A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem

Abuse Potential Clinical Trial

Official title:

A Single-Dose, Double-Blind, Placebo-Controlled, Randomized, Crossover Study to Determine the Abuse Potential of Single Oral Dose of Seltorexant Compared To Suvorexant and Zolpidem

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106153
• Other study ID #: CR109099
• Secondary ID: 42847922MDD1017
• Status: Completed
• Phase: Phase 1
• Start date: December 17, 2021
• Est. completion date: May 12, 2023

Study information

• Verified date: July 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the abuse potential of seltorexant compared to placebo and two active comparators (zolpidem and suvorexant) in non-dependent, recreational sedative users.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Be a current, recreational, not physically dependent, drug user
• Participant must be medically stable
• All female participants must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of the qualification phase and on Day -1 of each treatment period of the treatment Phase
• Blood pressure (after the participant is in a sitting position for 5 minutes) between 90 millimeters of mercury (mmHg) and 160 mmHg systolic, inclusive, and no higher than 100 mmHg diastolic at screening and Day -1 prior to qualification phase randomization
• A 12-lead ECG consistent with normal cardiac conduction and function, including: sinus rhythm, pulse rate between 40 and 100 beats per minute (bpm), QTc interval less than or equal to (<=) 450 milliseconds (ms) for males, <=470 for females, QRS interval of less than (<) 120 ms, PR interval <210 ms, Morphology consistent with healthy cardiac conduction and function

Exclusion Criteria:

• Known allergies to seltorexant, zolpidem, and suvorexant
• Previous history of recurrent fainting, collapses, syncope, orthostatic hypotension, or vasovagal reactions
• Prescription medications except for stable medical problems such as hypertension, elevated cholesterol, and non-insulin-dependent diabetes mellitus with stable medications for at least 1 month prior to screening
• Participants who have ever been in treatment for substance use disorders (except smoking cessation) or are currently seeking treatment for substance use disorders. In addition, currently seeking or participating in a substance rehabilitation program should be excluded
• Preplanned surgery or procedures that would interfere with the conduct of the study

Related Conditions & MeSH terms

• Abuse Potential

Intervention

Drug:
• Suvorexant
Suvorexant will be administered orally as per assigned treatment sequence.
• Zolpidem
Zolpidem will be administered orally as per assigned treatment sequence.
• Seltorexant
Seltorexant will be administered orally as per assigned treatment sequence.
• Placebo
Placebo will be administered orally as per assigned treatment sequence.

Locations

Country	Name	City	State
United States	Altasciences Inc.	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS)	Emax for drug liking VAS will be reported. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).	Up to 24 hour post-dose (up to Day 2)
Secondary	Overall Drug Liking VAS (Emax)	Emax for overall drug liking VAS will be reported. Peak effect for overall drug liking based on bipolar VAS from 0 (strong disliking) to 100 (strong liking).	12 hour and 24 hour post-dose
Secondary	Take Drug Again VAS (Emax)	Emax for take drug again VAS will be reported. Peak effect for take drug again based on bipolar VAS from 0 (definitely no) to 100 (definitely so).	12 hour and 24 hour post-dose
Secondary	Subjective Drug Value (Emax)	Subjective drug value will be reported. The subjective drug value is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between drug administered and different monetary values.	12 hour and 24 hour post-dose
Secondary	High VAS (Emax)	High VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 millimeter (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 = definitely so).	Pre-dose up to 24 hours post-dose (up to Day 2)
Secondary	Time to Peak Effect (TEmax) for Drug Liking (At this Moment) VAS	TEmax is defined as time to peak effect for drug liking (at this moment). Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).	Up to 24 hour post-dose (up to Day 2)
Secondary	Minimum Effect (Emin) for Drug Liking (At this Moment) VAS	Emin is defined as minimum effect for drug liking (at this moment). Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).	Up to 24 hour post-dose (up to Day 2)
Secondary	Time to Minimum Effect (TEmin) for Drug Liking (At this Moment) VAS	TEmin is defined as time to minimum effect for drug liking (at this moment). Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).	Up to 24 hour post-dose (up to Day 2)
Secondary	Time-averaged Area Under the Effects Curve (TA_AUE) for Drug Liking (At This Moment) VAS	TA_AUE is defined as time-averaged area under the effects curve for drug liking (at this moment). Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).	Up to 24 hour post-dose (up to Day 2)
Secondary	TEmax of High VAS	TEmax of high VAS will be reported. High 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 = definitely so).	Pre-dose up to 24 hours post-dose (up to Day 2)
Secondary	TA_AUE of High VAS	TA_AUE of high VAS will be reported. High 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 = definitely so).	Pre-dose up to 24 hours post-dose (up to Day 2)
Secondary	Emax of Good Effect VAS	Emax of good effect VAS will be reported. 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).	Up to 24 hour post-dose (up to Day 2)
Secondary	TEmax of Good Effects VAS	TEmax of good effects VAS will be reported. 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).	Up to 24 hour post-dose (up to Day 2)
Secondary	TA_AUE of Good Effects VAS	TA_AUE of good effects VAS will be reported. 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).	Up to 24 hour post-dose (up to Day 2)
Secondary	Emax of Bad Effects VAS	Emax of bad effects VAS will be reported. Bad effects VAS measures the negative effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').	Up to 24 hour post-dose (up to Day 2)
Secondary	TA_AUE of Bad Effects VAS	TA_AUE for bad effects VAS will be reported. Bad effects VAS measures the negative effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').	Up to 24 hour post-dose (up to Day 2)
Secondary	TEmax of Bad Effects VAS	TEmax of bad effects VAS will be reported. Bad effects VAS measures the negative effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').	Up to 24 hour post-dose (up to Day 2)
Secondary	Emin of Drowsiness/Alertness VAS	Emin of Drowsiness/Alertness VAS will be reported. Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm).	Pre-dose up to 24 hours post-dose (up to Day 2)
Secondary	TEmin of Drowsiness/Alertness VAS	TEmin of Drowsiness/Alertness VAS will be reported. Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm).	Pre-dose up to 24 hours post-dose (up to Day 2)
Secondary	Time-averaged Area Over the Effect Time Curve (TA_AOE) of Drowsiness/Alertness VAS	TA_AOE is defined as time-averaged area over the effect time curve. Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm).	Pre-dose up to 24 hours post-dose (up to Day 2)
Secondary	Emin of Relaxation/Agitation VAS	Emin of relaxation/agitation VAS will be reported. 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).	Pre-dose up to 24 hours post-dose (up to Day 2)
Secondary	TEmin of Relaxation/Agitation VAS	TEmin of relaxation/agitation VAS will be reported. 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).	Pre-dose up to 24 hours post-dose (up to Day 2)
Secondary	TA_AOE of Relaxation/Agitation VAS	TA_AOE of relaxation/agitation VAS will be reported. 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).	Pre-dose up to 24 hours post-dose (up to Day 2)
Secondary	TEmax of Dizziness VAS	TEmax of dizziness VAS will be reported. Dizziness VAS assesses the effect of dizziness 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).	Pre-dose up to 24 hour post-dose (up to Day 2)
Secondary	Emax of Dizziness VAS	Emax of dizziness VAS will be reported. Dizziness VAS assesses the effect of dizziness 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).	Pre-dose up to 24 hour post-dose (up to Day 2)
Secondary	TA_AUE of Dizziness VAS	TA_AUE of dizziness VAS will be reported. Dizziness VAS assesses the effect of dizziness 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).	Pre-dose up to 24 hour post-dose (up to Day 2)
Secondary	Emax of Any Effects VAS	Emax of any effects VAS will be reported. Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').	Up to 24 hour post-dose (up to Day 2)
Secondary	TEmax of Any Effects VAS	TEmax of any effects VAS will be reported. Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').	Up to 24 hour post-dose (up to Day 2)
Secondary	TA_AUE of Any Effects VAS	TA_AUE of any effects VAS will be reported. Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').	Up to 24 hour post-dose (up to Day 2)
Secondary	Drug Similarity VAS	Drug similarity VAS will be reported. The Drug Similarity unipolar VAS items provide an estimate of the drug class with which drug users identify the test drug. It is a unipolar scale ranging from 0 (not at all similar) to 100 points ( very similar).	24 hour post-dose
Secondary	Percentage of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.	Up to Week 20
Secondary	Percentage of Participants with Serious Adverse Events (SAEs)	An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.	Up to Week 20
Secondary	Percentage of Participants with Abnormalities in Clinical Laboratory Parameters	Percentage of participants with abnormalities in clinical laboratory parameters (included hematology, clinical chemistry, and routine urinalysis) will be reported.	Up to 24 hour post-dose (up to Day 2)
Secondary	Percentage of Participants with Abnormalities in Vital Signs	Percentage of participants with abnormalities in vital signs (included temperature, pulse/heart rate, blood pressure [diastolic and systolic]) will be reported.	Up to 24 hour post-dose (up to Day 2)
Secondary	Emin of Modified Observer's Assessment of Alertness/Sedation (MOAA/S) of Composite and Sum Score	Emin of MOAA/S of composite and sum score will be reported. The MOAA/S is an observer-rated measure of alertness/sedation that is used widely in clinical research. The MOAA/S scores range from 5 (not sedated) to 0 (unarousable). The observer's assessment of alertness/sedation scale (OAA/S) was developed to measure the level of alertness in participants who are sedated. The OAA/S is a reliable validated measure and was shown to be sensitive to different levels of sedation and is composed of 4 assessment categories that include responsiveness, speech, facial expression, and eyes. The MOAA/S includes only the Responsiveness assessment category.	Up to 24 hour post-dose (up to Day 2)
Secondary	TA_AOE of MOAA/S of composite and sum score	TA_AOE of MOAA/S of composite and sum score will be reported. The MOAA/S is an observer-rated measure of alertness/sedation that is used widely in clinical research. The MOAA/S scores range from 5 (not sedated) to 0 (unarousable). The observer's assessment of alertness/sedation scale (OAA/S) was developed to measure the level of alertness in participants who are sedated. The OAA/S is a reliable validated measure and was shown to be sensitive to different levels of sedation and is composed of 4 assessment categories that include responsiveness, speech, facial expression, and eyes. The MOAA/S includes only the Responsiveness assessment category.	Up to 24 hour post-dose (up to Day 2)