Measuring Acute Drug Demand in Humans

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

Study Overview

• Status: Suspended
• Conditions: Opioid Use Disorder; Opioid Dependence
• Intervention / Treatment: Drug: Drug A (Blinded Drug); Drug: Drug B (Blinded Drug); Drug: Drug C (Blinded Drug); Drug: Drug D (Blinded Drug); Drug: Suvorexant (20mg/day); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • General Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suvorexant (20mg/day); Double blind administration of suvorexant once per day during residential stay until discharge	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.
Placebo Comparator: Placebo; Double blind administration of placebo once per day during residential stay until discharge	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: Placebo; Double blind administration of placebo once per day during residential stay until discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demand Intensity	Consumption of blinded drug at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more drug consumption at unconstrained price (a worse outcome).	Upon completion of experimental session (~8 hours post drug administration)
Demand Elasticity	Changes in blinded drug consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater drug price sensitivity (a better outcome).	Upon completion of experimental session (~8 hours post drug administration)
Cross-Price Elasticity	Change in consumption of price-fixed good based on change in price of price varying good. Positive values indicate a substitute, negative values indicate a complement, and zero values indicate an independent commodity.	After Experimental Session 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Mean Sleep Time	Mean total number of minutes slept per night as measured by actigraphy and self-reported sleep diary. Mean total sleep time will be collected daily.	Through study completion, up to two weeks

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Justin Strickland, PhD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Sleep Aids, Pharmaceutical; Orexin Receptor Antagonists; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Neurotransmitter Agents; Hypnotics and Sedatives; suvorexant
• Other Study ID Numbers: HP-00116510; R01DA055634 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No