative reinforcing effects of RNCCs, an important outcome in assessing smoking's addiction potential. The aim of the present study is to address this gap by examining sex/gender differences on reinforcing effects while examining whether sex differences in subjective effects are discernible in vulnerable populations. METHODS: Secondary analysis of a within-subject, double-blinded experiment examining acute effects of cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g) among 169 adult smokers with psychiatric conditions or socioeconomic disadvantage. Effects of dose, sex, and their interaction were examined on reinforcing (concurrent-choice and Cigarette Purchase Task [CPT] testing), and subjective effects (Cigarette Evaluation Questionnaire [CEQ] and craving/withdrawal ratings). RESULTS: Reducing nicotine content decreased the relative reinforcing effects of smoking in concurrent-choice and CPT testing (p's < .05) with no significant effects of sex nor dose × sex/gender interactions. Reducing nicotine content decreased CEQ ratings with only a single significant effect of sex (higher Psychological Reward scores among women than men, p = .02) and no significant dose × sex/gender interactions. Results on craving/withdrawal paralleled those on the CEQ. CONCLUSIONS: Reducing nicotine content decreases the addiction potential of smoking independent of sex in populations highly vulnerable to smoking and addiction, with no indication that women are less sensitive to subjective effects of RNCCs or would benefit less from a policy reducing the nicotine content of cigarettes. IMPLICATIONS: A policy reducing the nicotine content of cigarettes has the potential to reduce the addiction potential of smoking across men and women who are especially vulnerable to smoking, addiction, and tobacco-related adverse health impacts.

Enhancing patient navigation with contingent financial incentives for substance use abatement in persons with HIV and substance use.

Substance use can interfere with HIV treatment. A previous multisite clinical trial (Metsch et al., 2016) tested 2 behavioral interventions designed to improve treatment engagement in people with comorbid HIV and drug or heavy alcohol use. Clinical trial participants were randomized to treatment as usual (N = 264), patient navigation (PN; N = 266), or PN with contingency management (PN + CM; N = 271) for 6 months. PN + CM patients could earn financial incentives both for entering substance use disorder (SUD) treatment and for submitting urine and breath samples negative for opioids, stimulants, and alcohol. This secondary analysis compared frequencies of treatment entry and sample submission in the PN versus PN + CM groups and examined associations with viral suppression (defined as ≤200 copies/mL). Incentives were associated with a higher percentage of patients entering SUD treatment (PN = 25.5%; PN + CM = 47.6%; p < .001), a higher percentage submitting samples for drug testing (PN median = 2, interquartile range [IQR] = 0.5; PN + CM median = 8, IQR = 5.1; p < .0001) and a higher percentage submitting samples negative for targeted drugs and alcohol (PN median = 1, IQR = 0.3; PN + CM median = 6, IQR = 2.9; p < .0001). Within the PN + CM group, up to 58% of those with high rates of engagement in activities were virally suppressed at 6 months versus 24-29% in subgroups with lowest engagement. In conclusion, CM was feasibly incorporated into PN for persons with HIV and SUD and was associated with higher rates of engagement in targeted substance use abatement activities. CM has the potential to improve health outcomes in this population. (PsycINFO Database Record (c) 2020 APA, all rights reserved).

Potential Moderating Effects of Psychiatric Diagnosis and Symptom Severity on Subjective and Behavioral Responses to Reduced Nicotine Content Cigarettes.

INTRODUCTION: Given FDA's authority to implement a cigarette nicotine reduction policy, possible outcomes of this regulation must be examined, especially among those who may be most affected, such as those with comorbid psychiatric disorders. METHODS: In this secondary analysis of a multisite, randomized, clinical laboratory study, we used analyses of variance to examine the effects of nicotine dose (0.4, 2.4, 5.2, and 15.8 mg/g of tobacco), depressive and anxiety diagnoses (depression only, anxiety only, both, or neither), and depressive and anxiety symptom severity on cigarette choice, smoke exposure, craving, and withdrawal across three vulnerable populations: socioeconomically disadvantaged women of reproductive age, opioid-dependent individuals, and those with affective disorders (n = 169). RESULTS: Diagnosis and symptom severity largely had no effects on smoking choice, total puff volume, or CO boost. Significant main effects on craving and withdrawal were observed, with higher scores in those with both anxiety and depression diagnoses compared with depression alone or no diagnosis, and in those with more severe depressive symptoms (p's < .001). These factors did not interact with nicotine dose. Cigarettes with <15.8 mg/g nicotine were less reinforcing, decreased total puff volume, and produced significant but lower magnitude and shorter duration reductions in craving and withdrawal than higher doses (p's < .01). CONCLUSIONS: Reducing nicotine dose reduced measures of cigarette addiction potential, with little evidence of moderation by either psychiatric diagnosis or symptom severity, providing evidence that those with comorbid psychiatric disorders would respond to a nicotine reduction policy similarly to other smokers. IMPLICATIONS: Thus far, controlled studies in healthy populations of smokers have demonstrated that use of very low nicotine content cigarettes reduces cigarette use and dependence without resulting in compensatory smoking. These analyses extend those findings to a vulnerable population of interest, those with comorbid psychiatric disorders. Cigarettes with very low nicotine content were less reinforcing, decreased total puff volume, and produced significant but lower magnitude and shorter duration reductions in craving and withdrawal than higher doses. These nicotine dose effects did not interact with psychiatric diagnosis or mood symptom severity suggesting that smokers in this vulnerable population would respond to a nicotine reduction strategy similarly to other smokers.

Examining effects of unit price on preference for reduced nicotine content cigarettes and smoking rate.

Cigarette preference increases as a function of greater nicotine content, but manipulating cost can shift preference. The aims of the present study are to model whether (1) the behavioral-economic metric unit price (cost/reinforcer magnitude) accounts for preference shifts and (2) whether preference shifts toward reduced nicotine content are associated with smoking reductions. In a multisite study between 2015 and 2016, 169 daily smokers from vulnerable populations completed two concurrent-choice conditions examining preference for smoking normal (15.8 mg/g) and reduced (0.4 mg/g) nicotine content cigarettes. In Condition 1, both products were available at 10 responses/choice. In Condition 2, availability of the 0.4 mg/g dose remained at 10 responses/choice while the 15.8 mg/g dose was available on a progressive-ratio (PR) schedule wherein response cost increased following each choice. Unit prices were calculated by dividing dose by response requirement. Results were analyzed using ANOVA and binomial tests (p < .05). Participants preferred the 15.8 over 0.4 mg/g dose in Condition 1, but shifted preference to the 0.4 mg/g dose in Condition 2 (p < .001) immediately before the point in the PR progression where unit price for 15.8 dose exceeded unit price for the 0.4 dose (p < .001). This shift was associated with a reduction in smoking (p < .001). The unit price of nicotine appears to underpin cigarette product preference and may provide a metric for predicting preference and potentially impacting it through tobacco regulations. These results also demonstrate that reduced compared to normal nicotine content cigarettes sustain lower smoking rates discernible even under acute laboratory conditions and in vulnerable populations.

Evaluating the utility of the modified cigarette evaluation questionnaire and cigarette purchase task for predicting acute relative reinforcing efficacy of cigarettes varying in nicotine content.

BACKGROUND: Nicotine is the addictive component in cigarettes that maintain cigarette smoking that subsequently leads to morbidity and mortality. Methods for assessing the abuse liability of cigarettes are essential to inform new tobacco product standards. This secondary analysis evaluated the utility of one subjective effects measure, the modified Cigarette Evaluation Questionnaire (mCEQ), and one behavioral economic task, the Cigarette Purchase Task (CPT), for predicting acute relative reinforcing efficacy measured by concurrent choice Self-Administration (SA). METHODS: Smokers (N = 169) belonging to one of three vulnerable populations participated in a multi-site, double-blind study evaluating research cigarettes with varying levels of nicotine (0.4, 2.4, 5.2, 15.8 mg/g). Participants sampled cigarettes and completed the mCEQ and CPT. In subsequent sessions, cigarette preference was assessed using a concurrent choice SA procedure. Mixed-model repeated measures analysis of variance tests were used to evaluate the utility of the mCEQ subscales and CPT indices for predicting preference for the higher compared to lower nicotine content cigarettes. In addition, stepwise regressions were used to determine which subscales and indices independently predicted concurrent choice SA. RESULTS: Greater increases on the Satisfaction and Enjoyment of Respiratory Tract Sensations mCEQ subscales independently predicted higher dose preference in concurrent choice testing. Elasticity was the only CPT index that predicted choice. However, its predictive utility differed by dose among opioid-maintained individuals. CONCLUSION: The mCEQ and CPT predict behavioral measures of relative reinforcing efficacy as assessed in concurrent choice SA, with the mCEQ Satisfaction and Enjoyment of Respiratory Tract Sensations subscales being the strongest independent predictors.

Response to Reduced Nicotine Content in Vulnerable Populations: Effect of Menthol Status.

OBJECTIVES: In this study, we investigated potential effects of being a menthol smoker on response to reduced nicotine content (RNC) cigarettes in smokers especially vulnerable to smoking. METHOD: Participants were 169 smokers (61 menthol and 108 non-menthol smokers) with comorbid mental illness, substance use disorder, or socioeconomic disadvantage. Participants completed a double-blind study assessing addiction potential, withdrawal/craving, and compensatory smoking across 4 research cigarettes varying in nicotine content from very low levels to commercial levels (0.4, 2.4, 5.2, 15.8mg/g of tobacco). Repeated measures analysis of variance was used to examine potential moderating effects of menthol status. RESULTS: Statistically significant effects of nicotine dose were noted across measures, with higher doses producing greater economic demand and relief from withdrawal/craving. The relationships between nicotine dose and response to RNC cigarettes do not differ by menthol status. CONCLUSIONS: Results of this study suggest menthol does not have a differential impact on response to RNC cigarettes across measures of economic demand, withdrawal/craving, or smoking topography. These results suggest that any potential beneficial effects of RNC cigarettes should extend to menthol smokers including those especially vulnerable to smoking.

Response to reduced nicotine content cigarettes among smokers with chronic health conditions.

Individuals with chronic health conditions persist in smoking despite the presence of smoking-related illness. The aim of this study was to examine whether chronic health conditions moderate response to reduced nicotine content cigarettes (0.4, 2.4, 5.2, 15.8 mg/g of tobacco). This is a secondary analysis of a controlled clinical laboratory study that examined the acute effects of cigarettes varying in nicotine content among individuals especially vulnerable to smoking and tobacco dependence. Participants in the present study were categorized as having 0, 1-2, or ≥3 smoking-related chronic health conditions (i.e., chronic condition severity, CCS). Repeated-measures analysis of variance was used to examine whether CCS moderated response to cigarettes across measures of addiction potential (i.e., concurrent choice testing between nicotine dose pairs, Cigarette Purchase Task (CPT) performance, positive subjective effects), tobacco withdrawal, cigarette craving, and smoking topography. No main effects of CCS or interactions of CCS and nicotine dose were observed for concurrent choice testing, positive subjective effects, tobacco withdrawal, or smoking topography. Main effects of CCS were noted on the CPT with greater CCS being associated with less persistent demand. There was an interaction of CCS and nicotine dose on Factor 1 of the Questionnaire on Smoking Urges with the effects of dose significant only among those with 1-2 chronic conditions. Overall, we see minimal evidence that chronic condition severity affects response to reduced nicotine content cigarettes. A policy that reduces the nicotine content of cigarettes to minimally addictive levels may benefit smokers already experiencing smoking-related chronic conditions.

How patient navigators view the use of financial incentives to influence study involvement, substance use, and HIV treatment.

BACKGROUND AND AIMS: While patient navigation has been shown to be an effective approach for linking persons to HIV care, and contingency management is effective at improving substance use-related outcomes, Project HOPE combined these two interventions in a novel way to engage HIV-positive patients with HIV and substance use treatment. The aims of this paper are to examine patient navigator views regarding how contingency management interacted with and affected their navigation process. DESIGN: Semi-structured qualitative interviews. PARTICIPANTS: 22 patient navigators from the original 10 Project HOPE study sites. MEASUREMENTS: Individual, semi-structured interviews lasting approximately 60 min addressed the patient navigator's professional background, descriptions of the participant population, substance use disorder versus HIV treatment entry and engagement issues, and the use of contingency management within the navigation service delivery protocol. FINDINGS: Patient navigators believed that financial incentives helped motivate participant attendance at navigation sessions, particularly early in study involvement, which helped them to establish rapport and develop relationships with participants. Patient navigators often noted that financial incentives positively influenced targeted HIV health-related behaviors, such as attending medical appointments, which provided a rapid pay-off with an escalating sum. Contingency management was more complex when used by the patient navigators for substance use-related behaviors, particularly when incentives revolved around negative urine screening. Patient navigators noted that not all participants responded the same way to the contingency management and that the incentives were particularly helpful when participants were financially strained with limited resources or when internal motivation was lacking. CONCLUSIONS: Overall patient navigators found the inclusion of contingency management to be helpful and affective at influencing participant behaviors, particularly concerning navigation session attendance and HIV healthcare-related participation. However, issues and concerns surrounding the inclusion of contingency management for drug-related behaviors as delivered in Project HOPE were noted. CLINICAL TRIALS REGISTRATION: NCT01612169.