Measuring Acute Drug Demand in Humans
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Maryland, Baltimore
About this trial
This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Drug A (Blinded Drug)
DrugParticipants 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 B (Blinded Drug)
DrugParticipants 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 C (Blinded Drug)
DrugParticipants 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 D (Blinded Drug)
DrugParticipants 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).
Suvorexant (20mg/day)
DrugDouble blind administration of suvorexant once per day during residential stay until discharge.
Placebo
DrugDouble blind administration of placebo once per day during residential stay until discharge.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Suvorexant (20mg/day)Experimental treatment 5 interventions
Group B: PlaceboPlacebo comparator 5 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Upon completion of experimental session (~8 hours post drug administration)2
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).
Time frame
Upon completion of experimental session (~8 hours post drug administration)3
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.
Time frame
After Experimental Session 4Secondary outcomes
1
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.
Time frame
Through study completion, up to two weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov