Actively Recruiting
Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
Led by Johns Hopkins University · Updated on 2025-08-11
120
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-65
- Meets DSM-5 criteria for opioid use disorder with physical dependence
- Urine test positive for fentanyl and/or fentanyl analogues
- Interested in maintenance treatment with buprenorphine
- Plans to live in current area during study
- Achieves maintenance dose of at least 8mg sublingual buprenorphine/naloxone
- Willing to follow the study protocol
- No clinically significant chronic medical or surgical conditions preventing participation
You will not qualify if you...
- Medically unable to take buprenorphine, extended-release buprenorphine, or suvorexant
- Pregnant or breastfeeding
- Severe alcohol or benzodiazepine use disorder or physical dependence
- Known allergy to study medications
- Prescribed suvorexant for insomnia in past 30 days
- Current benzodiazepine or other insomnia medication use
- Urine test positive for benzodiazepines at screening or residential admission
- Current narcolepsy, restless leg syndrome, or sleep paralysis
- High risk for sleep apnea
- Suicidal behaviors in past 30 days
- Severe liver or kidney impairment (specific lab values over limits)
- Significant psychiatric condition interfering with participation
- No stable housing for pill dispenser charging
- Other circumstances interfering with participation (e.g., impending jail)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
A
Andrew S Huhn, Ph.D.
CONTACT
K
Kelly E Dunn, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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