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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA055634 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suvorexant (20mg/day) | Experimental | Double blind administration of suvorexant once per day during residential stay until discharge |
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| Placebo | Placebo Comparator | Double blind administration of placebo once per day during residential stay until discharge |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug A (Blinded Drug) | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justin Strickland, PhD | Contact | 667-354-3516 | jstrickland@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Justin Strickland, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Center | Recruiting | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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| Drug B (Blinded Drug) | 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). |
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| Drug C (Blinded Drug) | 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). |
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| Drug D (Blinded Drug) | 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). |
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| Suvorexant (20mg/day) | Drug | Double blind administration of suvorexant once per day during residential stay until discharge. |
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| Placebo | Drug | Double blind administration of placebo once per day during residential stay until discharge. |
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