2017 Accomplishments   

Dr. Lofwall continues to spend the majority of her time conducting clinical research. The highlight this past 2017 was analysis 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.  Dr. Lofwall presented at FDA Advisory Committee hearing for this medication.  The committee voted in favor of approval, and the FDA will make its decision in January 2018.  

 Dr. Lofwall is involved in several other research studies.  She is the co-investigator and medically responsible physician on NIDA-funded outpatient and inpatient clinical studies with (PI’s: Walsh, Knudsen, Havens). She also is working on an AIDS United funded research project integrating buprenorphine treatment into HIV primary care (PI: Laura Fanucchi, MD – one of Dr. Lofwall’s mentees) and 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.  She has initiated new research collaborations with the College of Nursing (Kristen Ashford, APRN) and together they designed and wrote a pilot RCT NIDA (R34) that was just scored – 20.  Dr. Lofwall and Theresa Winhusen, Ph.D. (Univ. of Cincinatti) also proposed a NIDA CTN study to evaluate CAM2038 in pregnant opioid addicted women – this was viewed favorably but is pending budget determinations.  She worked with Drs. Walsh and Fanucchi successfully on an application for CURES funding to initiate a bridge clinic for adults with opioid addiction presenting to the ER with overdose and other complications of drug use.  They are now working on building this program along with more clinical services as part of UK Healthcare’s new investment in addiction medicine.

In 2017, Dr. Lofwall has 11 peer-reviewed publications in highly respected journals (e.g., JAMA Psychiatry) and was an expert panel writer for the soon to be published national guidelines and toolkit from SAMHSA on medical treatments for opioid use disorder (ordered by Congress as part of CARA legislation).  She presented her research at international and national meetings (e.g., American Society and International Society of Addiction Medicine [ASAM & ISAM]), was also asked to teach in Germany at the Improving Outcomes in the Treatment of Opioid Dependence Conference.       

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, and served as a grant reviewer for NIDA and mentor for SAMHSA funded Physician Clinical Support System for Medication Assisted Treatment [PCSS-MAT]).  She serves on the ASAM scientific program committee and is on the ASAM board. Dr. Lofwall also continued service as an elected member to the Governor’s Kentucky All Schedule Prescription Electronic Reporting Advisory Council (second term) and volunteered to educate KY Public Defenders in Appalachia on opioid addiction treatments in a half-day course.

Dr. Lofwall continues to serve the educational mission of UK as well.  She is on the dissertation committee for four Ph. D. students, mentors two junior faculty, teaches UK psychiatry residents, medical students (MD-813), physician assistant students (PAS-655), dental pain fellows and provides weekly individual psychiatry resident supervision. She also continues working on a team led by Dr. Fanucchi to assist with development of hospital protocols for opioid withdrawal and initiation of maintenance treatment and treatment of pain among persons maintained on buprenorphine.