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Recruiting NCT05829655

Measuring Acute Drug Demand in Humans

Early Phase I Interventional Opioid Use Disorder Opioid Dependence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drug A (Blinded Drug), Drug B (Blinded Drug), Drug C (Blinded Drug), Drug D (Blinded Drug).
Who it may be relevant to
Registry conditions: Opioid Use Disorder, Opioid Dependence. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug Drug 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).
  • Drug Drug 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).
  • Drug Drug 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).
  • Drug Drug 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).
  • Drug Suvorexant (20mg/day)
    Double blind administration of suvorexant once per day during residential stay until discharge.
  • Drug Placebo
    Double blind administration of placebo once per day during residential stay until discharge.

Primary outcome measures

  • Demand Intensity [Time frame: Upon completion of experimental session (~8 hours post drug administration)]
  • Demand Elasticity [Time frame: Upon completion of experimental session (~8 hours post drug administration)]
  • Cross-Price Elasticity [Time frame: After Experimental Session 4]
Secondary outcome measures (1)
  • Total Mean Sleep Time [Time frame: Through study completion, up to two weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • General Clinical Research Center — Baltimore

Identifiers

NCT: NCT05829655 · HP-00116510 · R01DA055634

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗