Subjects of human abuse potential (HAP) studies must be able to detect liking with the investigational drug. However, many subjects recruited for HAP studies use marijuana, and THC is often exempt from exclusion by urine drug tests (UDTs). PRA Health Sciences examined whether UDT evidence of recent marijuana use was associated with a difference in subjects’ ability to discriminate opioid from placebo. Successful opioid discriminators were associated with a statistically insignificant, but higher positive THC UDT rate and mean carboxy-THC urine concentration when compared to non-discriminators, indicating that recent users of marijuana may not need to be excluded from opioid HAP studies.
Clinical Trials in Children with Impaired Mental Capacity
Download this resource to learn how to conduct studies with patients who lack legal competence and the 4 ethical pillars of medical research.
Predicting Screen Failure Rates of Human Abuse Potential Studies
Human Abuse Potential (HAP) studies are required for New Drug Approvals of all drugs that have a potential psychoactive effect. The steps of…
Pharmacogenomics in Pain Management
Pharmacogenomics in Pain Management. In the US alone there are an estimated 100 million adults suffering from chronic pain. Pharmacogenomics and…