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.January 2010 Guidance: Assessment of Abuse Potential of Drugs April 2015 Guidance: Abuse Deterrent Opioids – Evaluation and Labeling
Vince & Associates 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 30+ 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 and Human Abuse Liability/Human Abuse Potential.
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.
- 5 year, $5 million contract with the U.S. Food and Drug Administration
- 5 year, $10 million contract with the National Institute on Drug Abuse
Bioanalytical Assays Developed
- Amphetamine Mixed Salts
- Buprenorphine / Norbuprenorphine
- Codeine (and metabolites)
- Methylphenidate (chiral method also available)
- Morphine Noroxycodone
- Oxycodone / Noroxycodone / Oxymorphone
- Cocaine (in development)
- Additional assays can be developed and tailored to your program upon request
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