Measuring Acute Drug Demand in Humans
- Conditions
- Opioid Use DisorderOpioid Dependence
- Interventions
- Drug: Drug A (Blinded Drug)Drug: Drug B (Blinded Drug)Drug: Drug C (Blinded Drug)Drug: Drug D (Blinded Drug)Drug: Placebo
- Registration Number
- NCT05829655
- Lead Sponsor
- Johns Hopkins University
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Suvorexant (20mg/day) Drug A (Blinded Drug) Double blind administration of suvorexant once per day during residential stay until discharge Suvorexant (20mg/day) Drug B (Blinded Drug) Double blind administration of suvorexant once per day during residential stay until discharge Suvorexant (20mg/day) Drug C (Blinded Drug) Double blind administration of suvorexant once per day during residential stay until discharge Suvorexant (20mg/day) Drug D (Blinded Drug) Double blind administration of suvorexant once per day during residential stay until discharge Suvorexant (20mg/day) Suvorexant (20mg/day) Double blind administration of suvorexant once per day during residential stay until discharge Placebo Drug A (Blinded Drug) Double blind administration of placebo once per day during residential stay until discharge Placebo Drug B (Blinded Drug) Double blind administration of placebo once per day during residential stay until discharge Placebo Drug C (Blinded Drug) Double blind administration of placebo once per day during residential stay until discharge Placebo Drug D (Blinded Drug) Double blind administration of placebo once per day during residential stay until discharge Placebo Placebo Double blind administration of placebo once per day during residential stay until discharge
- Primary Outcome Measures
Name Time Method 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).
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).
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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Behavioral Pharmacology Research Unit
🇺🇸Baltimore, Maryland, United States