The abuse of prescription drugs has become a serious health concern for healthcare providers, drug manufacturers and governmental regulators. According to the National Institute on Drug Abuse, an estimated 48 million people in the United States have used prescription drugs for non-medical reasons.
Under the direction of Chief Medical Director, Lynn R. Webster, MD, our highly trained HAL clinical team in Salt Lake City is the leader in the Human Abuse Liability (HAL), leading in study design, management and execution of these complex clinical investigations. The strong scientific team displays a depth of understanding of current regulatory guidance for assessing the relative abuse potential of NCEs, current CNS drugs and those in the CNS pipeline.
The HAL team in Salt Lake City has an ongoing and continued commitment to regularly interact with the US FDA on abuse liability topics of focus and consistently meets or exceeded enrollment deliverables in each successfully conducted HAL project.
Dr. Webster is Board Certified in Pain Medicine and certified in Addiction Medicine. His clinical expertise and research interests are at the crossroads where abuse liability, and the shadow it casts on medical practice, is having the greatest impact on patient care.
Dr. Webster published a book in 2007 Avoiding Opioid Abuse While Managing Pain to aid practitioners in managing this global problem
Dr. Webster published article: Research design consideration for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations
Studies include a key component in a milestone 2008 NDA submission (EMBEDA™ (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use - CII ). A landmark approval was granted in August 2009 of this first drug product to contain labeling information regarding abuse liability. The inherent value of this information and our continued contribution to HAL projects is of paramount importance to our HAL clients and to prescribing physicians.
The CRI Lifetree Difference
CRI Lifetree Salt Lake City has more experience and has conducted more abuse liability assessments than any in the US.
Our Center of Excellence in Salt Lake City, Utah is recognized internationally by global regulatory authorities. We have a large database of recreational drug users, ensuring that subjects are enrolled rapidly and efficiently.