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NCT Number: NCT05829655

Measuring Acute Drug Demand in Humans

This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

General Clinical Research Center

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

Justin Strickland, PhD

CONTACT

[email protected]

667-354-3516

Justin Strickland, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

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).

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).

Suvorexant (20mg/day)

Drug

Double blind administration of suvorexant once per day during residential stay until discharge.

Placebo

Drug

Double blind administration of placebo once per day during residential stay until discharge.

Primary outcomes

  1. Demand Intensity

    Time frame: 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).

  2. Demand Elasticity

    Time frame: 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).

  3. Cross-Price Elasticity

    Time frame: 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 outcomes

  1. Total Mean Sleep Time

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Justin Strickland, PhD

CONTACT

[email protected]

667-354-3516

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 26, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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