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Orexin Antagonist

Seltorexant for Substance Abuse

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 hour and 24 hour post-dose
Awards & highlights

Study Summary

This trial is testing if a new sleep medication is more likely to be abused than other similar medications.

Eligible Conditions
  • Substance Abuse Potential
  • Recreational Sedative Users

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 hour and 24 hour post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hour and 24 hour post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS)
Secondary outcome measures
Drug Similarity VAS
Emax of Any Effects VAS
Emax of Bad Effects VAS
+32 more

Trial Design

12Treatment groups
Experimental Treatment
Group I: Treatment Phase: Treatment Sequence: EFDACBExperimental Treatment4 Interventions
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.
Group II: Treatment Phase: Treatment Sequence FAEBDCExperimental Treatment4 Interventions
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.
Group III: Treatment Phase: Treatment Sequence DECFBAExperimental Treatment4 Interventions
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.
Group IV: Treatment Phase: Treatment Sequence CDBEAFExperimental Treatment4 Interventions
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.
Group V: Treatment Phase: Treatment Sequence BCADFEExperimental Treatment4 Interventions
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.
Group VI: Treatment Phase: Treatment Sequence ABFCEDExperimental Treatment4 Interventions
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.
Group VII: Qualification Phase: Treatment Sequence ZYXExperimental Treatment3 Interventions
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.
Group VIII: Qualification Phase: Treatment Sequence ZXYExperimental Treatment3 Interventions
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.
Group IX: Qualification Phase: Treatment Sequence YZXExperimental Treatment3 Interventions
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.
Group X: Qualification Phase: Treatment Sequence YXZExperimental Treatment3 Interventions
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.
Group XI: Qualification Phase: Treatment Sequence XZYExperimental Treatment3 Interventions
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.
Group XII: Qualification Phase: Treatment Sequence XYZExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant
2016
Completed Phase 4
~2120
Zolpidem
2003
Completed Phase 4
~2530
Seltorexant
2021
Completed Phase 3
~1090
Placebo
1995
Completed Phase 3
~2670

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
978 Previous Clinical Trials
6,384,942 Total Patients Enrolled
1 Trials studying Substance Abuse
55 Patients Enrolled for Substance Abuse
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
747 Previous Clinical Trials
3,960,520 Total Patients Enrolled
1 Trials studying Substance Abuse
55 Patients Enrolled for Substance Abuse
~37 spots leftby May 2025
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