Measuring Acute Drug Demand in Humans

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

General Clinical Research Center
Baltimore, Maryland 21201
Contact:
Justin Strickland, PhD
667-354-3516
jstrickland@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Justin Strickland, PhD
667-354-3516
jstrickland@som.umaryland.edu

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.