HUMAN ABUSE POTENTIAL STUDIES
Human Abuse Potential (HAP) Studies: Trusted Expertise to Support Drug Scheduling
Human Abuse Potential (HAP), also referred to as Human Abuse Liability (HAL) studies, are a critical component of the evidence package submitted with a New Drug Application (NDA) to determine a product’s Controlled Substances Act (CSA) scheduling. HAP studies are not just a regulatory requirement; they provide critical insight into the abuse liability of new chemical entities (NCEs) and formulations. Combined with preclinical data and pharmacological profiles, chemistry and clinical data, HAP findings directly inform scheduling decisions and support safer product development.
Why Choose Altasciences for HAP and HAL Studies?
- Industry-Leading Experience
- Trusted by Regulatory Authorities
We’ve completed 100+ HAP, substance abuse, and abuse-deterrent formulation (ADF) studies, making us a proven leader in the field.
Altasciences holds multi-year research contracts with the FDA and NIH, a strong testament to our scientific credibility and regulatory alignment.
- Regulatory-Ready Data
- Integrated Drug Development Services
Our specialized teams know exactly what regulators expect to ensure your data package meets the highest standards for drug approval and scheduling.
From preclinical studies to clinical trial conduct and regulatory strategy, we offer seamless support throughout your product’s development lifecycle.
Consult our Human Abuse Potential Study Fact Sheet
PLANNING A HAP TRIAL?
PARTNER WITH THE EXPERTS.
Does your investigational drug need to be evaluated for abuse potential or dependency? Would your CNS-active drug benefit from an ADF that could extend its patent exclusivity? You can trust us with your evaluations, the most experienced and knowledgeable CRO for HAP studies in North America.
Our globally recognized team guides pharmaceutical companies through every stage of abuse potential evaluations. Our experts actively lead and contribute to key industry groups, including the Cross-Company Abuse Liability Council (CCALC) and working groups within the International Society of CNS Clinical Trials and Methodology (ISCTM). Our team provides strategic regulatory guidance, assesses the need for studies or the possibility of waivers, and offers end-to-end support in the design, conduct, and analysis of HAP and HAL studies. Uniquely positioned as the only CRO with a fully integrated, multidisciplinary team, we deliver comprehensive capabilities to determine whether your compound may require scheduling under the Controlled Substances Act—including conducting the 8-Factor Analyses.
WHERE SCIENTIFIC INNOVATION MEETS REGULATORY INSIGHT
As the CNS therapeutic landscape evolves with increased interest in novel agents such as psychedelic analogs, we are pioneering methodological innovations to help sponsors address emerging regulatory and scientific challenges. Our active leadership in industry discussions and continuous collaboration with regulators ensures your program is guided by the latest best practices and up-to-date regulatory expectations.
SPECIALIZED FACILITIES AND EXPERTISE FOR HAP STUDIES
Our adaptive clinical pharmacology unit in Kansas City is purpose-built for studies requiring a high level of environmental control and specialty populations. This 30-bed, secured, limited-access unit provides the ideal setting for conducting complex early-phase trials, especially in areas such as Human Abuse Potential (HAP), and Abuse-Deterrent Formulation (ADF) studies.
Purpose-Built for High-Control Clinical Research
- 30-bed secured, limited-access facility
- Self-contained and adaptive unit
- Ideal for CNS, HAP, and ADF trials
Ensures full control over environmental variables, reducing external influences and protecting data quality.
Designed to accommodate complex pharmacology studies with sensitive or high-risk populations.
Environmentally controlled setting supports rigorous safety protocols and accurate assessments.
Accurate and Consistent Pharmacodynamic (PD) Data Collection
We ensure high-quality, validated PD data through electronic collection and highly trained teams:
- Electronic data capture for accuracy, consistency, and compliance
- Qualified raters with study-specific training before each trial
- 1:1 staff-to-participant ratio during PD assessments to enhance:
- Data integrity
- Participant comprehension
- Safety monitoring
- Clear participant instructions to reduce variability and support compliance
Consistent Quality Across All Altasciences Sites
Beyond Kansas City, all Altasciences clinical sites across North America offer:
- Secure, flexible environments for high-control studies
- Staff trained in CNS pharmacology and abuse liability protocols
- Experience in CNS, HAP, and ADF clinical trials
- End-to-end drug development support, from study design to data delivery
RAPID STUDY START-UPS FOR HAP CLINICAL TRIALS
We understand the urgency of the early-phase development of your drug. HAP trials can be initiated in as little as four weeks, leveraging:
- a dual project management structure to align sponsor and internal timelines
- streamlined contracts and regulatory document preparation
- efficient participant recruitment, even for specialized populations
Our integrated model includes three clinical pharmacology units and co-located bioanalytical labs in the U.S. and Canada, offering multiple regulatory pathways for flexibility and speed.
CASE STUDY―Streamlining Clinical Trial Start-up for Accelerated Drug Development
TARGETED RECRUITMENT FOR HAP STUDIES
We maintain a robust database of recreational dependent drug users across a range of substances, including:
- opioids
- stimulants
- sedative-hypnotics
- cannabinoids
With this diverse participant pool, we deliver studies with scientific rigor, operational efficiency, and high-quality outcomes. Our upscale facilities and experienced recruitment team ensure rapid enrollment and industry-leading retention—with up to 90 days of consecutive confinement when required.
As the longest continuously operating CRO specializing in human abuse potential studies, we offer unparalleled access to a diverse and well-characterized participant population.
Key Advantages of Our Recruitment Strategy
- Dedicated internal recruitment team
- Targeted outreach from a well-maintained participant database
- Predictable, accelerated enrollment timelines
- High retention rates for long-duration studies
TURNKEY SOLUTIONS FOR YOUR HUMAN ABUSE POTENTIAL TRIALS
Altasciences offers fully integrated services, streamlining the entire clinical process for HAP and ADF studies:
Protocol Review/Writing:
From de novo to protocol refinement, our experts ensure your protocol meets FDA, HC, and/or EMA expectations.
Bioanalytical Services:
Co-located labs are equipped with a wide range of methods and assays, ensuring precise and timely PK data, biomarkers of inflammation, and others as appropriate.
PK/PD Expertise:
Robust PK/PD analyses are supported by expert statisticians and trained facilitators with extensive HAP protocol experience.
Specialized CNS Capabilities:
Our clinic staff is highly trained in conducting CNS drug trials, ensuring exceptional participant safety, protocol fidelity, and data integrity.
Regulatory and Scientific Support:
In-house regulatory specialists and scientists provide comprehensive guidance, including 8-Factor Analyses, FDA-recommended hypothesis testing, and rigorous data validation.
World-Class Team:
Our multidisciplinary team includes a seasoned Principal Investigator, a psychiatrist with over 25 years of experience, a clinical neuropsychologist specializing in pharmacodynamic assessments, and internationally recognized scientists in abuse potential evaluation.
When you partner with us, your abuse potential studies are in expert hands—from protocol development to final report.
CASE STUDIES AND SCIENTIFIC RESOURCES
SCIENTIFIC POSTERS
FAQs
What is a Human Abuse Potential Study?
Human abuse potential (HAP) studies are essential for evaluating whether a drug is likely to be misused for non-medical, recreational purposes once marketed. These studies play a central role in informing drug scheduling decisions under the Controlled Substances Act and are conducted in accordance with detailed regulatory expectations outlined in the FDA guidance.
Typically designed as single-dose, double-blind, randomized crossover trials, HAP studies compare an investigational drug to both placebo and one or more active controls— scheduled substances with established abuse potential.
Why are Human Abuse Potential Studies Important?
Evaluating the abuse and dependence potential of CNS-active drugs is a critical element in assessing their overall safety and understanding the risks of misuse, dependence, and withdrawal. Regulatory agencies such as the FDA mandate rigorous, well-defined testing for many CNS-active compounds, including human abuse potential (HAP) studies that must adhere to specific guidance documents and scientific standards.
Our team is at the forefront of evolving adaptations to accommodate unique pharmacological profiles. We work in close collaboration with regulatory agencies and stakeholders to ensure studies meet current expectations and support efficient NDA submissions.