A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem
- 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.
- Short title
- A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-05-12
- First posted
- 2021-11-03
- Registry last updated
- 2025-04-27
- Primary completion date
- 2023-05-12
- Start date
- 2021-12-17
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Janssen Research & Development, LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05106153
- ClinicalTrials.gov ID
- NCT05106153
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Crossover
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS)
Timeframe: Up to 24 hour post-dose (up to Day 2)
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).
Overall Drug Liking VAS (Emax)
Timeframe: 12 hour and 24 hour post-dose
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).
Take Drug Again VAS (Emax)
Timeframe: 12 hour and 24 hour post-dose
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).
Subjective Drug Value (Emax)
Timeframe: 12 hour and 24 hour post-dose
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.
High VAS (Emax)
Timeframe: Pre-dose up to 24 hours post-dose (up to Day 2)
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).
Time to Peak Effect (TEmax) for Drug Liking (At this Moment) VAS
Timeframe: Up to 24 hour post-dose (up to Day 2)
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).
Minimum Effect (Emin) for Drug Liking (At this Moment) VAS
Timeframe: Up to 24 hour post-dose (up to Day 2)
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).
Time to Minimum Effect (TEmin) for Drug Liking (At this Moment) VAS
Timeframe: Up to 24 hour post-dose (up to Day 2)
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).
Time-averaged Area Under the Effects Curve (TA_AUE) for Drug Liking (At This Moment) VAS
Timeframe: Up to 24 hour post-dose (up to Day 2)
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).
TEmax of High VAS
Timeframe: Pre-dose up to 24 hours post-dose (up to Day 2)
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).
TA_AUE of High VAS
Timeframe: Pre-dose up to 24 hours post-dose (up to Day 2)
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).
Emax of Good Effect VAS
Timeframe: Up to 24 hour post-dose (up to Day 2)
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).
TEmax of Good Effects VAS
Timeframe: Up to 24 hour post-dose (up to Day 2)
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).
TA_AUE of Good Effects VAS
Timeframe: Up to 24 hour post-dose (up to Day 2)
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).
Emax of Bad Effects VAS
Timeframe: Up to 24 hour post-dose (up to Day 2)
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').
TA_AUE of Bad Effects VAS
Timeframe: Up to 24 hour post-dose (up to Day 2)
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').
TEmax of Bad Effects VAS
Timeframe: Up to 24 hour post-dose (up to Day 2)
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').
Emin of Drowsiness/Alertness VAS
Timeframe: Pre-dose up to 24 hours post-dose (up to Day 2)
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).
TEmin of Drowsiness/Alertness VAS
Timeframe: Pre-dose up to 24 hours post-dose (up to Day 2)
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).
Time-averaged Area Over the Effect Time Curve (TA_AOE) of Drowsiness/Alertness VAS
Timeframe: Pre-dose up to 24 hours post-dose (up to Day 2)
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).
Emin of Relaxation/Agitation VAS
Timeframe: Pre-dose up to 24 hours post-dose (up to Day 2)
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).
TEmin of Relaxation/Agitation VAS
Timeframe: Pre-dose up to 24 hours post-dose (up to Day 2)
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).
TA_AOE of Relaxation/Agitation VAS
Timeframe: Pre-dose up to 24 hours post-dose (up to Day 2)
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).
TEmax of Dizziness VAS
Timeframe: Pre-dose up to 24 hour post-dose (up to Day 2)
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).
Emax of Dizziness VAS
Timeframe: Pre-dose up to 24 hour post-dose (up to Day 2)
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).
TA_AUE of Dizziness VAS
Timeframe: Pre-dose up to 24 hour post-dose (up to Day 2)
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).
And 10 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- Yes
- 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
- 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
- Altasciences Inc.Overland Park, United States
Other registry identifiers
- 42847922MDD1017