Back to resultsMeasuring Acute Drug Demand in Humans
Primary Purpose
Opioid Use Disorder, Opioid Dependence
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Drug A (Blinded Drug)
Drug B (Blinded Drug)
Drug C (Blinded Drug)
Drug D (Blinded Drug)
Suvorexant (20mg/day)
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Opioid Use Disorder
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
Sites / Locations
- Behavioral Pharmacology Research UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Suvorexant (20mg/day)
Placebo
Arm Description
Double blind administration of suvorexant once per day during residential stay until discharge
Double blind administration of placebo once per day during residential stay until discharge
Outcomes
Primary Outcome Measures
Demand Intensity
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).
Demand Elasticity
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).
Cross-Price Elasticity
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 Outcome Measures
Total Mean Sleep Time
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.
Full Information
NCT ID
NCT05829655
First Posted
April 13, 2023
Last Updated
August 9, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05829655
Brief Title
Measuring Acute Drug Demand in Humans
Official Title
Measuring Acute Drug Demand in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
April 2029 (Anticipated)
Study Completion Date
April 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 Johns Hopkins Bayview Medical Center. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Opioid Dependence
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Suvorexant (20mg/day)
Arm Type
Experimental
Arm Description
Double blind administration of suvorexant once per day during residential stay until discharge
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Double blind administration of placebo once per day during residential stay until discharge
Intervention Type
Drug
Intervention Name(s)
Drug A (Blinded Drug)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Drug B (Blinded Drug)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Drug C (Blinded Drug)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Drug D (Blinded Drug)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Suvorexant (20mg/day)
Intervention Description
Double blind administration of suvorexant once per day during residential stay until discharge.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Double blind administration of placebo once per day during residential stay until discharge.
Primary Outcome Measure Information:
Title
Demand Intensity
Description
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).
Time Frame
Upon completion of experimental session (~8 hours post drug administration)
Title
Demand Elasticity
Description
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).
Time Frame
Upon completion of experimental session (~8 hours post drug administration)
Title
Cross-Price Elasticity
Description
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.
Time Frame
After Experimental Session 4
Secondary Outcome Measure Information:
Title
Total Mean Sleep Time
Description
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.
Time Frame
Through study completion, up to two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Strickland, PhD
Phone
(410) 550-1975
Email
jstric14@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Strickland, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Pharmacology Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Strickland, PhD
Phone
410-550-1975
Email
jstric14@jhmi.edu
12. IPD Sharing Statement
Learn more about this trial
Measuring Acute Drug Demand in Humans
We'll reach out to this number within 24 hrs