Measuring Acute Drug Demand in Humans

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

Detailed Description
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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 Johns Hopkins Bayview Medical Center. 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.

Official Title
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Measuring Acute Drug Demand in Humans

Conditions
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Opioid Use Disorder, Opioid Dependence

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suvorexant (20mg/day)<br>Double blind administration of suvorexant once per day during residential stay until discharge | Drug: Drug A (Blinded Drug)<br>* 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).<br>Drug: Drug B (Blinded Drug)<br>* 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).<br>Drug: Drug C (Blinded Drug)<br>* 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).<br>Drug: Drug D (Blinded Drug)<br>* 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).<br>Drug: Suvorexant (20mg/day)<br>* Double blind administration of suvorexant once per day during residential stay until discharge.<br>|
| Placebo Comparator: Placebo<br>Double blind administration of placebo once per day during residential stay until discharge | Drug: Drug A (Blinded Drug)<br>* 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).<br>Drug: Drug B (Blinded Drug)<br>* 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).<br>Drug: Drug C (Blinded Drug)<br>* 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).<br>Drug: Drug D (Blinded Drug)<br>* 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).<br>Drug: Placebo<br>* Double blind administration of placebo once per day during residential stay until discharge.<br>|

What is the study measuring?
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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 |