Human Abuse Liability & Abuse Potential


    Human Abuse Liability (HAL) or Human Abuse Potential (HAP) clinical studies may be required by the FDA to evaluate the abuse liability or abuse potential of a New Chemical Entity (NCE) for drugs that affect the central nervous system. HAL studies provide insight to understand if the drug is “liked” as compared to a drug in the same drug class or a drug that has the same or similar mechanism.

    In other instances, sponsors are required to evaluate the effectiveness of an Abuse Deterrent Formulation (ADF). For ADF trials, the objective is to assess the ability of the new formulation to be tampered with and abused, and is often pursuant to a 505(b)(2) strategy. The complicated regulatory pathway for HAL protocol design (comparator, recruiting, etc.) requires individualized consulting for each case.

  • HAL/HAP Experience

    Principal Investigators have over 40 years combined substance abuse clinical experience

    • Industry leader in the conduct of substance abuse clinical trials
    • Conducted 35 HAL/HAP trials in the past 3 years in addition to a variety of substance abuse studies
    • Access to large database of recreational drug users for rapid study enrollment and start-up
    • Experience in a diverse range of HAL/HAP studies including opioids (oral and nasal snorting), methadone/buprenorphine, hydromorphone challenge, alcohol interaction, hypnotics and stimulants
    • Full-time clinical research pharmacists
    • USP 797 certified clean room with Class II Biological Safety Cabinet
    • Negative Pressure, HEPA-filtered extemporaneous compounding room equipped with PowderSafe Ductless Balance Enclosure
    • Extemporaneous and intravenous preparation, including both large and small molecules
    • DEA Schedule I license to conduct research with Tetrahydrocannabinols (THC)

    Vince & Associates’ physicians are experienced in working with both substance dependent volunteers and recreational drug users.

    We have expertise in the identification of appropriate study subjects for substance abuse studies including nasal snorting, methadone/buprenorphine, hydromorphone challenge, alcohol interaction

Pharmacy Expertise

Our pharmacists have extensive knowledge and experience in preparing and dosing Human Abuse Liability and substance abuse studies via oral, sublingual, intranasal and parenteral routes.

Additionally, our pharmacy capabilities include over-encapsulation, manipulation and usability processing of Abuse Deterrent oral dosage forms and the blinding of referenced and comparator products. Our specialized pharmacy services include a multitude of formulation preparations and administration routes.

Both clinical research pharmacists have been trained at the Professional Compounding Centers of America and have specialized abuse deterrent preparation and manipulation training.

Electronic Visual Analog Scales (VAS)

Vince & Associates staff are highly trained and experienced in the use of electronic Visual Analog Scales. Using computerized assessments provides automated outcome measures. The touchscreen tablet PC or iPad format has rapid set up, and the proprietary software is 21 Part 11 compliant.

Adaptive Clinical Pharmacology Unit (CPU)

Vince & Associates has designed and built an adaptive CPU to provide a highly reconfigurable and adaptable space for our biopharmaceutical clients to use for their complex clinical trials with challenging subject populations. This new space is a (30-bed) locked, limited-access, self-contained unit incorporated into the overall footprint of the (140-bed) general population research campus – the perfect size and scale to conduct a single clinical trial, especially when managing critical endpoints, monitoring adverse events or performing complex medical procedures. It allows our Phase 1 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.

Bioanalytical Assays Developed

  • Amphetamine Mixed Salts
  • Buprenorphine / Norbuprenorphine
  • Codeine (and metabolites)
  • Hydrocodone
  • Hydromorphone
  • Lorazepam
  • Methylphenidate (chiral method also available)
  • Morphine Noroxycodone
  • M6G
  • Oxycodone / Noroxycodone / Oxymorphone
  • Zolpidem
  • Cocaine (in development)
  • Additional assays can be developed and tailored to your program upon request

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