Recruiting
Early Phase 1

Observational Study

Sponsor:

University of Maryland, Baltimore

Code:

NCT05829655

Conditions

Opioid Use Disorder

Opioid Dependence

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Drug A (Blinded Drug)

Drug B (Blinded Drug)

Drug C (Blinded Drug)

Drug D (Blinded Drug)

Suvorexant (20mg/day)

Study Details

Brief summary:

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

Conditions

Opioid Use Disorder

Opioid Dependence

Study ID

NCT05829655

Start date

Aug 8, 2023

Status verified date

Jun, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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

Interventions

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 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 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 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).

Suvorexant (20mg/day)

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

Placebo

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Justin Strickland, PhD

667-354-3516jstrickland@som.umaryland.edu

Locations

General Clinical Research Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Justin Strickland, PhD

667-354-3516jstrickland@som.umaryland.edu

Principal Investigator:

Justin Strickland, PhD

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-06-23.