The overarching goal of this application for a Phase 3 Center of Biomedical Research Excellence (COBRE) award is to firmly establish the Vermont Center on Behavior and Health (VCBH) at the University of Vermont (UVM) as a sustainable center of research excellence. 

The VCBH made considerable progress during Phases 1 and 2 towards becoming a vibrant and sustainable center. VCBH established a strong record of external grant support and peer-reviewed publications with $165.1 million in total cumulative funding, including $18.3 million from awards to COBRE Project Leaders (PLs), and 917 articles in peer-reviewed journals, including 515 listing PLs as 1st or co-authors. PLs succeeded in obtaining NIH, foundation, and industry awards as PIs, Project PIs, and Co-Is. Other Phase 1 and 2 notable accomplishments included establishing an NIH-supported UVM Tobacco Center of Regulatory Science with an initial P50 award that was renewed as a U54, twice renewing an NIH T32 training award in clinical addictions research now in years 31-36, and establishing the new HRSA-supported UVM Center on Rural Addiction and a new NIH T32 training award in neurobiological addiction research. VCBH cores continue to support a vibrant monthly lecture series, annual national conferences, and guest editorship of an annual special issue of the peer-reviewed journal Preventive Medicine based on the conferences. VCBH collaborations with other COBREs continue to grow, with VCBH PI Dr. Higgins chairing two COBRE External Advisory Committees and serving as a member of a third. 

In Phase 3, we propose to sustain VCBH competitiveness in obtaining external grant support and fostering new research and dissemination initiatives. We will continue mentoring early career investigators, leveraging our three cores that have strong institutional support and broad reach, and coalescing VCBH collaborations around five areas of scientific strength, each with its own working group. An innovative Pilot Project Program will be leveraged to support early-career investigators and generate preliminary data for grant applications in current areas of strength and to foster new research directions. We are confident that with Phase 3 support, VCBH is well positioned to succeed as a sustainable, impactful, multidisciplinary center of research excellence.

Primary Investigator: Stephen Higgins, Ph.D.
Funding Source: National Institutes of Health (NIH)
Grant Type: Centers of Biomedical Research Excellence (COBRE)
Duration: 5 years
Award#: 5P30GM149331

Aim 1: Recruit and organize the multidisciplinary senior and early-career faculty and advisors necessary to lead and sustain the VCBH mission.

Aim 2: Provide promising early-career faculty with the research opportunities, mentoring, and career development support necessary to establish themselves as successful, independent investigators.

Aim 3: Establish an Administrative Core that effectively leads and coordinates a multidisciplinary research center of excellence, trains the next generation of scholars, and obtains the external funding necessary to sustain the VCBH beyond COBRE support.

Aim 4: Establish a research core that supports the efforts of investigators in the VCBH and beyond to study behavior and health relationships pertinent to the VCBH mission. The Behavioral Economics and Intervention Sciences Core (Core B) consists of the following three modules of expertise:

(a) A Decision-Making component that supports research strategies and instruments to examine individual differences in biases and deficiencies in decision-making (e.g., temporal discounting, other executive functions) using conventional paper-and-pencil and laptop assessment platforms, as well as those that leverage functional magnetic resonance imaging (fMRI) testing.

(b) An Intervention Sciences component that (i) assists with development and evaluation of behavior change interventions, and (ii) supports the integration of emerging technologies with those interventions;

(c) An Economic Modeling component that assists with developing and implementing cost-effectiveness analyses for the intervention studies.

Aim 5: Establish a Collaboration, Dissemination, and Education Core (Core C) that facilitates local, state, national, and international impact and educates the next generation of scholars in Behavior and Health by:

(a) Nurturing and coordinating bi-directional collaborative relationships with (i) Vermont leaders in health care policy and delivery, (ii) a network of universities and research institutes located in other IDeA states (Brown University, University of Kentucky, Dartmouth, University of Nebraska, Laureate Institute for Brain Research), non-IDEA states (Johns Hopkins University, State University of New York at Buffalo, Wayne State University), and internationally (University of Glasgow, Glasgow, Scotland; Oviedo University, Oviedo, Spain; Makerere University, Kampala, Uganda) where there is strong interest and expertise in the area of behavior and health;

(b) Disseminating new knowledge on behavior and health through the annual VCBH national conference and annual Special Issues of the peer-reviewed journal Preventive Medicine;

(c) Educating the next generation of scholars in the area of behavior and health through the VCBH monthly lecture series, seminars, and workshops offered at UVM and also streamed live to collaborators and interested others.

The UVM Center on Rural Addiction (CORA) Rural Center of Excellence on Substance Use Disorder (SUD) Treatment is one of three Rural Centers of Excellence (RCOEs), funded by the Health Resources and Services Administration (HRSA). The RCOEs work to disseminate evidence-based training and support to reduce the burden of SUDs, including opioid use disorder (OUD), in rural communities across the United States.  

The UVM CORA team provides a broad array of resources to rural healthcare providers engaged in treating patients with SUDs as well as other co-occurring behavioral health disorders. Our efforts include technical assistance for rural practitioners and community partners, clinician office hours, Community Rounds webinar sessions, quarterly newsletters, evidence-based resource guides, research spotlights, user guides, presentations and trainings to community partners and rural organizations, and collection of real-time data to guide our disseminate and outreach efforts. Since UVM CORA’s inception in 2019, we have supported over 35,000 rural healthcare providers in all 50 states and provided >930 CME credits across our entire rural addiction training portfolio.

For more information, please visit our website: Helping patients by helping providers - Center on Rural Addiction UVM

Primary Investigator: Stacey C. Sigmon, Ph.D.
Funding Source: Health Resources and Services Administration (HRSA)
Grant Type: Rural Communities Opioid Response Program (RCORP) - Rural Center of Excellence (RCOE)
Duration: Established in 2019
Award#: UD9RH33633

1. Identify the real-time needs and best practices needed to effectively address the current OUD treatment needs in rural communities.
2. Disseminate education and resources on evidence-based approaches for addressing SUD epidemics and facilitating rural healthcare provider workforce development.
3. Deliver systematic technical assistance in the selection, implementation and ongoing use of best practices to assess and treat rural patients’ SUDs and related needs among rural residents. 
4. Support expansion of OUD treatment capacity in rural communities using science-based knowledge and methods. 

Our overarching aim is to support capacity building for evidence-based addiction treatment and prevention. Building on new and existing partnerships, our UVM Center on Rural Addiction teams collaborate closely with partners in states across the country to support expansion of evidence-supported OUD treatment capacity in rural communities.

VCBH is the home of the UVM Tobacco Center of Regulatory Science (TCORS), one of nine such centers in the U.S. that are supported through a cooperative agreement of the National Institutes of Health (NIH) and Food and Drug Administration (FDA). The Family Smoking Prevention and Tobacco Control Act has given the federal government (i.e., FDA) the authority to bring science-based regulation to the manufacturing, marketing, and distribution of tobacco products. UVM and the other TCORS centers will provide scientific expertise relevant to the FDA’s regulatory mission. 

VCBH addresses one of the crosscutting and two of the specific research priorities of the FDA Center for Tobacco Products in carrying out its charge of regulating tobacco products. We approach these priorities using the concepts, principles, and methods of behavioral economics and behavioral pharmacology. We work closely with collaborators and consultants from Brown University, Johns Hopkins University, University of Minnesota, and University of Pittsburgh. 

We will continue our crosscutting integrative theme of vulnerable populations focusing on two FDA Center for Tobacco Products scientific domains: addiction and behavior. More specifically, we plan to expand our center's research on nicotine standards for cigarettes and addiction risk in populations already at an increased risk for:

• cigarette smoking,
• addiction, and
• smoking-related adverse health outcomes, including socioeconomically disadvantaged populations, individuals with other substance use disorders, and individuals with mental illness.

We will extend our research applying the principles and methods of behavioral economics, behavioral pharmacology, and neuroimaging to examine the effects of reducing the nicotine content of cigarettes on cigarette smoking in vulnerable populations with and without substitute non-combusted nicotine products readily available. We will also examine whether flavors enhance appeal of the non-combusted alternative. 

The purpose of this application is to continue the University of Vermont’s highly successful 30-year T32 training program in the human behavioral pharmacology of drug use disorders. 

During the past 15 years, we trained 16 predoctoral and 22 postdoctoral fellows. Among those 38 fellows, all but two remain involved in research-related careers. Twenty-five have completed the training phase of their careers. Among those 25, 14 (58%) have primary university faculty/research-institute positions, six (24%) have been principal investigators (PI) on one or more NIH research awards, seven (28%) are employed by government agencies, two (8%) work in industry, and collectively they have more than 500 peer-reviewed publications on addiction. In addition to being a productive training program, the training our fellows receive in human behavioral pharmacology fills a unique niche in addiction research. Our fellows learn to identify basic behavioral and pharmacological processes underpinning addiction and to translate that knowledge into effective clinical interventions and policy. We propose to continue our emphasis on human behavioral pharmacology in the next funding period, continuing our expansion into tobacco regulatory science and the impact of addictive behavior on health outcomes. 

Since the last T32 renewal, we renewed our U54 Tobacco Centers of Regulatory Science (TCORS) and P20 Center of Biomedical Research Excellence (COBRE) awards in behavior and health, and obtained a new UD9 Center Award in Rural Addiction. These Centers add value to our training program via access to additional seminars, guest lectures, interactions with additional fellows and guests, and new research and career opportunities. Indeed, three of our T32 fellows have taken research scientist positions with FDA’s division on tobacco regulation. We propose to continue supporting four predoctoral and four postdoctoral training slots with this T32 award. The eight members of the proposed training faculty consist of seven PhDs and one MD. These faculty members are PIs on three NIH/HRSA center grants, five R01s, two R33/34s, two R21s, and one private- foundation award creating a rich range of training opportunities in addiction research. 

All faculty and fellows are located at a single, on-campus site composed of 8000 sq. ft of newly renovated space. Fellows are selected based on scholastic excellence and commitment to a career in addiction research. Predoctoral fellows are enrolled in the Department of Psychological Science PhD programs in experimental or clinical psychology where they complete required coursework including those developed for this training program, and complete master’s and doctoral theses. Postdoctoral fellows primarily focus on conducting and supervising independent research, with additional opportunities to further their education via coursework. Each fellow has a primary mentor from the training faculty. Fellows attend weekly seminars in addiction research and ethics. Additionally, they present their research at two or more national scientific meetings annually. The training period is generally 4-5 years for predoctoral and 2-3 years for postdoctoral fellows. 

The overarching goal of the proposed training program is to continue developing productive, independent, state-of-the-art addiction researchers.

Primary Investigators: Stephen Higgins, Ph.D., and Sarah Heil, Ph.D.
Funding Source: National Institute on Drug Abuse (NIDA)
Grant Type: T32 Training Grant
Duration: 5 years
Award#: 5T32DA007242
Notice Date: May 2025

A fine-grained naturalistic cohort study to investigate dynamic use patterns and trajectories that lead to smoking cessation

As the tobacco product landscape continues to shift, there has been a dramatic increase in poly-tobacco use, particularly the dual use of combustible and electronic (e-)cigarettes. The health implications of dual use are unclear, as are the treatment and policy decisions as to how to best manage it. On one hand, dual use has the potential to decrease both individual and population harm, insofar that toxicant exposure is lowered and eventual cessation of combustible cigarettes becomes possible, as growing evidence suggests. However, harm reduction is maximized only when dual users transition completely away from combustible cigarette smoking, and when that transition is sustained. Indeed, the potential benefits of e-cigarettes are unrealized if dual users fail to quit smoking. Thus, dual use has the potential to reduce or perpetuate harm. The critical difference between these two outcomes is how these harm reducing/promoting tobacco products are used interchangeably; i.e., patterns and trajectories over time. Unfortunately, the natural course of dual use, particularly in comparison to exclusive smoking or vaping, is unclear. Cohort studies of dual use, often derived as secondary analyses from national surveillance projects with yearly assessments, suggest that, for some, dual use can be either transient or prolonged. Almost all of these studies lack detail on anything beyond use status (using vs. not), and particularly lack detail on daily patterns of use over time. A focused and more granular assessment of dual use patterns is needed to understand who these individuals really are, and how their smoking and vaping behaviors do and do not change over time. 

Within a nationally based cohort study of dual users (n=396), and exclusive users of both combustible (n=198) and e-cigarettes (n=198), natural use histories will be assessed through a combination of a) detailed daily diaries over 3 months, b) serial bursts of nightly diaries that coincide with c) episodic monthly surveys over a 1-year follow-up, and d) biological verification of combustible cigarette smoking. Study aims are to 1) describe, and 2) compare the consistency of use behaviors over time, within and across cohorts. As a third aim, using a within-subjects approach, we aim to assess the defining day-to-day patterns of dual use that best predict subsequent abstinence from combustible cigarette smoking. 

The proposed project is the largest and longest study of dual users (vs. exclusive users) ever conducted with a priori design considerations to more fully understand the complex interplay between these two products, one of which is the root cause of significant cancer incidence and mortality, and the other is a controversial harm reduction option with fast growing population appeal. Building upon a successful program of cancer prevention research using naturalistic research designs, remote methods, and team science, the proposed study expands our foundational knowledge regarding tobacco use behavior and cessation among and across different groups of tobacco product users. Ultimately, and regardless of outcome, our results will inform clinical and regulatory decision making of novel products that may enable or impede the proliferation and marketing of the fastest growing segment of the tobacco marketplace.

Primary Investigators: Elias Klemperer, Ph.D., and Matthew Carpenter, Ph.D.
Partner Organization: Medical University of South Carolina
Funding Source: National Institutes of Health (NIH)
Grant Type: R01
Duration: 5 years
Award#: 5R01DA061566
Notice Date: April 2025

Cigarette smoking remains the leading cause of preventable morbidity and mortality in the US. Use of multiple tobacco products is becoming increasingly prevalent, with dual use of e-cigarettes and cigarettes representing the most common combination. Though e-cigarettes are not without risk, completely switching from cigarettes to e-cigarettes likely reduces risk for tobacco-related harm. However, the vast majority of established dual users maintain long-term smoking and the majority, who use e-cigarettes non-daily, are at an even greater risk for prolonged smoking than exclusive cigarette smokers. The Food and Drug Administration Center for Tobacco Products (FDA CTP) has announced plans to implement a nicotine-limiting product standard, capping the nicotine in cigarettes at a minimally or non-addictive level. Randomized controlled trials (RCTs) demonstrate that exclusive smokers respond to very low nicotine content (VLNC) cigarettes with reductions in smoking, demand, and dependence. However, nicotine reduction RCTs to date have excluded regular e-cigarette users and therefore it remains unclear how a nicotine-limiting standard for cigarettes would affect smoking among dual users. Given the potential substitutability of e-cigarettes for cigarettes, reducing the nicotine in cigarettes could promote a transition to exclusive e-cigarette use among dual users unable to completely quit nicotine, but only if sufficiently appealing e-cigarettes remain available. E-cigarettes containing 5% nicotine-salt solution are currently most popular in the US but policy makers have proposed restricting e-cigarettes to ≤2% nicotine to curb youth e-cigarette use. Prior laboratory studies indicate that higher vs lower nicotine e-cigarettes serve as better substitutes for cigarettes among adult dual users. As such, a restriction on e-cigarette nicotine concentration could undermine the potential for e-cigarettes to substitute for cigarettes and diminish the benefits of a nicotine-limiting standard for cigarettes among dual users. We propose a 12-week double-blind 2 cigarette level (Normal Nicotine vs Very Low Nicotine) x 2 e-cigarette level (High Nicotine vs Low Nicotine) between-subjects factorial trial to investigate how a nicotine-limiting standard for cigarettes affects adult dual users and whether these effects are impacted by constraints on e-cigarette nicotine concentration. Outcome measures include cigarettes per day, cigarette dependence, and toxicant exposure. The research is highly relevant to FDA CTP domains of Addiction and Behavior because it will test whether reducing the nicotine content of cigarettes reduces smoking and dependence, and whether these effects are moderated by the availability of high vs low nicotine e-cigarettes. It also addresses the Health Effects domain by assessing toxicant exposure. It is innovative because it is, to our knowledge, the first RCT of a nicotine-limiting standard among the growing population of US adults who use multiple tobacco products. Finally, it is programmatic as it builds upon a decade of nicotine reduction research that we have conducted. Overall, this trial has the potential to provide FDA CTP with evidence on an understudied population important to its regulatory responsibilities.

Primary Investigator: Elias Klemperer, Ph.D.
Funding Source: National Institutes of Health (NIH)
Grant Type: R01
Duration: 5 years
Award#: 1R01DA059562
Notice Date: 

Nearly 90% of individuals with OUD report lifetime trauma exposure and 33% meet criteria for PTSD. Patients with co-occurring PTSD and OUD are at significantly greater risk for poor substance use and mental health outcomes vs. those with OUD alone. Although Prolonged Exposure (PE) therapy is a first-line treatment for PTSD, its efficacy is commonly undermined by poor attendance. We recently demonstrated the initial feasibility of a novel PE protocol for improving therapy attendance and PTSD symptoms among individuals maintained on MOUD. Participants were randomly assigned to: (a) Treatment as usual (TAU) (b) Prolonged Exposure therapy (PE) or (c) PE with attendance contingent financial incentives (PE+). Our results demonstrated the initial efficacy of PE+, as PE+ participants attended significantly more therapy sessions than PE participants and experienced significant improvements in PTSD symptoms. Our findings also suggest that, rather than undermining patients’ stability with illicit drug use, PE may be associated with less illicit substance use than SUD treatment alone. In the proposed research, we seek to: a) conduct a more definitive evaluation of this novel PE intervention, b) utilize a novel telemedicine platform to reach underserved patients, and c) further investigate this promising initial data suggesting that PE therapy may also be associated with improvements in illicit drug use. Primary Aim: To evaluate the efficacy of a novel telemedicine-delivered PE protocol for improving therapy attendance and PTSD symptoms. We will conduct a parallel three-group RCT among 135 adults with PTSD who are maintained on MOUD (45 TAU, 45 PE, 45 PE+). All study visits will be conducted via telemedicine and attendance-contingent financial incentives will be delivered digitally. We hypothesize that participants assigned to PE+ will demonstrate greater PE session attendance and decreases in PTSD severity relative to those assigned to PE or TAU. Secondary Aims: (1) We will utilize rigorous and fine-grained assessment strategies to evaluate whether individuals receiving PE may actually experience reductions in their illicit opioid and other drug use. (2) We will conduct the first characterization of telemedicine-delivered PE acceptability and explore their association with PE treatment retention and PTSD symptom reduction. This study represents the first effort to examine the efficacy of PE delivered via telemedicine to individuals with OUD, and our investigative team is uniquely poised to disseminate our findings to improve clinical practice in real-world settings throughout the country.

Primary Investigator: Kelly Peck, Ph.D.
Funding Source: National Institutes of Health (NIH)
Grant Type: R01
Duration: 5 years
Award#: 1R01DA057308
Notice Date: 

This K01 award is designed to provide Dr. Erath with mentored training in implementation science to become an independent investigator focused on advancing the implementation of evidence-based treatments for stimulant use disorder (StimUD) and other substance use disorders (SUDs) in harm reduction and other community treatment and recovery settings. 

The training objectives of this application are threefold: (1) gain proficiency in implementation science theory and research methodology through formal course work, (2) obtain hands-on experiential learning by observing and participating in a seminal statewide implementation of contingency management (CM) treatment for StimUD in California, and (3) develop professional repertoires necessary to be a successful implementation scientist leading an independent research program. Dr. Erath’s multidisciplinary mentorship team is comprised of four nationally recognized independent investigators (Drs. Stephen T. Higgins, Richard A. Rawson, Sara J. Becker, and Kimber P. Richter) with expertise in treatment development for StimUD and other SUDs, implementation science, mentoring early-career investigators, and a successful record of obtaining federal research funding. The proposed research plan seeks to develop hands- on experience and skills in implementation science advancing the use of CM, an evidence-based treatment for StimUD, in community harm-reduction settings using syringe service programs (SSPs) as a model. Despite decades of studies supporting CM’s efficacy for StimUD, its use in community settings is surprisingly limited. To help address this gap, the research plan has three specific aims: (1) conduct a qualitative study examining contextual determinants of implementing CM for StimUD in community SSPs, (2) develop a theory- and partner-informed set of implementation strategies to promote the use and sustainment of CM for StimUD in community SSPs, and (3) conduct a hybrid type 2 pilot feasibility study that simultaneously evaluates the potential efficacy of CM for StimUD in two SSPs and the efficacy of the partner-informed implementation strategies. 

The proposed research is innovative because it represents a substantial departure from the status quo by examining implementation of CM for StimUD in low-barrier harm reduction settings—an emerging and promising setting for SUD treatment. Moreover, the completion of these three aims is significant because it will help address a notable evidence-to-practice gap on the use of a highly effective StimUD treatment in practice, and create a working model, grounded in implementation science, for how to implement CM for StimUD in SSPs that could be adapted and advanced by future research. 

Overall, this K01 award is designed to provide the requisite training and research experience necessary to become a successful implementation scientist, using the obtained knowledge and preliminary findings to open new horizons in advancing the implementation of evidence-based treatments for StimUD and other SUDs in community-based harm reduction and other addiction treatment and recovery settings.

Primary Investigator: Tyler Erath, Ph.D.
Funding Source: National Institutes of Health (NIH)
Grant Type: K Award
Duration: 5 years
Award#: 1K01DA060309
Notice Date: 

Cigarette smoking is a key risk factor for CHD onset and progression. In the United States, cigarette smoking and CHD are both overrepresented among rural Veterans. Prevalence of current smoking among Veterans Health Administration (VHA) enrollees is approximately 12.7%. However, smoking prevalence trends higher among Veterans from states with larger rural (e.g., Vermont; 17.1%) vs. urban populations (Connecticut; 11.28%). Even after controlling for smoking, Veteran status is associated with higher risk for developing CHD, and rural areas experience higher mortality from CHD. Improving smoking cessation among rural Veterans with CHD is a critical endeavor.

Effective smoking interventions are available to both rural Veterans and patients with CHD. Regular counseling and follow-up may require in-person clinic visits, hindering participation for those residing in geographically remote, rural areas and patients with limited physical mobility (e.g., Veterans with service-connected disabilities). Thus, remote methods have been developed to extend evidence-based smoking-cessation treatment to patients with treatment access barriers (e.g., quitline services, text message-based support), and these methods are generally supported by the American College of Cardiology (ACC) and the VHA. Importantly, special considerations need to be made when tailoring smoking-cessation treatment for Veterans with CHD. As a best practice (BP) approach, the VHA recommends a shared decision-making approach wherein VHA healthcare providers make treatment recommendations based on patients’ medical histories and past quit attempts. Unfortunately, despite the readily available, evidence-based treatments for VHA enrollees who wish to quit smoking, <5% of VHA enrollees successfully quit smoking each year. Alternative treatments are sorely needed to improve existing services.

Currently, the VHA currently offers contingency management (CM) for the treatment of substance use disorders other than tobacco (i.e., financial incentives to reinforce biochemically verified abstinence from a target substance). Our group at the Vermont Center on Behavior and Health has demonstrated that CM is a highly effective approach to initiating smoking abstinence in medically vulnerable populations (e.g., pregnant women, patients with pulmonary disease) and is acceptable and efficacious when delivered remotely. To our knowledge, no trials have examined whether CM improves smoking cessation rates for rural Veterans with CHD when added to VHA BP treatment.

The purpose of this research is to conduct a two-arm, parallel-groups, randomized clinical trial (RCT) pilot study to compare two smoking-cessation interventions in rural Veterans hospitalized for a CHD event within the past 3 months: BP (i.e., VHA-informed smoking-cessation counseling, recommended pharmacotherapy, and 3 telehealth follow-up visits over a 3-month treatment period) vs. BP + remote CM to reinforce smoking abstinence. This research involves three aims: (1) examine protocol adherence and treatment engagement across treatment conditions, (2) examine treatment acceptability, including perceived usefulness, ease of use, treatment satisfaction, reasons for dropout, and deviations from treatment protocols, and (3) examine the initial comparative efficacy of BP vs. BP+CM for smoking cessation. Data from this study will support a larger trial and cost-effectiveness analysis.

Primary Investigator: Sulamunn Coleman, Ph.D.
Partner Organization: Veterans Rural Health Resource Center, White River Junction, VT
Funding Source: Veterans Health Administration (VHA) Office of Rural Health (ORH)
Grant Type: Rural Health Career Development Award
Duration: 2 years
Award#: 04246
Notice Date: April 2024