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2018 Accomplishments
Dr. Lofwall continues to spend the majority of her time conducting clinical research. The research highlight this past 2018 was the publication of a pivotal study as P.I. for a 36-site Phase III randomized double-dummy double-blind outpatient clinical trial evaluating the efficacy and safety of subcutaneous buprenorphine weekly and monthly injections (CAM2038) among adults with moderate – severe opioid use disorder. The results were positive demonstrating non-inferiority to the current standard treatment. The FDA will make a decision about approval of the medication by the end of December 2018. Dr. Lofwall is involved in several other research studies. She is the co-investigator and medically responsible physician on several NIDA-funded outpatient and inpatient clinical studies with (PI’s: Walsh, Knudsen, Havens, Staton, Fanucchi, Ashford). She also works on a Dept. of Justice grant (PI: Svetla Slavova, Ph.D.) utilizing state prescription monitoring program data to monitor gabapentin prescribing and effects of recent legislation incorporating drug convictions on prescribing reports. Dr. Lofwall continues to work on the executive protocol development team for a NIDA CTN study 0080 to evaluate CAM2038 in pregnant opioid addicted women – the protocol is now under FDA review. She submitted a new R01to NIDA as multi-PI with Dr. Fanucchi to evaluate integrated outpatient infectious disease treatment with opioid use disorder treatment among adults needing long course of intravenous antibiotics. She also worked on the NIDA HEAL application (Walsh PI) that aims to decrease opioid overdose deaths in 17 KY counties over three years. Dr. Lofwall continues to serve as the Bridge Clinic medical director, which now has providers serving patients every weekday helping to grow clinical services as part of UK Healthcare’s new investment in addiction medicine. She also continues as Medical Director of the Straus Clinic. In 2018, Dr. Lofwall has 8 peer-reviewed publications in highly respected journals (e.g., JAMA Internal Medicine) with several more in press and was an expert panel writer for the new national guidelines and toolkit from SAMHSA on medical treatments for opioid use disorder “Treatment Improvement Protocol for Medication Treatment of Opioid Use Disorder (TIP 63)”. With regards to public and professional society service, Dr. Lofwall continues as the co-course director for the annual 3.5 day addiction psychiatry review course for AAAP, provided several buprenorphine trainings in KY, served as a grant reviewer for NIDA, mentor for SAMHSA funded Physician Clinical Support System for Medication Assisted Treatment [PCSS-MAT]), trainer for the SAMHSA funded State Targeted Response Technical Assistance Consortium, and served as an invited expert panel member on opioid use disorder treatment to the National Academy of Medicine. She continues also to serve on the ASAM board. Dr. Lofwall continues to serve the educational mission of UK as well. She is on the dissertation committee for several Ph. D. students, mentors junior faculty, teaches medical students (MD-813), physician assistant students (PAS-655), dental pain fellows and provides weekly individual psychiatry resident supervision. She also was honored with becoming the second Bell Alcohol and Addictions Endowed Chair.