Papers by Judith Prochaska
ADMINISTRATIVE BUDGET NOTE: The budget shown is the requested budget and has not been adjusted to... more ADMINISTRATIVE BUDGET NOTE: The budget shown is the requested budget and has not been adjusted to reflect any recommendations made by reviewers. If an award is planned, the costs will be calculated by Institute grants management staff based on the recommendations outlined below in the COMMITTEE BUDGET RECOMMENDATIONS section.
JAMA, Jul 11, 2023
ImportanceCytisinicline (cytisine) is a plant-based alkaloid that, like varenicline, binds select... more ImportanceCytisinicline (cytisine) is a plant-based alkaloid that, like varenicline, binds selectively to α4β2 nicotinic acetylcholine receptors, which mediate nicotine dependence. Although not licensed in the US, cytisinicline is used in some European countries to aid smoking cessation, but its traditional dosing regimen and treatment duration may not be optimal.ObjectiveTo evaluate the efficacy and tolerability of cytisinicline for smoking cessation when administered in a novel pharmacokinetically based dosing regimen for 6 or 12 weeks vs placebo.Design, Setting, and ParticipantsA 3-group, double-blind, placebo-controlled, randomized trial (ORCA-2) compared 2 durations of cytisinicline treatment (6 or 12 weeks) vs placebo, with follow-up to 24 weeks, among 810 adults who smoked cigarettes daily and wanted to quit. It was conducted at 17 US sites from October 2020 to December 2021.InterventionsParticipants were randomized (1:1:1) to cytisinicline, 3 mg, 3 times daily for 12 weeks (n = 270); cytisinicline, 3 mg, 3 times daily for 6 weeks then placebo 3 times daily for 6 weeks (n = 269); or placebo 3 times daily for 12 weeks (n = 271). All participants received behavioral support.Main Outcomes and MeasuresBiochemically verified continuous smoking abstinence for the last 4 weeks of cytisinicline treatment vs placebo (primary) and from end of treatment to 24 weeks (secondary).ResultsOf 810 randomized participants (mean age, 52.5 years; 54.6% female; mean of 19.4 cigarettes smoked daily), 618 (76.3%) completed the trial. For the 6-week course of cytisinicline vs placebo, continuous abstinence rates were 25.3% vs 4.4% during weeks 3 to 6 (odds ratio [OR], 8.0 [95% CI, 3.9-16.3]; P < .001) and 8.9% vs 2.6% during weeks 3 to 24 (OR, 3.7 [95% CI, 1.5-10.2]; P = .002). For the 12-week course of cytisinicline vs placebo, continuous abstinence rates were 32.6% vs 7.0% for weeks 9 to 12 (OR, 6.3 [95% CI, 3.7-11.6]; P < .001) and 21.1% vs 4.8% during weeks 9 to 24 (OR, 5.3 [95% CI, 2.8-11.1]; P < .001). Nausea, abnormal dreams, and insomnia occurred in less than 10% of each group. Sixteen participants (2.9%) discontinued cytisinicline due to an adverse event. No drug-related serious adverse events occurred.Conclusions and RelevanceBoth 6- and 12-week cytisinicline schedules, with behavioral support, demonstrated smoking cessation efficacy and excellent tolerability, offering new nicotine dependence treatment options.Trial RegistrationClinicalTrials.gov Identifier: NCT04576949
Journal of the American College of Cardiology, Aug 1, 2016
An addictive, legal product, tobacco is challenging to quit. Although cessation medications and b... more An addictive, legal product, tobacco is challenging to quit. Although cessation medications and behavioral therapies improve success rates, recent research in behavioral economics suggests an interesting, simple approach: pay smokers to quit. This idea has been tested in a few studies. Volpp et al. (1) found that a cash reward of $750 U.S. dollars (USD) increased abstinence 3-fold, from 5% to 15%. A meta-analysis of 9 trials of financial incentives showed increased abstinence during the payment period, but effects were lost once the rewards ended (2). In this issue of the Journal, Etter and Schmid (3) focused on low-income smokers in Geneva, Switzerland, who were motivated to quit. The study was conducted outside of the workplace, and 42% of participants were students and another 19% were unemployed, with a median income of just USD $20,000. As tobacco use has become increasingly concentrated among those of lower education and income, the unemployed, and young adults, treatments that work outside of the clinic or worksite are needed (4). All participants were provided a cessation booklet, and encouraged to obtain information about quitting from the study's website and engage a friend or family member to support their quit attempt. The intervention group received an escalating financial incentive of up to USD $1,650 in supermarket vouchers for biochemically confirmed abstinence at 6 time points over the 6month follow-up. The intervention group was significantly more likely than the control group to read the cessation booklet (64% vs. 55%), access online cessation help (20% vs. 14%), and register a supporter (8% vs. 3%). Furthermore, the intervention group was more likely to provide
Journal of the American College of Cardiology, Feb 1, 2013
Background Smoking is an important cardiovascular risk factor and smoking cessation should be a p... more Background Smoking is an important cardiovascular risk factor and smoking cessation should be a primary target in secondary prevention after a myocardial infarction (MI). Purpose The purpose of this study was to examine whether personality, coping and depression were related to smoking cessation after an MI. Method MI patients ≤70 years (n=323, 73 % men, 58.7± 8.3 years), participating in the Secondary Prevention and Compliance following Acute Myocardial Infarction study in Malmö, Sweden, between 2002 and 2005, were interviewed by a psychologist to assess coping strategies and completed Beck Depression and NEO Personality Inventories, in close proximity to the acute event. Correlation between smoking status (current, former and never), personality factors, coping and depression was assessed at baseline and 24 months after the MI using logistic regression and in a multivariate analysis, adjusting for age and sex. Results Of the participating patients, 46 % were current smokers. Two years after the event, 44 % of these were still smoking. At baseline, current smokers scored higher on the depression and neuroticism scales and had lower agreeableness scores. Patients who continued to smoke after 2 years had higher scores on being confrontational (i.e. confrontative coping style) compared to those who had managed to quit. Patients who continued to smoke had significantly lower agreeableness and were more often living alone. Conclusion Personality, coping strategies and psychosocial circumstances are associated with smoking cessation rates in patients with MI. Considering personality factors and coping strategies to better individualise smoking cessation programs in MI patients might be of importance.
The Cochrane library, Jun 6, 2013
Background-The reinforcing properties of nicotine may be mediated through release of various neur... more Background-The reinforcing properties of nicotine may be mediated through release of various neurotransmitters both centrally and systemically. People who smoke report positive effects such as pleasure, arousal, and relaxation as well as relief of negative affect, tension, and anxiety. Opioid (narcotic) antagonists are of particular interest to investigators as potential agents to attenuate the rewarding effects of cigarette smoking. Objectives-To evaluate the efficacy of opioid antagonists in promoting long-term smoking cessation. The drugs include naloxone and the longer-acting opioid antagonist naltrexone. Search methods-We searched the Cochrane Tobacco Addiction Group Specialised Register for trials of naloxone, naltrexone and other opioid antagonists and conducted an additional search of MEDLINE using 'Narcotic antagonists' and smoking terms in April 2013. We also contacted investigators, when possible, for information on unpublished studies. Selection criteria-We considered randomised controlled trials comparing opioid antagonists to placebo or an alternative therapeutic control for smoking cessation. We included in the metaanalysis only those trials which reported data on abstinence for a minimum of six months. We also
PLOS ONE, Sep 30, 2022
This cross-sectional study assessed how traditional eating relates to cultural and community fact... more This cross-sectional study assessed how traditional eating relates to cultural and community factors. Alaska Native adults from the Norton Sound region were recruited and surveyed between 2015-2018 for a randomized clinical trial of multiple risk behavior change interventions for cardiovascular disease prevention. Participants (n = 291) were 49% female with a mean age of 47 years (SD = 14). A 34-item food frequency questionnaire assessed consumption of foods traditional and nontraditional to the regional Alaska Native diet. A novel measure, termed the "traditional foods index", was computed as weekly servings of culturally traditional food consumption divided by total foods reported. Overall, the sample's traditional foods index averaged 21%±16%, with higher values reported by participants assessed in summer (23%±17%) than winter (19%±15%, p<0.05); by women (22%±16%) than men (19%±16%, p < .05); and by residents of smaller communities (22%±17%) than the comparatively larger community of Nome (17%±14%, p<0.05). The traditional foods index was correlated with age (r = .26, p < .01), as well as the cultural variables of community connectedness (r = .19, p < .01), community standing (r = .15, p < .01), and traditional language comprehension (r = .19, p < .01). In a multivariate regression model, age, community connectedness, and community standing remained significantly associated with traditional diet. These findings may inform the design and evaluation of community-based, culturally-relevant dietary initiatives for heart health.
JMIR Research Protocols, Nov 22, 2019
Background: Despite the high prevalence of tobacco use among Alaska Native (AN) people, tobacco c... more Background: Despite the high prevalence of tobacco use among Alaska Native (AN) people, tobacco cessation interventions developed specifically for this group are lacking. Social media hold promise as a scalable intervention strategy to promote smoking treatment utilization and cessation, given the barriers to treatment delivery (ie, geographic remoteness, limited funding, climate, and travel costs) in the state of Alaska (AK). Building on a longstanding tobacco control research partnership with the AK Tribal Health System, in this study, we are developing and pilot-testing a culturally relevant, Facebook (FB)-delivered intervention that incorporates a digital storytelling approach adapted from the effective Centers for Disease Control Tips from Former Smokers campaign. Objective: This study aims to promote evidence-based smoking treatment (eg, state quitline and Tribal cessation programs) uptake and cessation among AN people. Methods: This study fulfills the objectives for stage 1 of the National Institute on Drug Abuse behavioral integrative treatment development program. In stage 1a, we will use a mixed method approach to develop the FB intervention. Cultural variance and surface/deep structure frameworks will address the influence of culture in designing health messages. These developmental activities will include qualitative and quantitative assessments, followed by beta testing of proposed intervention content. In stage 1b, we will conduct a randomized pilot trial enrolling 60 AN adults who smoke. We will evaluate the feasibility, uptake, consumer response, and potential efficacy of the FB intervention compared with a control condition (quitline/treatment referral only). Primary outcome measures include feasibility and biochemically verified smoking abstinence at 1-, 3-, and 6-month follow-ups. Secondary outcomes will include self-reported smoking cessation treatment utilization and abstinence from tobacco/nicotine products. We will also explore interdependence (relationship orientation and collaborative efforts in lifestyle change) as a culturally relevant mediator of intervention efficacy. Results: The study enrolled 40 participants for phase 1, with data saturation being achieved at 30 AN people who smoke and 10 stakeholders. For phase 2, we enrolled 40 participants. Qualitative assessment of proposed intervention content was completed
Journal of The National Comprehensive Cancer Network, Mar 31, 2023
Contemporary Clinical Trials, Apr 1, 2023
The Psychiatric times, Mar 20, 2015
Here: assessment approaches, treatment options, and potential risks inherent in treating tobacco ... more Here: assessment approaches, treatment options, and potential risks inherent in treating tobacco dependence in individuals with major mental illnesses and substance use disorders.
Purpose of review Smoking remains the leading cause of preventable morbidity and mortality. Our r... more Purpose of review Smoking remains the leading cause of preventable morbidity and mortality. Our review highlights research from 2013 to 2015 on the treatment of cigarette smoking, with a focus on heart patients and cardiovascular outcomes. Recent findings Seeking to maximize the reach and effectiveness of existing cessation medications, current tobacco control research has demonstrated the safety and efficacy of combination treatment, extended use, reduce-to-quit strategies, and personalized approaches to treatment matching. Further, cytisine has gained interest as a lower-cost strategy for addressing the global tobacco epidemic. On the harm reduction front, snus and electronic nicotine delivery systems are being widely distributed and promoted with major gaps in knowledge of the safety of long-term and dual use. Quitlines, comparable in outcome to in-person treatment, make cessation counseling available on a national scale, though use rates remain relatively low. Employee reward programs are gaining attention given the high costs of tobacco use to employers; sustaining quit rates postpayment, however, has proven challenging. Summary Evidence-based cessation treatments exist. Broader dissemination, adoption, and implementation are key to addressing the tobacco epidemic. The cardiology team has a professional obligation to advance tobacco control efforts and can play an important role in achieving a smoke-free future.
Social Science Research Network, 2023
Journal of the National Comprehensive Cancer Network, 2022
Nicotine & Tobacco Research, 2020
Background Face-to-face tobacco cessation has had limited reach and efficacy in Alaska Native (AN... more Background Face-to-face tobacco cessation has had limited reach and efficacy in Alaska Native (AN) communities. We describe our two-phased approach to develop content for Connecting Alaska Native People to Quit Smoking, a Facebook group intervention to reduce barriers to evidence-based smoking cessation treatment for AN people in Alaska. Methods Phase 1 included semi-structured telephone interviews with 30 AN people who smoke and ten stakeholders. They provided feedback on existing content from the Centers for Disease Control and Prevention Tips campaign and AN digital stories. Phase 2 included an online survey with a new group of 40 AN smokers who provided feedback on existing content via a measure of perceived effectiveness and cultural relevance. Results Phase I results revealed participants evaluated content based upon story strength, relevance to AN culture, emotional appeal, relatability to AN people, and favorite video. No single posting was rated highly across all themes. Al...
Drug and Alcohol Dependence, 2021
BACKGROUND This study examined young people's e-cigarette risk perceptions, policy attitudes,... more BACKGROUND This study examined young people's e-cigarette risk perceptions, policy attitudes, and past-month nicotine vaping in 30 US cities in relation to city e-cigarette retail policy. METHODS Participants ages 13-20 were recruited online September-November 2020 (N = 900, approximately 30 per city). Cities (median population = 688,531) were in 23 states. Ever e-cigarette users were oversampled. A multilevel generalized estimating equations (GEE) model compared past-month nicotine vaping as a function of local e-cigarette retail policy. Among ever-users, multilevel bivariate GEE models examined associations of participant characteristics with past-month vaping (yes/no) and, among past-month nicotine vapers, purchase of vaping products at a retail location (yes/no). RESULTS The sample (age M = 17.7 [SD = 1.8]) was 60.2% female and 29.3% Black. Minimal city-level variation was observed in e-cigarette risk perceptions or policy attitudes (ICCs < 0.001). Nearly half the sample (44.6%) reported ever e-cigarette use; 11.8% reported past-month nicotine vaping. Past-month nicotine vaping was associated with older age, being non-Hispanic white, living with someone who vapes, having friends who vape, greater exposure to retail e-cigarette ads, lower e-cigarette risk perceptions, and lower perceived efficacy of flavored tobacco policy. Among ever-users, past-month nicotine vaping was not significantly associated with city e-cigarette flavor policy (p = .784). Most participants reporting past-month nicotine vaping purchased products in-store (58.5%). CONCLUSIONS Among young people surveyed in US cities, e-cigarette risk perceptions and policy attitudes showed minimal between-city variation. Past-month vaping among ever-users did not differ significantly by local flavor policies. A majority of past-month users, regardless of city policies, reported underage access to flavored products in retail locations.
Drug and Alcohol Dependence, 2021
Background The COVID-19 pandemic disrupted access to treatment for substance use disorders (SUDs)... more Background The COVID-19 pandemic disrupted access to treatment for substance use disorders (SUDs), while alcohol and cannabis retail sales increased. During the pandemic, we tested a tailored digital health solution, Woebot-SUDs (W-SUDs), for reducing substance misuse. Methods In a randomized controlled trial, we compared W-SUDs for 8 weeks to a waitlist control. U.S. adults (N = 180) who screened positive for substance misuse (CAGE-AID>1) were enrolled June–August 2020. The primary outcome was the change in past-month substance use occasions from baseline to end-of-treatment (EOT). Study retention was 84%. General linear models tested group differences in baseline-to-EOT change scores, adjusting for baseline differences and attrition. Results At baseline, the sample (age M = 40, SD = 12, 65% female, 68% non-Hispanic white) averaged 30.2 (SD = 18.6) substance occasions in the past month. Most (77%) reported alcohol problems, 28% cannabis, and 45% multiple substances; 46% reported moderate-to-severe depressive symptoms. Treatment participants averaged 920 in-app text messages (SD = 892, Median = 701); 96% of completed lessons were rated positively; and 88% would recommend W-SUDs. Relative to waitlist, W-SUDs participants significantly reduced past-month substance use occasions (M = −9.1, SE = 2.0 vs. M = −3.3, SE = 1.8; p = .039). Secondary substance use and mood outcomes did not change significantly by group; however, reductions in substance use occasions correlated significantly with increased confidence and fewer substance use problems, cravings, depression and anxiety symptoms, and pandemic-related mental health effects (p-value<.05). Conclusions W-SUDs was associated with significant reductions in substance use occasions. Reduction in substance use occasions was associated with better outcomes, including improved mental health. W-SUDs satisfaction was high.
The Lancet Child & Adolescent Health, 2021
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Papers by Judith Prochaska