The purpose of this study is to assess the abuse potential of single doses of pitolisant relative to phentermine HCl and placebo, when administered to healthy, non-dependent, recreational stimulant users.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
Pitolisant 40 mg or 240 mg (tablets over-capsuled)
tablets over-capsuled
Phentermine 60 mg (capsule over-capsuled)
INC Research
Toronto, Ontario, Canada
Maximum effect (Emax) on Drug Liking visual analog scale (VAS)
Drug liking VAS is one of the measures of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm).
Time frame: Within 24 hours post-dose
Drug Liking VAS (minimum effect [Emin] and time-averaged area under the effect curve to 24 hours after study drug administration [TA_AUE])
Drug liking VAS is one of the measures of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm).
Time frame: Within 24 hours post-dose
Overall Drug Liking VAS (Emax/Emin)
Overall drug liking VAS is one of the measures of balance of effects that assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm bipolar VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm= "neither like nor dislike", and 100 mm= "strong liking").
Time frame: Within 24 hours post-dose
Take Drug Again VAS (Emax)
Take drug again VAS is one of the measures of balance of effects. It is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm bipolar VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely not", 50 mm = "do not care", and 100 mm = "definitely so").
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Time frame: Within 24 hours post-dose
Good Effects VAS (Emax and TA_AUE)
Good drug effects VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).
Time frame: Within 24 hours post-dose
Bad Effects VAS (Emax and TA_AUE)
Bad effects VAS is one of the measures of negative effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).
Time frame: Within 24 hours post-dose
ARCI-A scale (Emax and TA_AUE)
ARCI-A is measure of other stimulant effects. It is a set of 13 questions in which each question contributes to total score. Participants select 'False' / 'True' for response. One point given for each response that agrees with scoring direction, true items receive score of 1 if answer 'True', false items receive score of 1 if answer 'False'. No points if answer is opposite to scoring direction. Score range: 0 to 13, higher score indicated higher other subjective effects.
Time frame: Within 24 hours post-dose
ARCI-BG scale (Emax and TA_AUE)
ARCI-BG is measure of other subjective effects. It is a set of 13 questions in which each question contributes to total score. Participants select 'False' / 'True' for response. One point given for each response that agrees with scoring direction, true items receive score of 1 if answer 'True', false items receive score of 1 if answer 'False'. No points if answer is opposite to scoring direction. Score range: 0 to 13, higher score indicated higher other subjective effects.
Time frame: Within 24 hours post-dose
Agitation/Relaxation VAS (Emax and TA_AUE)
Agitation/Relaxation VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Time frame: Within 24 hours post-dose
Drug Similarity VAS (score at 24 hours after study drug administration)
Drug similarity VAS is one of the measures of other subjective effects. It assesses the similarity of the drug recently received by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= not at all similar) to 'extremely' (score of 100 mm= very similar).
Time frame: Within 24 hours post-dose
Safety and tolerability of Pitolisan HCl as assessed by AEs
AEs assessment
Time frame: Up to 6 weeks
Safety and tolerability of Pitolisan HCl by laboratory assessments
Laboratory assessments
Time frame: Up to 6 weeks
Safety and tolerability of Pitolisan HCl as assessed by 12-lead ECGs
12-lead ECGs assessments
Time frame: Up to 6 weeks
Safety and tolerability of Pitolisan HCl as assessed by vital signs
Vital signs assessment
Time frame: Up to 6 weeks
Safety and tolerability of Pitolisan HCl as assessed by physical examination
Physical examination assessment
Time frame: Up to 6 weeks