Event Summary:
A one-day workshop organized by the Center for Interdisciplinary Research and
Consulting at the University of Maryland, Baltimore County (UMBC), and the
Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.
Registration is now closed
⇒View Archives here⇐
Organizing Committee:
Faculty from UMBC and Stanford University and leaders from FDA and industry.
For more information:
Please contact Dr. Yi Huang, Department of Mathematics and
Statistics, University of Maryland Baltimore County (UMBC),
1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.
For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.
Participant Information
Ivan Montoya from National Insitute on Drug Abuse.
Paper: Drug Safety Assessment in Drug Abuse Clinical Trials
The assessment of the medical safety of study participants in clinical trials of medications to treat substance use disorders (SUDs) can be challenging because the disorders themselves are largely due to untoward effects of illicit drugs or medications. Therefore, it is critical to assess the effects of the compound in individuals with the SUD who are or are not using the substance of abuse. Phase I clinical trials often involve the co-administration of the investigational medication and different drugs of abuse to determine if they have synergistic effects or other pharmacological interactions. Moreover, the safety assessment of any pharmacotherapy for SUD requires a thorough evaluation of its abuse potential because individuals with SUDs will be at risk of acquiring new drug addictions and develop poly-substance use disorders. Phase II and Phase III clinical trials are also challenging because of the clinical characteristics of the disorders. For example, SUDs are associated with antisocial behaviors, homicidal or suicidal behaviors, poor treatment compliance, high risk of accidents, immunosuppression, infections, and cognitive impairments. Investigators have been able to overcome these challenges and develop safe and effective medications that are approved by the FDA for SUD. This presentation will review the drug safety assessment process in Phase I, II and III clinical trials of medications to treat SUDs.