Human Abuse Potential & Abuse Liability
Innovative and Comprehensive Solutions for Human Abuse Potential Studies
The opioid crisis has had devastating consequences of drug abuse that has become widely recognized. As many as 841,000 people have died from a drug overdose between 1999 and 2019. This increased awareness has led to strict regulatory guidance for the assessment of Human Abuse Potential (HAP Study) of novel drugs.
BioPharma Services, Inc. has extensive expertise in all essential areas necessary for performing Human Abuse Potential studies and Abuse Deterrent Assessment programs. BioPharma Services can also support our clients’ Human Abuse Potential programs competently and efficiently.
Comprehensive Experience with all CNS Compounds
Analgesics | Antidepressants | Anesthetics | Stimulants | Antiparkinsonian Agents
BioPharma’s Accomplished Human Abuse Potential Team
BioPharma’s core Human Abuse Potential team includes experienced abuse potential specialists that were involved in the first-in-human abuse potential studies conducted according to the principles of GCP during the early 2000s, prior to the introduction of the U.S. Food and Drug Administration’s (FDA) Guidance on Abuse Potential and Abuse Deterrent Assessment. Under the expert care and guidance of our Principal Investigator, Dr. Isabella Szeto, we have created innovative and safe study designs, including strategies for the administration of anesthetics and sedatives in healthy volunteers. Learn more about our award winning team.
Medical Director and Principal Investigator with
15 years of research experience in Human Abuse Potential and Abuse Deterrent Assessment.
Dr. Isabella Szeto MD, CCFP, FCFP, CPI – over 15 years of clinical research experience and has conducted and overseen 200+ studies. She has played a key role in the success of multiple Human Abuse Potential programs and is an expert in the creation of innovative and safe study designs
Dr. John Oldenhof, MSc, PhD,
Chief Scientific Officer – over 18 years of experience having overseen 300+ early phase clinical research and Human Abuse Potential and Abuse Deterrent Assessment studies
Project Team – Our talented project team has over 10 years of experience conducting complex Human Abuse Potential studies and building a robust database of recreational drug users.
The Unique Strengths of BioPharma’s Human Abuse Potential Services
Why choose BioPharma Services for your Human Abuse Potential Study? Let us show you The BioPharma Benefits of working with a niche CRO with massive impact.
Clinical Trial Services
State of the art facility. World class leaders. Innovative scientific expertise.
A Large Database of Study Volunteers
From protocol development through to regulatory submission, quality is a given – every step of the way.
Clinical Trial Recruitment
A centrally located state of the art clinical centre in Toronto, Canada that offer extensive safety monitoring.
Visit Us Virtually
Our team has extensive pharmacy compounding capabilities and has been involved in landmark studies on Abuse Deterrent Formulations (ADFs).
Expert Regulatory Support
We competently guide and represent our clients to ensure compliance with all regulatory requirements for Human Abuse Potential studies.
Data Management Services
- Dr. John Oldenhof, MSc, Ph.D., Chief Scientific Officer Dr. Oldenhof has overseen 300+ early phase Human Abuse Potential and Abuse Deterrent Assessment studies. His 18-year tenure in clinical pharmacology has largely been dominated by his work on the design and execution of Human Abuse Potential programs that support the FDA’s mandate for abuse potential assessment of novel chemical entities and abuse deterrence of tamper-resistant technologies. His published work and experience include the development of novel methodologies and study designs, as well as direct collaboration with the US Food and Drug Administration (FDA) to advance Human Abuse Potential studies and pharmacometric analyses.
- Regulatory consultation
- Protocol design and development
- Clinical study execution
- Recreational drug user recruitment
- Clinical Trial Data Management
- Biostatistical analysis and Statistical Analysis Plan (Development)
- Interpretation and report writing
- Ancillary services are also provided through our
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Human Abuse Potential FAQ
What does Human Abuse Potential mean?
Human Abuse Potential (HAP) refers to the type of study that is designed to determine if a new drug has a risk of being diverted and used for recreational purposes instead of its intended clinical indication. There are many medications that are prescribed for a medical indication that have an unintended effect on the brain, causing effects such as euphoria (or “high”). A well-known example are opioids, developed for pain control, and often abused for the unintended high that it some people can experience with its use.
What are methods for Human Abuse Potential studies?
A typical Human Abuse Potential study will compare the investigational drug (study drug) with a placebo (sugar pill) and a positive comparator (a drug already known to have abuse potential and effects similar to the study drug or in the same class of drugs as the study drug). The study will give each subject different doses of the study drug, multiple dosages of the positive comparator and a dose of placebo in separate treatment periods. Subjects will answer questions about how they feel, whether they like the feeling the drug gives them, whether they would take it again, etc. each treatment period, and these answers will be compared to see whether the study drug is “liked” as much as the positive comparator that is known to already be abused. Depending on the answers to these questions, scientists can predict the risk the study drug will be used recreationally, or the abuse potential, of the study drug.
Why is Human Abuse Potential important?
Knowing the Human Abuse Potential of a drug is important for government drug regulatory agencies such as Health Canada and the FDA to monitor and control how drugs can be distributed in order to ensure safety of the drug supply and reduce risk of drug abuse in the population. Drugs that are deemed higher risk of abuse are prescription only, labelled controlled substances, monitored more carefully and have stricter prescribing criteria.
Who does Human Abuse Potential studies?
The study population for HAP studies are subjects who are recreational drug users of the same class or type of drug with similar effects as the investigational/study drug. This population is the most helpful to assess abuse potential, as they are familiar with the comparator drug and like and tolerate the effects. They are typically done in a very controlled clinic setting in a clinical research organization such as BioPharma Services.
What does High Potential for Abuse mean?
A high potential for abuse means that there is a greater risk that a drug will be diverted and used for recreational purposes instead of the intended clinical indication. These drugs with a high potential tend to have greater CNS effects than those with a lower potential for abuse. Drugs that have potential for abuse tend to have central nervous system (CNS) effects. These effects on the brain include euphoria (high), other mood changes, hallucinations, or drugs that have stimulant or depressant effects.