Craving as an outcome measure in OUD trials

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Presentation transcript:

Craving as an outcome measure in OUD trials Tanya Ramey MD, PhD NIDA DTMC ACTTION meeting Nov 29 2018

Craving in SUD diagnosis Craving - a key symptom, added into DSM-5 (Criterion 4)- an intense desire or urge for the drug that may occur at any time but is more likely when in environment where the drug previously was obtained or used. Pathophysiology of craving – long term present neuroplacticity signature,and not only in SUDs...

Near-term Goals -Best measure to be identified and validated. -Available craving measures/scales currently used in OUD clinical trials reviewed today. -Best measure to be identified and validated. -Craving Clinical Outcome Assessment (COA) for OUD should go through the qualification process for Drug Development Tool (DDT). This step is needed for: the FDA regulatory acceptability as an endpoint. Label claim? Indication? NIDA is very interested in following FDA Guidances and supporting the development of PROs FDA approved, such as craving.

Clinical Outcome Assessments (COA) Craving Biomarkers Animal Models Clinical Outcome Assessments (COA) Craving NIDA is interested in following FDA Guidance. 4

What is Clinical Outcome Assessment? A measure that produces a score Has clearly defined methods and instruction for administration Has clearly defined methods for assessing responses A standard format for data collection Well-documented methods of scoring, analysis, interpretation of results in targeted patient population

Long term Goals Strive to link Craving COA measure To proximal biological markers, e.g., neurocircuitry To more distal clinical outcomes along the line of how patient feels, functions or survives Use Craving as an intermediate phenotype of incentive salience with the brain function measures biomarkers & behavioral task(s) for efficient go/no-go decisions in drug candidates early clinical evaluation

Clinical Endpoints Endpoints Symptoms State - Trait COAs – clinical scales, eg craving COA Behavioral tasks Human lab measures Brain Circuit malfunction Addictions RDoC RDoC Brain functions measures fMRI, EEG, MEG,…

Addictions RDoC & Craving as an intermediate phenotype increased attention to drug related cues (Kwako et al.,2018)

Thank you for your attention

Clinical Outcome Assessments (COA) Types craving Clinician Reported Outcome (ClinRO) Patient Reported Outcome (PRO) Observer Reported Outcome (ObsRO) Performance Outcome(PerfO) Excludes Biomarkers

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