Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05145764
Phase
PHASE2
Status
Recruiting
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Conditions

  • Opioid Use Disorder
  • Placebo
  • Suvorexant

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Suvorexant — DRUG
    Encapsulated suvorexant (matched for color, weight, and size)
  • Placebo — DRUG
    Encapsulated placebo (matched for color, weight, and size)

Study Details

This is a 4-week, randomized-controlled trial of suvorexant vs placebo in persons with opioid use disorder who have recent fentanyl exposure. Participants will first undergo a 5-day residential phase wherein participants are stabilized on sublingual buprenorphine/naloxone, followed by a 3-week outpatient phase wherein participants are maintained on sublingual buprenorphine/naloxone and transitioned to extended-release buprenorphine).

Key Dates

Start date
Mar 30, 2022
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Suvorexant
    Nightly dosing of suvorexant
  • Placebo Comparator: Placebo
    Nightly dosing of placebo

Primary Outcome Measure

Total Sleep Time [ Time Frame: 3 nights during the initial residential phase and 1 night at the end of outpatient treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224
Andrew S Huhn, Ph.D.
[email protected]
410-550-1971

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Bayview Medical Center· Baltimore, MD

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