Human Abuse Potential
Altasciences has conducted over 40 human abuse potential (HAP), abuse deterrent formulation (ADF), or substance abuse studies since 2008, including through repeated multi-year contracts with the NIH and the FDA. HAP studies may be required by the FDA as part of the safety evaluation for New Chemical Entities (NCEs) that are CNS-active, chemically or pharmacologically similar to other drugs with known abuse potential, or produce psychoactive effects such as sedation or euphoria. ADF trials are often pursuant to a 505(b)(2) or Hybrid strategy. The complicated regulatory pathway for HAP and ADF protocol designs (selection of comparator, recruiting, etc.) requires individualized consulting for each type of study.
Our physicians work with both recreational drug users and substance-dependent participants, and have significant expertise in the identification of appropriate subjects for substance abuse studies. We have the specialized pharmacy facilities and locations to ensure appropriate manipulation of many abuse-deterrent formulations.
Our clinical sites have robust databases of recreational abusers of opioids, stimulants, sedative hypnotics and cannabinoids, including abuse by oral, parenteral or nasal routes. Our upscale facilities contribute to industry-leading retention rates for up to 60 days of consecutive confinement.
Altasciences’ adaptive clinical pharmacology unit in Kansas City provides a highly reconfigurable and adaptable space for conducting complex clinical trials with challenging subject populations. The 30-bed locked, limited-access, self-contained unit allows sponsors to control every aspect of the study environment as it relates to the special needs of the unique study population or the specific requirements of the protocol, and makes it possible for them to obtain key efficacy data earlier in their development process.
We partner with Cambridge Cognition for VAS scale collection for pharmacodynamic measures, such as drug liking. Our experienced clinical staff is retrained on use of the tablet-based software before each study. We also educate participants on system use and relevant details, such as the difference between unipolar and bipolar scales. We ensure there is a 1:1 staff to participant ratio during the collection of this vital data.
- Large database of recreational drug users
- 40+ abuse potential or substance abuse studies over the last decade
- 1:1 staff to participant ratio during the collection of VAS scales
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.