NCT05829655

Measuring Acute Drug Demand in Humans

• Status: Suspended
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs. Suvorexant is not approved as a treatment to reduce drug use but is approved by the Food and Drug Administration (FDA) to treat insomnia (trouble falling asleep or staying asleep). This study consists of a screening visit and an approximate 14 to 16 day inpatient (overnight) stay at the University of Maryland, Baltimore. Participants will be stabilized on hydromorphone, randomly assigned to receive either suvorexant or placebo, and complete 5 experimental sessions that include taking blinded study medications.

Conditions

• Opioid Use Disorder
• Opioid Dependence

Interventions

Type	Name	Description
DRUG	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	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	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	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).
DRUG	Suvorexant (20mg/day)	Double blind administration of suvorexant once per day during residential stay until discharge.
DRUG	Placebo	Double blind administration of placebo once per day during residential stay until discharge.

Timeline

• Start date: 2023-08-08
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2023-04-26
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study