Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 26
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37Contains Nonbinding Recommendations
C. Human Abuse Potential Study in Recreational Drug Users
The primary objective of a HAP study is to provide information on the relative abuse potential of
a test drug (generally an NME) in humans. Data from HAP studies are important in developing
abuse-related drug product labeling and in determining whether the drug product will be
scheduled under the CSA. As noted above in Section III.A, a HAP study will likely be necessary
when abuse-related signals occur in nonclinical studies or if abuse-related AEs are observed in
clinical studies. HAP studies that are designed to specifically test the effectiveness of a new
opioid formulation in providing meaningful abuse deterrence, are described in the guidance for
industry, Abuse-Deterrent Opioids – Evaluation and Labeling (2015).
During drug development, it is generally advised that HAP studies not be conducted prior to the
end of phase 2 clinical studies. This should ensure that the doses used in the HAP study are
based on the final proposed therapeutic doses and have established safety following phase 1
studies in healthy individuals and phase 2 studies in individuals with the disease of interest.
Typically, HAP studies evaluate the highest proposed therapeutic dose of the test drug as well as
doses that are multiples of the highest proposed therapeutic dose (usually 2-3 times greater, if
this can be done safely) in comparison to a positive control(s) and placebo.
1.
Study Site
HAP studies are typically conducted in an inpatient or outpatient human pharmacology
laboratory setting. In the outpatient setting, subjects should be screened for drugs of abuse when
returning to the laboratory unit prior to the administration of a study treatment. Given that
supratherapeutic doses are tested in these studies, medical personnel and equipment should be
available to adequately respond to AEs that could compromise the safety of the subjects enrolled
in the study. Safety measures should be in place to ensure that subjects are not released from the
laboratory unit until they are no longer impaired by drugs administered during the study.
2.
Subjects and Sample Size
HAP studies should be conducted in experienced recreational drug users who have a recent
history of using drugs in the same general pharmacological class as the test drug (e.g., sedative,
stimulant, opioid, or hallucinogen). Typically, subjects who qualify for the study have had
numerous recent recreational experiences with the drug class. This drug history ensures that
subjects are so familiar with the psychoactive effects of the drug class that they can both identify
and tolerate the drug class. Ideally, subjects should prefer this drug class for recreational use. It
is not recommended that drug-naïve subjects be used in HAP studies because this population has
not been validated scientifically as being able to provide accurate information on the abuse
potential of a drug.
During screening, a thorough recreational drug history should be taken from each potential
subject that details the drugs used, the frequency of use (overall number of times used and
typical amount used), and the time since last use. Individuals should be excluded from
participation in the study if they are currently dependent on a drug (other than caffeine or
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