Episode #52 High Truths with Dr. Marta Sokolowska and Stimulant Use Disorder

The Western States are experiencing a greater problem with methamphetamines than with opioids. What are some treatment options for stimulant use disorder? Listen to Dr. Sokolowska who works on this issue for the FDA. Marta Sokolowska, PhD Marta Sokolowska, Ph.D., joined the U.S. Food and Drug Administration in 2018 as Associate Director for Controlled Substances at the Center for Drug Development and Research.  She provides strategic leadership in development and implementation of policies related to controlled substances including advising on all matters related to domestic and international drug scheduling. Dr. Sokolowska is a recognized expert in drug abuse potential assessment and scheduling strategies. Throughout her career she has focused on facilitating initiatives to improve public health by advancing the science of assessing abuse liability. Her past leadership roles include serving as Vice President of Medical and External Affairs at Depomed Inc. and Head of Medical Affairs and the Center for Abuse Prevention and Evaluation at Grunenthal USA. Dr. Sokolowska earned her doctoral degree in psychology from McMaster University in Canada. Learning Points:

• Clinical Trials.gov – This is the website to look up drugs or devices that are waiting for FDA approval
• GPA does not improve by using stimulants for people who do not have a clinical diagnosis of ADHD
• Stimulant misuse often translates to polysubstance misuse.
• An FDA box warning is a warning that appears formatted inside a box at the top of a prescription package insert. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries serious or even life-threatening adverse effects.
• There are 4 steps in New Drug Development according to the FDA. The process can take 10 years.
  1. Discovery and Development – in the lab
  2. Preclinical Research – animal testing
  3. Clinical Research – human testing
  4. FDA Review – approve or not approve
  5. FDA Post-Market Safety Monitoring

This podcast was recorded in February 2021.