Measuring Acute Drug Demand in Humans

June 19, 2026 updated by: University of Maryland, Baltimore
This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • General Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Justin Strickland, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Suvorexant (20mg/day)
Double blind administration of suvorexant once per day during residential stay until discharge
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.
Placebo Comparator: Placebo
Double blind administration of placebo once per day during residential stay until discharge
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: Placebo
Double blind administration of placebo once per day during residential stay until discharge.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Upon completion of experimental session (~8 hours post drug administration)
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).
Upon completion of experimental session (~8 hours post drug administration)
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.
After Experimental Session 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, up to two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, Baltimore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Justin Strickland, PhD, University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HP-00116510
  • R01DA055634 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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