A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem
NCT ID: NCT05106153
Last Updated: 2025-04-27
Study Results
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Basic Information
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COMPLETED
PHASE1
127 participants
INTERVENTIONAL
2021-12-17
2023-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Qualification Phase: Treatment Sequence YXZ
Participants will receive a single oral dose of suvorexant (Treatment Y) in qualification period 1, followed by single oral dose of placebo (Treatment X) in qualification period 2 and then single oral dose of zolpidem (Treatment Z) in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.
Suvorexant
Suvorexant will be administered orally as per assigned treatment sequence.
Zolpidem
Zolpidem will be administered orally as per assigned treatment sequence.
Placebo
Placebo will be administered orally as per assigned treatment sequence.
Qualification Phase: Treatment Sequence ZYX
Participants will receive Treatment Z in qualification period 1, followed by Treatment Y in qualification period 2, and then Treatment X in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.
Suvorexant
Suvorexant will be administered orally as per assigned treatment sequence.
Zolpidem
Zolpidem will be administered orally as per assigned treatment sequence.
Placebo
Placebo will be administered orally as per assigned treatment sequence.
Qualification Phase: Treatment Sequence XZY
Participants will receive Treatment X in qualification period 1, followed by Treatment Z in qualification period 2, and then Treatment Y in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.
Suvorexant
Suvorexant will be administered orally as per assigned treatment sequence.
Zolpidem
Zolpidem will be administered orally as per assigned treatment sequence.
Placebo
Placebo will be administered orally as per assigned treatment sequence.
Qualification Phase: Treatment Sequence YZX
Participants will receive Treatment Y in qualification period 1, followed by Treatment Z in qualification period 2, and then Treatment X in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.
Suvorexant
Suvorexant will be administered orally as per assigned treatment sequence.
Zolpidem
Zolpidem will be administered orally as per assigned treatment sequence.
Placebo
Placebo will be administered orally as per assigned treatment sequence.
Qualification Phase: Treatment Sequence ZXY
Participants will receive Treatment Z in qualification period 1, followed by Treatment X in qualification period 2, and then Treatment Y in qualification period 3 on Day 1 during qualification phase. Each treatment will be separated by washout of at least 3 days.
Suvorexant
Suvorexant will be administered orally as per assigned treatment sequence.
Zolpidem
Zolpidem will be administered orally as per assigned treatment sequence.
Placebo
Placebo will be administered orally as per assigned treatment sequence.
Qualification Phase: Treatment Sequence XYZ
Participants will receive Treatment X in qualification period 1, followed by Treatment Y in qualification period 2, and then Treatment Z in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.
Suvorexant
Suvorexant will be administered orally as per assigned treatment sequence.
Zolpidem
Zolpidem will be administered orally as per assigned treatment sequence.
Placebo
Placebo will be administered orally as per assigned treatment sequence.
Treatment Phase: Treatment Sequence ABFCED
Participants will receive a single oral dose of placebo (Treatment A) in treatment period 1, followed by single oral dose of suvorexant (Treatment B) in treatment period 2, single oral Dose 3 of seltorexant (Treatment F) in treatment period 3, single oral dose of zolpidem (Treatment C) in treatment period 4, single oral Dose 2 of seltorexant (Treatment E) in treatment period 5 and then a single oral Dose 1 of seltorexant (Treatment D) in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.
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.
Treatment Phase: Treatment Sequence BCADFE
Participants will receive Treatment B in treatment period 1, followed by Treatment C in treatment period 2, Treatment A in treatment period 3, Treatment D in treatment period 4, Treatment F in treatment period 5 and then Treatment E in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.
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.
Treatment Phase: Treatment Sequence CDBEAF
Participants will receive Treatment C in treatment period 1, followed by Treatment D in treatment period 2, Treatment B in treatment period 3, Treatment E in treatment period 4, Treatment A in treatment period 5 and then Treatment F in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.
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.
Treatment Phase: Treatment Sequence DECFBA
Participants will receive Treatment D in treatment period 1, followed by Treatment E in treatment period 2, Treatment C in treatment period 3, Treatment F in treatment period 4, Treatment B in treatment period 5 and then Treatment A in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.
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.
Treatment Phase: Treatment Sequence: EFDACB
Participants will receive Treatment E in treatment period 1, followed by Treatment F in treatment period 2, Treatment D in treatment period 3, Treatment A in treatment period 4, Treatment C in treatment period 5 and then Treatment B in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.
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.
Treatment Phase: Treatment Sequence FAEBDC
Participants will receive Treatment F in treatment period 1, followed by Treatment A in treatment period 2, Treatment E in treatment period 3, Treatment B in treatment period 4, Treatment D in treatment period 5 and Treatment C in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Altasciences Inc.
Overland Park, Kansas, United States
Countries
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Other Identifiers
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42847922MDD1017
Identifier Type: OTHER
Identifier Source: secondary_id
CR109099
Identifier Type: -
Identifier Source: org_study_id
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