Characterizing human abuse potential (HAP) liability can be dependent on many factors, including pharmacology, pharmacokinetics, and the intended population. At CenExel HRI, our scientific and medical teams have extensive expertise in clinical study design methodology, dose selection, and subject screening and selection criteria, as well as regulatory agency experience that can support your protocols and prepare Sponsors for their review with the FDA’s Controlled Substance Staff (CSS). The CenExel HRI team has provided HAP clinical development and regulatory advice to Sponsors from pre-IND to NDA. The team has an outstanding track record of success in characterizing human abuse potential liability through conducting trials assessing the abuse potential of drugs.
What capabilities do we offer?
A purpose-built 60-bed inpatient unit. CenExel HRI’s clinical and medical teams have extensive experience in the evaluation and screening of recreational drug users for inclusion in HAP studies at the Marlton, NJ location (just twenty minutes from Philadelphia)
Scientific and Medical staff that are experienced in the assessment and characterization of behavioral and cognitive adverse events, key to successful HAP studies
Effective collaboration with respective vendors to ensure attainment of high-quality data and drug/placebo separation
Proprietary, empirically grounded Placebo-Control Reminder Script (PCRS) to further mitigate placebo response, which helps decrease study completion timelines
Medical and Clinical teams are trained in the evaluation and management of substance withdrawal
Capnography/pulse oximetry, pupillometry, and biophysical testing
Pharmacy facilities that supports Schedule I-IV drug storage
What about recruitment?
Large research database of recreational drug users including opioids, hallucinogens, stimulants, psychedelics, and benzodiazepine populations
15+ full-time recruitment specialists including Director of Recruitment with 15 years’ experience recruiting for HAP studies and substance use trials
Location in major metropolitan region that is home to over 30 colleges and universities
What are CenExel HRI’s retention capabilities?
Highly skilled medical team determining eligibility of participants for the trial (e.g., recreational use vs. DSM-5 substance use disorders)
Recruiters provide timely reminders about participants’ next visits during all study visits of the trial
Dedicated full-time drivers to transport subjects to and from the research site
Principal Investigators with decades of substance abuse clinical experience
A clinical psychologist with specialization in addiction and pain who has served on advisory boards for addictions studies and that has experience co-writing HAP protocols and risk mitigation
Advanced degree-level raters highly experienced with HAP assessment scales
Pharmacy Director with expertise in preparing, dispensing, and dosing HAP trials
Scientific Affairs & Clinical Development team providing high-level scientific guidance and input on study designs, protocols, assessment measures, and medical/scientific feasibility