Clinical Pharmacology Division
Focused on the development, delivery, and efficacy of pharmacological and behavioral interventions for drug addiction and other health-related behaviors.
The Division of Clinical Pharmacology is a leader in tobacco and opioid addiction research and treatment, with over 20 years of continuous NIH funding
- Developing novel medications for tobacco and opioid addiction.
- A long history of research supporting tobacco harm reduction interventions and tobacco control policy.
- Gaining insight into individual differences in vulnerability to drug addiction.
- Developing behavioral treatments to improve health for vulnerable and underserved populations (e.g., individuals with cardiovascular disease and mental health problems, or those experiencing homelessness)
Developing strategies to implement treatments for tobacco dependence into healthcare settings
Clinical Care
Drs. Drew Busch and Paul Pentel provide comprehensive access to evidence-based tobacco cessation treatments. Dr. Sandra Japuntich provides psychotherapy in the Adult Psychiatry Clinic
Education & Training
Our faculty are members of NIH-funded training programs at the University of Minnesota, providing course lectures and trainee mentoring/committee service. They also provide training to healthcare providers in psychotherapy and tobacco treatment. Research in our division provides an excellent context for undergraduate, graduate, and postdoctoral training in drug addiction and other behavioral health problems.
Research
Research in our division is very diverse, spanning studies from in vitro neuropharmacology to clinical trials. Preclinical research is focused on, genetic, pharmacological, and behavioral processes involved in drug addiction and other behavioral disorders. This work has led to novel medications (e.g. vaccines against nicotine and opioids (fentanyl, heroin, oxycodone)) for smoking cessation and reducing opioid use and overdose, some of which are in or nearing clinical trials. Our preclinical research also examines the efficacy and potential adverse consequences of tobacco harm reduction interventions (e.g. smoking reduction, nicotine replacement therapy) and regulatory standards for tobacco products (e.g. nicotine reduction). Genetic and behavioral risk factors for vulnerability to tobacco and opioid addiction are another preclinical research focus.
Clinical research in our division is focused on clinical trials of behavioral treatments that consider the dynamic interaction of mental health, physical health, and health behavior. Particular attention is on providing these treatments in modalities and settings that increase access to behavioral health care for underserved communities. The lab conducts behavioral and implementation clinical trials with a variety of targets (e.g. tobacco cessation, health behavior change, mood management) in a variety of populations.
More details about our research activities can be found here:
Clinical Pharmacology Division Faculty
The division comprises six faculty, three are dedicated to clinical care and research, and the others conduct preclinical research.
Andrew Busch, PhD, LP
Associate Professor of Medicine, University of Minnesota Medical School
Director, Tobacco Dependence Clinic, Hennepin Healthcare
Co-Director, Behavioral Health Equity Research Group, Hennepin Healthcare Research Institute
Dr. Busch is a Senior Psychologist in the Hennepin Healthcare Department of Medicine, Division of Clinical Pharmacology and leads the Hennepin Healthcare Tobacco Dependence Clinic. He is also an Associate Professor of Medicine at the University of Minnesota Medical School. Dr. Busch’s current work includes 1) efforts to understanding physical health disparities among those with mental illness, 2) developing interventions that target improvement in both mental and physical health, and 3) developing counseling interventions to improve physical health among our most underserved communities. Dr. Busch is an expert in Behavioral Activation-based counseling and applies this treatment in many of his ongoing studies.
Education and training
- Clinical internship and Fellowship in Psychiatry, Brown University Medical School, Providence, RI
- PhD in Clinical Psychology, University of Wisconsin, Milwaukee WI
Recent Publications
Grants
- R01AG077989 (NIH/NIA): Optimization of a behavioral intervention to increase physical activity in older adults living with HIV. 9/1/2022-8/31/2027; Co-Investigator
- R03DK133553 (NIH/NIDDK): Expanding the Diabetes Homelessness Medication Support (D-Homes) program to Spanish-speaking Hispanics. 8/5/22-7/31/2024; Co-Investigator
- PCS2021C1-22396/NCT05546697 (PCORI): Expanding First-Line Options for Depression & Matching Treatments: Hatha Yoga vs. Behavioral Therapy. 4/1/22-3/31/27; Role: Co-I and Site-PI
- R01MH119919 (NIH/NIMH): Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients; 9/1/2021-11/30/2023; Co-I and Site-PI
- P50MD017342 (NIH/NIMHD): Center for Chronic Disease Reduction and Equity Promotion Across Minnesota (C2DREAM). 9/24/2021-6/30/2026; Role: Co-Director of Investigator Development Core; Co-I on Project 3
- SAMHSA State Opioid Response Grant/MN DHS: Strengthening Integrated Clinical Services for Opioid and Stimulant Use Disorders in Family Medicine Training Clinics: 6/7/2021-9/29/2022; Consultant
- UG1DA040316 (NIH/NIDA): NorthStar Node of the Clinical Trials Network: 6/1/2020 – 5/31/2025; Co-Investigator
- K23DK118117-S1 (NIH/NIDDK): Administrative diversity supplement to Improving medication adherence among people with diabetes who are homeless: 9/1/2020-8/31/2022; Primary Mentor on Parent Award.
- 1U01DK123816 (NIH/NIDDK): The Hemodialysis Opioid Prescription Effort Consortium: 09/24/2019-05/31/2024; Co-Investigator
- K23DK118117 (NIH/NIDDK): Improving medication adherence among people with diabetes who are homeless: 3/28/2019-12/31/2023; Primary mentor
- R01HL136327 (NIH/NHLBI): Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management: 8/18/2017-4/30/2023; Principal Investigator
Teaching Activities
Seminars on smoking cessation to residents.
Mark LeSage, PhD, Division Co-Director
Professor of Medicine, University of Minnesota Medical School
Associate Professor, Departments of Pharmacology and Psychology, University of Minnesota
Senior Investigator, Hennepin Healthcare Research Institute
Dr. LeSage has been an investigator at the Hennepin Healthcare Research Institute and faculty in the Division of Clinical Pharmacology for 22 years. He has been Director of the Division since 2018. His training is in experimental psychology, with an emphasis in behavioral pharmacology. His research generally focuses on employing animal models to address vital issues related to tobacco harm reduction and FDA regulation of tobacco products, such as examining the abuse liability of tobacco products and examining how various chemicals in tobacco contribute to the addictiveness of tobacco products. Another primary focus of his work is on the development of immunotherapies (e.g., vaccines) and other medications to treat tobacco and opioid addiction.
Education and training
- Postdoctoral fellowship, Louisiana State University Medical Center, Shreveport, LA
- PhD, Psychology, Western Michigan University, Kalamazoo, MI
- MA, Psychology, Western Michigan University, Kalamazoo, MI
- BS, Central Michigan University, Mount Pleasant, MI
Recent Publications
Grants
R01 DA048899 (NIH/NIDA): Comparative neurobehavioral pharmacology of combusted and non-combusted tobacco products. 07/15/20-05/31/25. Multiple Principle Investigator (contact, PI)
BAA-DAIT-75N93020C00039 (NIH/NIAID): Development of Vaccines for the Treatment of Opioid Use Disorder. 09/30/20-08/31/25. Site Principle Investigator
UG3DA048386 (NIH/NIDA): Vaccines for fentanyl and its derivatives: A strategy to reduce illicit use and overdose. 10/01/19-12/31/26. Site Principle Investigator
U01DA051993 (NIH/NIDA): Identifying genomic loci related to vulnerability to opioid addiction. 08/01/2020 – 05/31/2025. Co-Investigator
R01DA046318 (NIH/NIDA): Animal models to inform FDA tobacco regulation: Assessing the relative abuse liability of different classes of tobacco products. 09/01/18-08/31/22. Multiple Principle Investigator
R01-DA04525 (NIH/NIDA): Targeted Tobacco Regulatory Science: Nicotine Dose Effects in Animal Models of Smoking Initiation in Vulnerable Adolescent Subpopulations. 08/15/16-05/31/21. Principle Investigator
Teaching Activities
Lecturer. PSY 8061/PHCL 8208, Neuropsychopharmacology, Departments of Psychology and Pharmacology, University of Minnesota.
Lecturer. NSC 5462/PHCL 5462, Neuroscience Principles of Drug Abuse, Departments of Neuroscience and Pharmacology, University of Minnesota.
Undergraduate, Graduate, and Postdoctoral research training/mentoring
Other Key Professional Activities
Chair, Institutional Animal Care and Use Committee (IACUC), Hennepin Healthcare Research Institute.
Consultant (Special Government Employee), Food and Drug Administration, Center for Tobacco Products, Silver Spring, MD.
NIH/NIDA Ad hoc study section member.
Journal referee. Drug and Alcohol Dependence, Nicotine and Tobacco Research, Journal of Pharmacology, Neurotoxicology and Teratology, Science, and others.
Lynn Andreae, PhD
Post-Doctoral Research Fellow, Hennepin Healthcare
Dr. Andreae earned an MPH in health behavior and a PhD in health education and health promotion at the University of Alabama at Birmingham. Prior to joining Hennepin Healthcare, she worked on programs to improve diabetes and hypertension self-management through telephone-delivered peer support. She also worked on programs that provided quality-improvement support to primary care practices to improve hypertension management and tobacco use screening and cessation treatment.
Education and training
- PhD, School of Public Health, University of Alabama, Birmingham, AL
- MA, University of Alabama, Birmingham, AL
- BA, University of Alabama, Birmingham, AL
Andrew Harris, PhD
Associate Professor of Medicine, University of Minnesota Medical School
Adjunct Associate Professor, Department of Psychology, University of Minnesota
Graduate Faculty Member, Graduate Program in Neuroscience and Department of Pharmacology, University of Minnesota
Senior Investigator, Hennepin Healthcare Research Institute
Dr. Harris has been at the Hennepin Healthcare Research Institute (HHRI) / Minneapolis Medical Research Foundation (MMRF) since September 2005 in several research-related roles ranging from postdoctoral fellow to my current position as Senior Investigator. His research broadly involves the use of preclinical models to characterize behavioral and neurobiological factors underlying addiction to nicotine, opioids, and other drugs of abuse. Specific areas of interest include a) characterization of the abuse liability of tobacco constituents other than nicotine (for example, minor tobacco alkaloids) in order to inform FDA regulation of tobacco products; b) identification of behavioral predictors and molecular mechanisms underlying individual differences in addiction vulnerability; c) neurobiological and behavioral consequences of prenatal drug exposure; and d) development of novel pharmacotherapies for addiction (for example, vaccines and monoclonal antibodies).
Education and training
- Postdoctoral Fellow, Minneapolis Medical Research Foundation (now Hennepin Healthcare Research Institute), Minneapolis, MN
- PhD, Psychology, University of Minnesota, Minneapolis, MN
- BS, Psychology, University of Wisconsin, Eau Claire, WI
Recent Publications
Grants
- U01 DA051993 (NIDA): Identifying genomic loci related to vulnerability to opioid addiction; 2020 – 2025. Multiple Principal Investigator.
- RO1 DA048899 (NIDA): Comparative neurobehavioral pharmacology of combusted and non-combusted tobacco products; 2020 – 2025. Multiple Principal Investigator.
- Contract BAA-DAIT-75N93019R00009. (NIAID): Development of vaccines for the treatment of opioid use disorder; 2020-2024. Co-Investigator.
- R01DA053608 (NIDA): An evaluation of Beta-nicotyrine as a potential contributor to the abuse liability of e-cigarettes. 2021 – 2023.
- Seed grant, U of M Masonic Institute for the Developing Brain (MIDB): A translational approach for establishing serum-based biomarkers of the neurobehavioral consequences of prenatal opioid exposure; 2022 – 2024. Multiple Principal Investigator (Contact PI).
Teaching Activities
- Course director/instructor. Neuropsychopharmacology (PHCL 8208/PSY 8061/NSC8208), U of M.
- Guest lecturer. Freshman seminar: Brain Science, Drugs, and Society (PSY 1912), U of M.
- Guest lecturer. Substance Abuse at the Bedside (PSY 1912), U of M
Other Key Professional Activities
- Chair, HHRI Institutional Biosafety Committee.
- Member, U of M Institutional Biosafety Committee.
- Member, Executive Committee. U of M PharmacoNeuroImmunology (PNI) Training Program
- Associate Editor, Nicotine and Tobacco Research. Basic Science emphasis.
Sandra Japuntich, PhD
Associate Professor of Medicine, University of Minnesota Medical School
Clinical Psychologist/Investigator, Hennepin Healthcare
I joined Hennepin Healthcare in 2019. I work both in the Department of Medicine and the Department of Psychiatry. My research focuses on developing, testing, and implementing strategies for addressing tobacco use and tobacco-related diseases in healthcare settings. In addition, I am a provider in the Adult Psychiatry clinic providing trauma-informed mental health treatments.
Education and training
- Behavioral Medicine Fellowship, Massachusetts General Hospital/Harvard Medical School, Boston, MA
- Clinical Psychology Internship, The Alpert Medical School of Brown University, Providence, RI
- PhD, Clinical Psychology, University of Wisconsin, Madison, WI
- MS, Clinical Psychology, University of Wisconsin, Madison, WI
- BA, Psychology & Spanish, University of Wisconsin, Madison, WI
Recent Publications
Grants
- 4UH3DE029973 (NIDCR): Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices 08/05/22-07/31/25; PI
- P50MD017342 (NIMHD): Center for Chronic Disease Reduction and Equity Promotion Across Minnesota (C2DREAM); 09/24/2021 - 06/30/2026; Project 2 Co-Lead
- 1 R34 DA046078-01 (NIDA): Implementation of Cessation Treatment in Community Based Mental Health Centers; 12/1/19-11/30/22; PI
- 1R01HL136327-01 (NHLBI): Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management; 8/18/2017-7/31/2022; Co-I
- 1 R44 DA048668-01(NIDA) QuitBet: A Digital Social Game that Pays You to Stop Smoking; 7/1/19-3/31/22; Co-I
Teaching Activities
- Postdoc Mentor- C2DREAM
- Mentor, Rockswold Scholar’s Program
- Mentor, Pathways to Research Program
- Mentor, Health Disparities in Cancer T32
- University of Massachusetts Tobacco Treatment Specialist Trainer
Other Key Professional Activities
- Review committee member, American Cancer Society Healthcare Outcomes, Policy and Systems Research
- Director, Office of Women’s Careers, HHRI
- ADHD treatment team, Hennepin Healthcare Psychiatry
Paul Pentel, MD
Professor of Medicine, University of Minnesota Medical School
Division Director, Clinical Pharmacology 1996-2018, Hennepin Healthcare
Director, Tobacco Clinic 1986-2018, Hennepin Healthcare
Education and training
- Clinical and Experimental Pharmacology Fellowship, University of California, San Francisco, CA
- Internal Medicine Residency, Hennepin County Medical Center, Minneapolis, MN
- MD, Stanford Medical School, Stanford, CA
- BA, New York University, Bronx, NY
Recent Publications
Grants
- 4UH3DE029973-03 (NIDCR): Effectiveness of nicotine replacement therapy sampling in dental practices 8/5/22 – 7/30/25 Consultant (S. Japuntich PI)
- R01 DA048899 (NIH/NIDA): Comparative neurobehavioral pharmacology of combusted and non-combusted tobacco products.07/15/20-05/31/25. Collaborator (M. LeSage, A. Harris PIs)
Teaching Activities
Teaching residents in the Tobacco Clinic and ad hoc resident/staff talks
John (Jack) Smethells, PhD
Research Associate, Department of Medicine, University of Minnesota Medical School
Investigator I, Department of Medicine, Hennepin Healthcare Research Institute
Education and training
- Pharmaco-Neuro-Immunology Fellowship, University of Minnesota, Minneapolis, MN
- Investigator I, Department of Medicine, Hennepin Healthcare Research Institute
- Ph.D. & MS Applied Experimental Psychology, Central Michigan University, Mount Pleasant, MI
- BS Psychology, University of Wisconsin, Eau Claire, WI
Recent Publications
Grants
- R03DA045981 (NIDA): Behavioral economic modeling of tobacco and alcohol co-abuse liability; 9/01/2019 – 8/31/2020; Principal Investigator
- R01DA053608 (NIDA/CTP): An evaluation of beta-nicotyrine as a potential contributor to the abuse liability of e-cigarettes; 9/01/2021 – 8/31/2024; Principal Investigator
Teaching Activities
PSY 8061/PHCL 8208, Neuropsychopharmacology, Departments of Psychology and Pharmacology, University of Minnesota
Other Key Professional Activities
Grant reviewer for NIH special emphasis panel ZRG1 IFCN-E (56)