← Back to Search

Orexin Antagonist

Seltorexant for Addiction

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

Summary

This trial tests if seltorexant can be misused like other sleeping pills by comparing it to a harmless pill and two common sedatives. It focuses on people who use sedatives recreationally but are not dependent on them. Seltorexant may help reduce excessive arousal and depressive symptoms.

Eligible Conditions

Addiction
Recreational Sedative Users

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 hour and 24 hour post-dose

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS)

Secondary study objectives

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

Placebo

1995

Completed Phase 3

~2670

Suvorexant

2016

Completed Phase 4

~2200