Substance Use Disorder & Abuse Liability
A thorough assessment of abuse liability is a critical part of the nonclinical safety evaluation of any new compound that directly or indirectly targets the central nervous system. Transpharmation provides all required in vivo pharmacology services for abuse liability assessment in support of the regulatory submission of novel compounds. In addition, Transpharmation provides efficacy testing aimed at evaluating whether a novel compound is effective in reducing the reinforcing, motivational, and adverse effects of known drugs of abuse.
Models
Safety studies provide a behavioral profile of a novel compound and compare it to that of a known drug of abuse. Efficacy studies test the ability of a novel compound to alter the behavioral effects of a known drug of abuse.
Read the full description: General behavior and locomotor activity
Place conditioning assesses the motivational effects of compounds including reward and aversion. Safety studies examine the motivational effects of a novel compound, while efficacy studies assess the ability of a compound to modulate the rewarding and aversive effects of drugs of abuse.
Drug discrimination studies assess whether the interoceptive effects elicited by a substitution drug are similar to that of a training drug. In safety studies, the degree to which a novel compound substitutes for a known drug of abuse is evaluated. In efficacy studies, the ability of a novel compound to modulate the interoceptive effects elicited by a known drug of abuse is assessed.
Self-administration is the gold standard for assessing reinforcement. Self-administration studies assess voluntary consumption of a compound. Safety studies examine the ability of a novel compound to maintain operant responding for drug delivery compared to vehicle and a drug of abuse from the same class or therapeutic category. Efficacy studies evaluate whether a novel compound can reduce reinforcement of a known drug of abuse.
Withdrawal symptoms are adverse effects elicited by termination of drug exposure following chronic administration and can be dangerous and/or lead to increased drug-seeking behavior. In safety studies, the adverse effects elicited by termination of exposure to the novel compound following chronic exposure are evaluated. In efficacy studies, the ability of a novel compound to attenuate withdrawal symptoms elicited by other compounds is assessed.
Relevant services
Platforms used in this area
Safety Studies Tolerability across species
Electroencephalography (EEG) In-vivo rodent telemetry
Operant Platform Motivation, impulsivity, attention, cognition, memory
PK/PD Studies Endpoints for lead optimization
PK-Bridge PK studies for discovery budgets
Cognitive Assessment Aged-dog memory and cognitive decline
Transgenics Genetically modified mice
Have a program in mind?
Talk to a Transpharmation researcher about your study design and timelines.