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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

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
975 Previous Clinical Trials
6,384,181 Total Patients Enrolled
1 Trials studying Substance Abuse
55 Patients Enrolled for Substance Abuse
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,778 Total Patients Enrolled
1 Trials studying Substance Abuse
55 Patients Enrolled for Substance Abuse

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be a contributor to this research endeavor?

"To qualify for this research, participants should be between 18 and 60 years old and have a history engaging in healthy non-dependent recreational sedative use. This experiment has the capacity to accept 200 individuals."

Answered by AI

What has been the regulatory approval status of Seltorexant?

"The safety of seltorexant is only partially understood, earning it a score of 1 on our risk assessment scale. This phase one trial has not yet yielded sufficient evidence to substantiate its efficacy or safety conclusively."

Answered by AI

Does the criteria for this experiment include persons over 50 years of age?

"This clinical study is only available to those aged between 18 and 60. There are, however, 1 trial for minors and 20 trials aimed at the elderly population."

Answered by AI

Is this trial currently open to new participants?

"This clinical trial is still open for recruitment, as evidenced by the most recent update to the info on clinicialtrials.gov dated November 9th 2022. The study was initially listed on December 17th 2021."

Answered by AI

What is the aggregate amount of participants in this research project?

"Affirmative. The information hosted on clinicaltrials.gov reveals that this medical study is actively enrolling patients, having been initially posted on December 17th 2021 and recently updated on November 9th 2022. This trial needs to recruit 200 individuals from a single site."

Answered by AI

What other research studies have been done with Seltorexant?

"Currently, 23 research projects are evaluating Seltorexant's efficacy. 4 of them have progressed to the third phase and encompass 494 locations, most notably Silver Spring in Maryland."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem
2021. "A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05106153.
~38 spots leftby Apr 2025
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