Human Abuse Potential HAP

A variety of compounds that affect the central nervous system have the potential to produce dependence, tolerance, addiction and other negative consequences associated with substance abuse. Human Abuse Potential studies were developed to assess these risks, and these clinical trials are critical to determine the scheduling of a drug under the US Controlled Substances Act.

Lotus has leveraged the growth of its expertise, regulatory experience, and services in analgesics to partner with biopharmaceutical companies to conduct clinical trials involving investigational agents for acute and chronic pain indications. Our clients are often seeking to develop treatment options for the more than 50 million pain patients, including postoperative pain. The goal is finding treatments that do not put these patients at risk for addiction. Lotus understands the importance and unique challenges of running these Human Abuse Potential trials in patients who are recreational users. Lotus has ready access to this subject population and possesses the experience to execute these studies efficiently and safely.  In addition to extensive experience with administering fentanyl infusions, recent studies conducted across the Lotus-ERG group have included a variety of investigational and FDA-approved analgesics and other compounds, including oxycodone, morphine, hydrocodone, hydromorphone, tramadol, dextromethorphan, and ketamine.  Routes of administration include oral, intranasal, and intravenous (e.g., ketamine).

“There is tremendous need among individuals who suffer from acute and chronic pain for improved therapies that do not carry the well-established risks inherent with traditional opioids.”

Any new drug that has the potential to target sites or permeate the central nervous system requires an assessment of its abuse and dependence liability.  Lotus has historically focused the growth of its services, expertise, and regulatory knowledge in analgesics to successfully partner with biopharmaceutical companies to execute clinical trials across acute and chronic pain indications. Each of our pain clients are looking for a treatment option for the more than 50 million Americans that suffer from chronic pain, and exponentially more that will endure acute pain from surgical procedures without falling victim to addiction. The importance of Human Abuse Probability (HAP) research is not limited to analgesics, but it has given Lotus and our Sponsors a huge advantage in quickly and effectively running these important trials. Lotus, along with our affiliated nationally recognized and respected site in Ohio (Ohio Clinical Trials, or OCT) understand the unique challenges of this type of trial. Human abuse potential studies run in patients who are nondependent recreational opioid users, assess drug likeability at high doses, above the therapeutic range. Lotus and OCT have almost immediate access to this patient group and can enroll these studies faster than any other CRO.