Actively Recruiting
Suvorexant as an Adjunct to Buprenorphine Induction and Maintenance in Persons Who Use Fentanyl
Led by Johns Hopkins University · Updated on 2025-08-11
120
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating suvorexant alongside buprenorphine treatment in adults with opioid use disorder who have recently used fentanyl. This phase 2 randomized-controlled trial aims to compare suvorexant against a placebo to assess its effects during buprenorphine induction and maintenance. Participants must have evidence of fentanyl exposure and meet criteria for opioid dependence to take part in this study. The study consists of a 5-day residential phase followed by a 3-week outpatient phase. During the residential phase, participants are stabilized on sublingual buprenorphine or buprenorphine/naloxone and receive either nightly suvorexant or placebo. In the outpatient phase, they continue sublingual buprenorphine/naloxone and study medication managed by an automated pill dispenser. At the study's end, participants receive an injection of extended-release buprenorphine. Both study medication and buprenorphine treatments are administered openly following standard care. Participant involvement includes urine testing for fentanyl exposure, forehead EEG monitoring, and wrist-worn devices that track activity and physiological signals. Questionnaires are completed in person and via cell phone-based assessments. Researchers measure total sleep time during the residential phase and monitor adherence to buprenorphine over the 25-day treatment period. The study includes close safety and treatment compliance monitoring, lasting approximately four weeks per participant.
CONDITIONS
Brief 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 evidence of physical dependence
- Provides urine sample positive for fentanyl or fentanyl analogues
- Interested in maintenance treatment with buprenorphine
- Plans to reside in current area for study duration
- Achieves maintenance dose of at least 8 mg sublingual buprenorphine/naloxone
- Willing to follow study protocol
- No clinically significant chronic medical or surgical conditions preventing participation as judged by investigators
You will not qualify if you...
- Medically contraindicated for buprenorphine, extended-release buprenorphine, or suvorexant
- Pregnant or breastfeeding
- Severe alcohol or benzodiazepine use disorder or physical dependence
- Known allergy to study medications
- Use of suvorexant prescribed for insomnia in past 30 days
- Current benzodiazepine or other prescribed insomnia medication use
- Urine positive for benzodiazepines at screening or 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
- Clinically significant psychiatric condition interfering with participation in past year
- Lack of stable housing needed for electronic pill dispenser charging
- Circumstances interfering with participation, such as impending incarceration
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks total (5-day residential phase plus ~3-week outpatient phase)
Participants are treated with nightly dosing of suvorexant or placebo alongside buprenorphine induction and maintenance. This includes a 5-day residential phase with short-acting opioid maintenance and buprenorphine induction followed by a 3-week outpatient phase with continued buprenorphine/naloxone and study medication managed by an automated pill dispenser.
1 residential stay of 5 days and weekly outpatient visits for up to 3 weeks
Duration - Single visit at end of study
At the end of the treatment phase, participants receive an injection of extended-release buprenorphine (Sublocade) and continue to be monitored for treatment compliance and sleep outcomes.
1 injection visit (in-person)
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.
K
Kelly E Dunn, Ph.D.
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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