The Importance of Clinical Trials

Well-designed clinical trials pave the way for knowledge and access to new treatments and procedures that can benefit millions around the world. Part of the wide scope of clinical research are human abuse liability studies that I was fortunate to learn and conduct in my career with BioPharma Services.

Understanding Human Abuse Liability (HAL) Studies

At its core, Human Abuse Liability (HAL) studies are designed to evaluate the potential abuse of medications, especially those that affect the central nervous system (CNS). These studies are a critical component in the drug development process, ensuring that new medications, though beneficial, do not inadvertently contribute to the growing issue of drug misuse and addiction.

Human abuse liability, or HAL studies, are one of the most important types of clinical research to perform if you are manufacturing a new drug product with abuse potential or possibility of misuse of drugs with central nervous system (CNS).

The Global Challenge of Opioid Misuse

Opioid use disorder, defined as the chronic use of opioids leading to clinically significant distress or impairment, is a pressing global issue. With over 16 million people affected worldwide, the United States stands out, with more than 2.1 million people grappling with this disorder. The alarming figures from the CDC last year indicated a daunting 120,000 deaths globally due to opioid-related overdoses. It’s worth noting that a significant portion of this misuse originates from legitimate prescriptions, with many recreational users admitting to sourcing opioids from friends and family.

The Role and Significance of HAL Studies

Human abuse liability studies are critical in obtaining a thorough assessment of the rate of the drug absorbed in the system through different routes, in addition to assessing the behaviour changes on subjects. Using tools that bypass the individual bias on a subject, gives us a better understanding, while also serving as a guide for the FDA and also other global health governing bodies. There is also an importance of a humanity level to this sense as almost everybody may have or had experience with overuse, abuse or addiction.

Regulatory Importance of HAL Studies

Human Abuse Liability studies are not just a best practice in the Canada or the U.S; they are a regulatory requirement for drugs with potential abuse. As a Canadian CRO, we strictly follow the guidance on the Clinical Assessment of Abuse Liability for drugs with central nervous system activity. The FDA heavily scrutinizes these studies during the drug approval process. A drug’s abuse potential can significantly influence its scheduling under the Controlled Substances Act, which can, in turn, affect its market potential and prescribing guidelines.

This blog will provide a rundown of my experience in conducting human abuse liability studies within a CRO like BioPharma Services from the protocol review, submissions through evaluation and assessment.

The Human Abuse Liability Study experience at BioPharma

BioPharma Services has completed multiple Human Abuse potential studies within the 17+ years of service.

These studies are some of the most elaborated human abuse liability studies because not only do they have a subjective component like PKA, vitals, ECG, pupillometry, but they also are trying to look more on the subjective side through elaborated questionnaires, etc. These elaborate designs apply from the first step screening by applying standardized scales from known sources like DSM which is important in the fact that it increases the reliability of the study and selection/conformation period and also during the study itself after the confirmation period of the study participants.

BioPharma Services provides support to its sponsors by helping with building the study protocol. This includes providing review from experienced clinical pharmacology scientists detailing study design based on experience, as well as confirming compliance with the latest regulatory rules and regulations with the regulatory affairs team.

Dr. Isabella Szeto, one of our experienced Investigators in Toronto, whom I was honoured to work with during the conduct of the human abuse liability studies, has provided the team multiple training sessions that are both non-protocol specific and protocol specific. This included 1:1 training with the safety team and CRC team to prepare for many first human abuse liability studies.

BioPharma Services has built a database system that includes recreational users, and was able to succeed in its marketing, utilizing a referral program and community engagement plan to screen and dose new volunteers for this human abuse liability study.

As similar studies require long confinements, we utilized private/semi private patients rooms to conduct this study, individual recliners to seek the subject’s comfort and individual bathrooms with showers.

Multiple approved vendors were utilized to bring similar meals during confinement and many entertainment options that varied from books, video games, to many other forms of entertainment. BioPharma Services has a controlled susbtance registered pharmacy and a licensed pharmacist to store and administer controlled substances. Each room had 24 hour temperature and humidity monitoring and In-house drug compounding and reconstitution capabilities.

The Importance of Subject Selection and Training

In this human abuse liability study, our team has worked with experienced investigators who are able to identify appropriate subjects for substance abuse studies using protocol specific inclusion/ exclusion criteria and the Diagnostic and Statistical Manual of Mental Disorders (DSM). Screened subjects continue to a qualification phase, where “initial passed” subjects go through a Positive Control and Placebo administration. This allows us to identify subjects who can tolerate Positive Control. The subjects are selected through a rigorous process with outermost care and importance of safety and also creating a nonjudgmental environment that is conducive to the highest level of cooperation from the subject by offering layers of privacy and support that translate to a high rate of adherence to the study protocol.

A major part of the human abuse liability studies is the Cambridge Cognition for VAS scale collection; this is a computerized scale of assessments for pharmacodynamic measures such as drug liking. Cambridge Cognition is remotely deployed in 100+ countries and used in FDA and EMA clinical trials. Our experienced Pharmacology scientists perform training on the use of the tablet-based software for staff and subjects providing IRB approved training slides, so subjects of the human abuse liability study can understand the expectations and the differences between neutral points on 3-anchor vs. 2- anchor scales, In-the-moment vs. overall scales. All results are sent to our scientific team to perform Pharmacodynamic Assessments (PD) and will confirm Subject’s eligibility to be randomized for the study conduct.

The Treatment Phase in HAL Studies

Test your compound for abuse liability potential. All subjects who passed PD measures and safety evaluations are randomized in the treatment phase. This phase includes dosing each subject with multiple doses of the test drug with the highest proposed therapeutic dose in humans as well as a dose 2–3 times that dose as long as there are no safety concerns, Placebo and one or two doses of positive control so each subject act as their own control. This phase of a human abuse liability study is not only important for obtaining Pharmacodynamic measures but also to confirm safety, Pharmacokinetic data and assessment for new adverse events.

The BioPharma Services experience with these studies has been extensive, and we are confident that we can provide our expertise not only by already a large database of identifiable subjects that cross race and gender but also flexibility of the team to meet the sponsor’s unique needs. Our availability of the PI/sub-investigator team is 24/7 to discuss any concerns for your next drug development project. The BioPharma Services team is already employing some of the most sophisticated tools, programs not only to meet the standard of these studies but, also to make us extremely competitive in drug development.

Why Choose BioPharma Services for your next drug development project?

Experience & Expertise: 

BioPharma Services has successfully completed over 100 studies, a testament to the company’s proficiency and know-how in this specialized domain. But numbers alone don’t tell the full story. It’s the quality, thoroughness, and rigorous standards maintained in each study that truly sets BioPharma apart.

Innovative Recruitment Strategies: 

Finding the right subjects for human abuse liability studies is a challenge in itself. BioPharma’s unique database system, which includes recreational users, not only streamlines the recruitment process but ensures the right candidates are chosen. Coupled with their successful advertising campaigns and community engagement initiatives, BioPharma ensures that the study’s findings are both robust and reliable.

 Collaborative Protocol Development: 

BioPharma understands that one size does not fit all. They work closely with sponsors to develop tailored study protocols. Their seasoned clinical pharmacology scientists offer insights and recommendations to refine study designs, ensuring they are both compliant with the latest regulatory standards and optimized for the most accurate results.

Training and Capacity Building: 

Training is integral to the success of any human clinical trial. BioPharma’s dedication to training is evident in their collaborations with experts like Dr. Isabella Szeto. Their 1:1 training sessions for safety and CRC teams ensure that every member understands their role, leading to smoother study execution.

State-of-the-Art Facilities: 

It’s not just about conducting the human abuse liability study; it’s about doing it right. BioPharma’s Toronto, Canada research facility is equipped with private/semi-private patient rooms, individual recliners, and personal bathrooms, create a comfortable environment for subjects. This attention to detail reduces external stressors that might affect study outcomes, ensuring more reliable results.

Tech Integration:

BioPharma is at the forefront of integrating technology into their clinical studies. Their collaboration with Cambridge Cognition for VAS scale collection, a tool used in over 100 countries and endorsed by regulatory bodies like the FDA and EMA, showcases their commitment to using the best tools available.

Written by: Israa Diab, Director of Clinical Research

BioPharma Services, Inc., a Think Research Corporation and clinical trial services company, is a full-service Contract Clinical Research Organization (CRO) based in Toronto, Canada, specializing in Phase 1 clinical trials 1/2a and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma conducts clinical research operations from its Canadian facility, with access to healthy volunteers and special populations.

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• Source: https://www.biopharmaservices.com/blog/phase-1-human-abuse-liability-hal-studies-at-biopharma-services/