Opioid Dependence, Opioid Use Disorder
Conditions
Brief 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.
Interventions
DRUGDrug 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).
DRUGDrug 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).
DRUGDrug 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).
DRUGDrug 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).
DRUGSuvorexant (20mg/day)
Double blind administration of suvorexant once per day during residential stay until discharge.
DRUGPlacebo
Double blind administration of placebo once per day during residential stay until discharge.
Sponsors
University of Maryland, Baltimore
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demand Intensity | Upon completion of experimental session (~8 hours post drug administration) | 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). |
| Demand Elasticity | Upon completion of experimental session (~8 hours post drug administration) | 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). |
| Cross-Price Elasticity | After Experimental Session 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Mean Sleep Time | Through study completion, up to two weeks | 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. |
Countries
United States
Contacts
CONTACTJustin Strickland, PhD
PRINCIPAL_INVESTIGATORJustin Strickland, PhD
University of Maryland, Baltimore
Outcome results
None listed