Abuse liability assessments: Self-administration
A self-administration study assesses the potential of a drug to maintain lever-pressing behavior due to its positive reinforcing effects.
If the test drug produces a high level of self-administration compared to vehicle, there is a good probability that the drug will produce rewarding properties in humans that are supportive of drug abuse.
The intravenous route of administration should be used to optimize the temporal association between active lever-pressing and immediate drug effects.
This study type is conducted for the purpose of assessing the rewarding and reinforcing potential of a test agent and forms part of the regulatory required abuse liability assessment for CNS active drugs.
Abuse-related nonclinical studies must be conducted using GLP, as these are nonclinical laboratory studies that support approval of a drug for use in humans.