Ten Things You Need To Know About Conducting A Human Abuse Liability Study

Tips about the HAL Study from Dr. Lynn Webster, medical director of CRI Lifetree and president-elect of the American Academy of Pain Medicine

1) Why are Human Abuse Liability (HAL) Studies required by the FDA?
HAL studies are required by the FDA to evaluate the abuse  liability of drugs in development and to determine the relative risk of abuse before a drug comes to market. The results of these studies help the FDA and the sponsor determine risk management strategies to mitigate these risks and help in the determination of the product’s schedule.

2) What population should be included?
As described in the draft guidance, “Assessment of Abuse Potential of Drugs,” HAL studies should be conducted in people who have experience with recreational drug use, have a recent or current history of using a drug in the same pharmaceutical class, and who have experience with drugs with similar psychoactive properties. However, people who have a current diagnosis of substance dependence or are currently in treatment for a substance-related disorder should be excluded. The reason the FDA recommends enrolling these people is that they are better able to identify subtle differences in the drug effects that are known to be relevant to abuse assessment, such as likability and euphoric effects.