Measuring Acute Drug Demand in Humans

Johns Hopkins University

Status and phase: Enrolling; Early Phase 1

Conditions: Opioid Use Disorder; Opioid Dependence

Treatments: Drug: Drug D (Blinded Drug); Drug: Drug C (Blinded Drug); Drug: Drug A (Blinded Drug); Drug: Placebo; Drug: Suvorexant (20mg/day); Drug: Drug B (Blinded Drug)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05829655

R01DA055634 (U.S. NIH Grant/Contract)

IRB00344798

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 2 patient groups, including a placebo group

Suvorexant (20mg/day)

Experimental group

Description:

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

Treatment:

Drug: Suvorexant (20mg/day)

Drug: Drug B (Blinded Drug)

Drug: Drug A (Blinded Drug)

Drug: Drug D (Blinded Drug)

Drug: Drug C (Blinded Drug)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Drug B (Blinded Drug)

Drug: Placebo

Drug: Drug A (Blinded Drug)

Drug: Drug D (Blinded Drug)

Drug: Drug C (Blinded Drug)