RecruitingEarly Phase 1NCT05829655

Measuring Acute Drug Demand in Humans


Sponsor

University of Maryland, Baltimore

Enrollment

75 participants

Start Date

Aug 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • Age between 18 and 65 years old
  • 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 Criteria4

  • Pregnant or breast feeding
  • 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

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Interventions

DRUGDrug 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).

DRUGDrug 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).

DRUGDrug 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).

DRUGDrug 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).

DRUGSuvorexant (20mg/day)

Double blind administration of suvorexant once per day during residential stay until discharge.

DRUGPlacebo

Double blind administration of placebo once per day during residential stay until discharge.


Locations(1)

General Clinical Research Center

Baltimore, Maryland, United States

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NCT05829655


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