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.

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.

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.

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.

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.

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.

Randomized Trial of Reduced-Nicotine Standards for Cigarettes.

BACKGROUND: The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes. METHODS: We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6. RESULTS: A total of 840 participants underwent randomization, and 780 completed the 6-week study. During week 6, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes, respectively) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram (22.2 and 21.3 cigarettes, respectively; P<0.001). Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day, which did not differ significantly from the average number among those who smoked control cigarettes. Cigarettes with lower nicotine content, as compared with control cigarettes, reduced exposure to and dependence on nicotine, as well as craving during abstinence from smoking, without significantly increasing the expired carbon monoxide level or total puff volume, suggesting minimal compensation. Adverse events were generally mild and similar among groups. CONCLUSIONS: In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products; ClinicalTrials.gov number, NCT01681875.).

Response to reduced nicotine content cigarettes among smokers differing in tobacco dependence severity.

This study examines whether tobacco dependence severity moderates the acute effects of reducing nicotine content in cigarettes on the addiction potential of smoking, craving/withdrawal, or smoking topography. Participants (N = 169) were daily smokers with mild, moderate, or high tobacco-dependence severity using the Heaviness of Smoking Index. Following brief abstinence, participants smoked research cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg nicotine/g tobacco) in a within-subject design. Results were analyzed using repeated measures analysis of co-variance. No main effects of dependence severity or interactions with nicotine dose were noted in relative reinforcing effects in concurrent choice testing or subjective effects on the modified Cigarette Evaluation Questionnaire. Demand for smoking in the Cigarette Purchase Task was greater among more dependent smokers, but reducing nicotine content decreased demand independent of dependence severity. Dependence severity did not significantly alter response to reduced nicotine content cigarettes on the Minnesota Tobacco Withdrawal Scale nor Questionnaire of Smoking Urges-brief (QSU) Factor-2 scale; dependence severity and dose interacted significantly on the QSU-brief Factor-1 scale, with reductions dependent on dose among highly but not mildly or moderately dependent smokers. Dependence severity and dose interacted significantly on only one of six measures of smoking topography (i.e., maximum flow rate), which increased as dose increased among mildly and moderately but not highly dependent smokers. These results suggest that dependence severity has no moderating influence on the ability of reduced nicotine content cigarettes to lower the addiction potential of smoking, and minimal effects on relief from craving/withdrawal or smoking topography.

Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial.

IMPORTANCE: Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates. OBJECTIVE: To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients. DESIGN, SETTING, AND PARTICIPANTS: From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months. INTERVENTIONS: Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment. MAIN OUTCOMES AND MEASURES: The primary outcome was HIV viral suppression (≤200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up. RESULTS: Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68). CONCLUSIONS AND RELEVANCE: Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01612169.

The Use of Technology in Participant Tracking and Study Retention: Lessons Learned From a Clinical Trials Network Study.

BACKGROUND: The growing use of newer communication and Internet technologies, even among low-income and transient populations, require research staff to update their outreach strategies to ensure high follow-up and participant retention rates. This paper presents the views of research assistants on the use of cell phones and the Internet to track participants in a multisite randomized trial of substance use disorder treatment. METHODS: Preinterview questionnaires exploring tracking and other study-related activities were collected from 21 research staff across the 10 participating US sites. Data were then used to construct a semistructured interview guide that, in turn, was used to interview 12 of the same staff members. The questionnaires and interview data were entered in Atlas.ti and analyzed for emergent themes related to the use of technology for participant-tracking purposes. RESULTS: Study staff reported that most participants had cell phones, despite having unstable physical addresses and landlines. The incoming call feature of most cell phones was useful for participants and research staff alike, and texting proved to have additional benefits. However, reliance on participants' cell phones also proved problematic. Even homeless participants were found to have access to the Internet through public libraries and could respond to study staff e-mails. Some study sites opened generic social media accounts, through which study staff sent private messages to participants. However, the institutional review board (IRB) approval process for tracking participants using social media at some sites was prohibitively lengthy. Internet searches through Google, national paid databases, obituaries, and judiciary Web sites were also helpful tools. CONCLUSIONS: Research staff perceive that cell phones, Internet searches, and social networking sites were effective tools to achieve high follow-up rates in drug abuse research. Studies should incorporate cell phone, texting, and social network Web site information on locator forms; obtain IRB approval for contacting participants using social networking Web sites; and include Web searches, texting, and the use of social media in staff training as standard operating procedures.

Socioeconomic disparities in telephone-based treatment of tobacco dependence.

OBJECTIVES: We examined socioeconomic disparities in tobacco dependence treatment outcomes from a free, proactive telephone counseling quitline. METHODS: We delivered cognitive-behavioral treatment and nicotine patches to 6626 smokers and examined socioeconomic differences in demographic, clinical, environmental, and treatment use factors. We used logistic regressions and generalized estimating equations (GEE) to model abstinence and account for socioeconomic differences in the models. RESULTS: The odds of achieving long-term abstinence differed by socioeconomic status (SES). In the GEE model, the odds of abstinence for the highest SES participants were 1.75 times those of the lowest SES participants. Logistic regression models revealed no treatment outcome disparity at the end of treatment, but significant disparities 3 and 6 months after treatment. CONCLUSIONS: Although quitlines often increase access to treatment for some lower SES smokers, significant socioeconomic disparities in treatment outcomes raise questions about whether current approaches are contributing to tobacco-related socioeconomic health disparities. Strategies to improve treatment outcomes for lower SES smokers might include novel methods to address multiple factors associated with socioeconomic disparities.

A randomized study of contingency management and spirometric lung age for motivating smoking cessation among injection drug users.

BACKGROUND: Even after quitting illicit drugs, tobacco abuse remains a major cause of morbidity and mortality in former injection drug users. An important unmet need in this population is to have effective interventions that can be used in the context of community based care. Contingency management, where a patient receives a monetary incentive for healthy behavior choices, and incorporation of individual counseling regarding spirometric "lung age" (the age of an average healthy individual with similar spirometry) have been shown to improve cessation rates in some populations. The efficacy of these interventions on improving smoking cessation rates has not been studied among current and former injection drug users. METHODS: In a randomized, factorial design study, we recruited 100 active smokers from an ongoing cohort study of current and former injection drug users to assess the impact of contingency management and spirometric lung age on smoking cessation. The primary outcome was 6-month biologically-confirmed smoking cessation comparing contingency management, spirometric lung age or both to usual care. Secondary outcomes included differences in self-reported and biologically-confirmed cessation at interim visits, number of visits attended and quit attempts, smoking rates at interim visits, and changes in Fagerstrom score and self-efficacy. RESULTS: Six-month biologically-confirmed smoking cessations rates were 4% usual care, 0% lung age, 14% contingency management and 0% for combined lung age and contingency management (p = 0.13). There were no differences in secondary endpoints comparing the four interventions or when pooling the lung age groups. Comparing contingency management to non-contingency management, 6-month cessation rates were not different (7% vs. 2%; p = 0.36), but total number of visits with exhaled carbon monoxide-confirmed abstinence were higher for contingency management than non-contingency management participants (0.38 vs. 0.06; p = 0.03), and more contingency management participants showed reduction in their Fagerstrom score from baseline to follow-up (39% vs. 18%; p = 0.03). CONCLUSIONS: While lung age appeared ineffective, contingency management was associated with more short-term abstinence and lowered nicotine addiction. Contingency management may be a useful tool in development of effective tobacco cessation strategies among current and former injection drug users. TRIAL REGISTRATION: Clinicaltrials.gov NCT01334736 (April 12, 2011).

Promoting careers in academic research to psychiatry residents.

OBJECTIVE: With the shift of interest in psychiatry towards patient-oriented research with clinically relevant outcomes, there is a critical need for well-trained psychiatrist-scientists. The authors report on two developmentally tailored, longitudinal research training curricula designed to use peer mentoring to bridge the gap between physicians and scientists and to promote careers in academic research. METHODS: The authors instituted two independent research training curricula, one for first-year and one for second-to-fourth-year psychiatry residents, spanning two campuses of one institutional residency training program. Each curriculum's participants included psychiatry residents and peer scientific investigators, and both were attended by senior scientists and departmental leaders. The authors developed and administered an anonymous survey at the end of the first cycle of the first-year resident curriculum to assess participant attitudes. RESULTS: The first-year and second-to-fourth-year resident curricula have been implemented for 3 and 2 years, respectively. The authors observed overall participant satisfaction with the first-year curricula, independent of trainee status. Furthermore, first-year psychiatry residents reported increased interest in academic research careers after exposure to the curricula. CONCLUSIONS: Results suggest that it is possible to encourage academic research careers using peer mentoring, an innovative approach that requires minimal funding, causes little disruption to the residents' schedule and engages the gamut of individuals involved in psychiatry care and research: psychiatrists-in-training and young non-clinician scientists-in-training.

In-person and telephone treatment of tobacco dependence: a comparison of treatment outcomes and participant characteristics.

OBJECTIVES: We compared participant characteristics and abstinence outcomes of smokers who chose in-person or telephone tobacco dependence treatment. METHODS: We provided the same treatment content to 7267 smokers in Arkansas between 2005 and 2008 who self-selected treatment modality; examined demographic, clinical, environmental, and treatment utilization differences between modalities; and modeled outcomes and participants' choice of modality with logistic regression. RESULTS: At end of treatment, in-person participants were more likely to be abstinent than telephone participants, and smokers of higher socioeconomic status (SES) were more likely to be abstinent with telephone treatment than lower-SES smokers. Long term, modality had no effect on treatment outcomes. Higher-SES smokers and smokers exposed to more treatment content were more likely to achieve long-term abstinence, regardless of modality. Men and more recalcitrant smokers were more likely to choose in-person treatment; lower-SES, ethnic minority, and more dependent smokers were more likely to choose telephone treatment. CONCLUSIONS: Treatment modality attracts different groups of smokers, but has no effect on long-term abstinence. Multiple treatment modalities are needed to provide treatment to a heterogeneous population of smokers. More research is needed to understand the influences on treatment choice.

Effects of varenicline on abstinence and smoking reward following a programmed lapse.

INTRODUCTION: Varenicline (Chantix®) is an efficacious first-line medication for smoking cessation. Studies suggest that one mechanism by which varenicline facilitates sustained smoking abstinence is by reducing the likelihood of relapse to smoking when a lapse, or slip, occurs during a quit attempt. The present study extends this line of research by conducting a prospective laboratory study to examine the relapse prevention effects of varenicline following a programmed lapse. METHODS: Daily smokers (N = 47) completed a 5-week outpatient study in which they were randomized to receive varenicline or placebo. The first week was a medication induction period that was immediately followed by a 4-week quit attempt. A programmed lapse (2 cigarettes smoked in the laboratory) occurred on the second day of the quit attempt. RESULTS: Participants receiving varenicline were slower to relapse and had greater total abstinence rates following lapse exposure. Participants in the varenicline group rated lapse cigarettes lower on measures of reward and intoxication and showed increased behavioral economic demand elasticity for cigarettes (reduced cigarette purchasing at higher prices) compared with those receiving placebo. CONCLUSIONS: These results demonstrate a relapse prevention effect of varenicline following smoking lapse exposure and suggest that an attenuation of reward from smoking and the blunting of subjective effects of smoking may underlie and/or contribute to this effect.

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.

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.

Socioeconomic disparities in community-based treatment of tobacco dependence.

OBJECTIVES: We examined socioeconomic disparities in a community-based tobacco dependence treatment program. METHODS: We provided cognitive-behavioral treatment and nicotine patches to 2739 smokers. We examined treatment use, clinical and environmental, and treatment outcome differences by socioeconomic status (SES). We used logistic regressions to model end-of-treatment and 3- and 6-month treatment outcomes. RESULTS: The probability of abstinence 3 months after treatment was 55% greater for the highest-SES than for the lowest-SES (adjusted odds ratio [AOR] = 1.55; 95% confidence interval [CI] = 1.03, 2.33) smokers and increased to 2.5 times greater for the highest-SES than for the lowest-SES smokers 6 months after treatment (AOR = 2.47; 95% CI = 1.62, 3.77). Lower-SES participants received less treatment content and had fewer resources and environmental supports to manage a greater number of clinical and environmental challenges to abstinence. CONCLUSIONS: Targets for enhancing therapeutic approaches for lower socioeconomic groups should include efforts to ensure that lower-SES groups receive more treatment content, strategies to address specific clinical and environmental challenges associated with treatment outcomes for lower-SES smokers (i.e., higher dependence and stress levels and exposure to other smokers), and strategies to provide longer-term support.

Delay discounting, locus of control, and cognitive impulsiveness independently predict tobacco dependence treatment outcomes in a highly dependent, lower socioeconomic group of smokers.

Tobacco use disproportionately affects lower socioeconomic status (SES) groups. Current explanations as to why lower SES groups respond less robustly to tobacco control efforts and tobacco dependence treatment do not fully account for this disparity. The identification of factors that predict relapse in this population might help to clarify these differences. Good candidates for novel prognostic factors include the constellation of behaviors associated with executive function including self-control/impulsiveness, the propensity to delay reward, and consideration and planning of future events. This study examined the ability of several measures of executive function and other key clinical, psychological, and cognitive factors to predict abstinence for highly dependent lower SES participants enrolled in intensive cognitive-behavioral treatment for tobacco dependence. Consistent with predictions, increased discounting and impulsiveness, an external locus of control as well as greater levels of nicotine dependence, stress, and smoking for negative affect reduction predicted relapse. These findings suggest that these novel factors are clinically relevant in predicting treatment outcomes and suggest new targets for therapeutic assessment and treatment approaches.

Adolescent Substance Abuse and Mental Health: Problem Co-Occurrence and Access to Services.

The purpose of this study is to identify factors associated with adolescent alcohol or drug (AOD) abuse/dependence, mental health and co-occurring problems; as well as factors associated with access to treatment. This is a secondary analysis of data from the National Survey on Drug Use and Health (NSDUH) 2000. The 12-month prevalence rate of adolescents with only mental health problems was 10.8%, 5.1% had only AOD abuse/dependence only, and 2.7% had co-occurring problems. Approximately 15% of youth reported receiving behavioral health treatment in the past 12 months. Several factors associated with having behavioral health problems and receiving treatment are presented.