Study Stopped
The trial is currently paused during a move to a new institution and acquisition of the new IRB approval at University of Maryland, Baltimore
Measuring Acute Drug Demand in Humans
2 other identifiers
interventional
75
1 country
1
Brief Summary
This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2023
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2023
CompletedFirst Posted
Study publicly available on registry
April 26, 2023
CompletedStudy Start
First participant enrolled
August 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
February 18, 2026
February 1, 2026
4.2 years
April 13, 2023
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Total Mean Sleep Time
Through study completion, up to two weeks
Study Arms (2)
Suvorexant (20mg/day)
EXPERIMENTALDouble blind administration of suvorexant once per day during residential stay until discharge
Placebo
PLACEBO COMPARATORDouble blind administration of placebo once per day during residential stay until discharge
Interventions
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).
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).
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).
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).
Double blind administration of suvorexant once per day during residential stay until discharge.
Double blind administration of placebo once per day during residential stay until discharge.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Clinical Research Center
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justin Strickland, PhD
University of Maryland, Baltimore
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2023
First Posted
April 26, 2023
Study Start
August 8, 2023
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
February 18, 2026
Record last verified: 2026-02