Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
75 participants
INTERVENTIONAL
2023-08-08
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Suvorexant (20mg/day)
Double blind administration of suvorexant once per day during residential stay until discharge
Drug A (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug B (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug C (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug D (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Suvorexant (20mg/day)
Double blind administration of suvorexant once per day during residential stay until discharge.
Placebo
Double blind administration of placebo once per day during residential stay until discharge
Drug A (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug B (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug C (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug D (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Placebo
Double blind administration of placebo once per day during residential stay until discharge.
Interventions
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Drug A (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug B (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug C (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug D (Blinded Drug)
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Suvorexant (20mg/day)
Double blind administration of suvorexant once per day during residential stay until discharge.
Placebo
Double blind administration of placebo once per day during residential stay until discharge.
Eligibility Criteria
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Inclusion Criteria
* Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe)
* Lifetime substance use history criterion \[blinded\]
* Medically cleared to take suvorexant and blinded study medications
* Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
Exclusion Criteria
* Seeking opioid use treatment
* Significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff
* Known contraindications or allergies to suvorexant and/or the blinded study medications
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Justin Strickland, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00344798
Identifier Type: -
Identifier Source: org_study_id
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