NCT05829655EARLY_PHASE1RecruitingAccepts Healthy Volunteers

Measuring Acute Drug Demand in Humans

University of Maryland, Baltimore

Start Date

8/8/2023

Completion Date

1/1/2028

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 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.

Eligibility Criteria

Age Range: 18 years to 65 years

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

Interventions

DRUG

Drug A (Blinded Drug)

DRUG

Drug B (Blinded Drug)

DRUG

Drug C (Blinded Drug)

DRUG

Drug D (Blinded Drug)

DRUG

Suvorexant (20mg/day)

DRUG

Placebo

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Conditions

Opioid Use DisorderOpioid Dependence

Locations

General Clinical Research Center

Baltimore, Maryland 21201

United States