Measuring Acute Drug Demand in Humans

Opioid Use Disorder Clinical Trial

Official title:

Measuring Acute Drug Demand in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829655
• Other study ID #: IRB00344798
• Secondary ID: R01DA055634
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 8, 2023
• Est. completion date: October 31, 2027

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: Justin Strickland, PhD
• Phone: (410) 550-1975
• Email: jstric14[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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 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.

Locations

Country	Name	City	State
United States	Behavioral Pharmacology Research Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Upon completion of experimental session (~8 hours post drug administration)
Primary	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).	Upon completion of experimental session (~8 hours post drug administration)
Primary	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.	After Experimental Session 4
Secondary	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.	Through study completion, up to two weeks