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Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder
Sponsor: Johns Hopkins University
Summary
This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.
Key Details
Gender
All
Age Range
21 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2020-11-20
Completion Date
2025-08-15
Last Updated
2026-08-25
Healthy Volunteers
No
Conditions
Interventions
Suvorexant
Dual orexin receptor antagonist
Placebos
Weight and color matched placebo
Locations (5)
Man Alive Inc., Lane Treatment Center
Baltimore, Maryland, United States
Addiction Treatment Services at Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Ashley Addiction Treatment
Bel Air, Maryland, United States
Ashley Addiction Treatment
Elkton, Maryland, United States