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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
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 moreSide effects data
From 2023 Phase 2 trial • 88 Patients • NCT053076923%
Pancreatic Neuroendocrine Tumour
3%
Pruritus
3%
Malignant Biliary Obstruction
3%
Orchitis
3%
Neck Pain
3%
Tension Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB: Placebo
FU: Seltorexant
DB: Seltorexant
Follow-up (FU): Placebo
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
~2200
Placebo
1995
Completed Phase 3
~2670
Zolpidem
2003
Completed Phase 4
~2490
Seltorexant
2021
Completed Phase 3
~1700
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,402,243 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,980,270 Total Patients Enrolled