Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder
Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
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) or methadone. Within the XR-NTX
(n=100) and methadone (n=100) groups, participants will be randomized to either suvorexant
(n=50 in each MAT) or placebo (n=50 in each MAT). The study is expected to have a 20%
treatment attrition rate which will result in N=160 completers in the entire study and n=80
completers within each MAT group. XR-NTX patients will be recruited from and treated at
Ashley Addiction Treatment. Methadone patients will be recruited from and treated at
Addiction Treatment Services at Johns Hopkins Bayview Medical Center.