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J Clin Exp Tox 2017 | Volume 1 | Issue 2
Toxicology and Pharmacology
November 01-02, 2017 | Toronto, Canada
International Conference on
Evaluating the abuse potential of CNS active drugs: Regulatory and methodological considerations
Beatrice Setnik
1, 2
1
INC Research, Canada
2
University of Toronto, Canada
P
rescription drug abuse continues to be a great concern and
regulatory agencies such as the FDA and Health Canada
require abuse potential evaluation to inform appropriate
drug scheduling for novel CNS-active drugs at the time of
drug approval. One of the required studies includes the
human abuse potential study (HAP). HAP studies are a type
of clinical study evaluating subjective and objective drug
effects related to abuse potential and drug impairing effects.
The preferred design is a randomized, double-blind, placebo-
and positive-controlled crossover study. The studies are
generally conducted in drug-experienced, non-dependent
recreational drug users who have a past and recent history
of using a drug in the pharmaceutical class of the test drug.
Generally, these studies are considerably distinct compared
to healthy volunteer and patient studies, and host their own
complexities and challenges. The drug using population
represents a unique subgroup requiring adaptions to clinical
trialmethodology. Challengeswith thesepopulations include,
but are not limited to, compliance with restrictions around
concomitant medication and drug use, risk-taking behavior,
and prior addictive disorders. The population needs to be
carefully selected and screened to ensure that safety is not
compromised, eligibility requirements are met, appropriate
discrimination between the active control versus placebo is
established, and that subjects are able to comply with the
study requirements. Furthermore, a population using drugs
by a specific route (e.g. intranasal, intravenous) may be
needed if the clinical trial intends to study unintended routes
of administration, as is often the case in studies evaluating
abuse-deterrent formulations. Understanding the profile
and nature of the population and the study requirements
ensures appropriate rigidity in the methods and conduct of
such studies. This session will provide an overview of the
key regulatory and clinical methodological considerations in
conducting HAP studies.
Speaker Biography
Beatrice Setnik has been working in the area of CNS research, clinical drug development
and abuse potential assessment for over 16 years and is an expert in the area of abuse
liability evaluation. She is currently the Vice President of Scientific and Medical Affairs
at INC Early Phase and an Adjunct Professor with the Department of Pharmacology
and Toxicology at the University of Toronto. She earned her Doctorate degree in
Pharmacology and the Collaborative Program in Neuroscience from the University of
Toronto in 2005.
e:
Beatrice.Setnik@INCResearch.com