NCT04287062

Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disturbance
• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Suvorexant	Dual orexin receptor antagonist
DRUG	Placebos	Weight and color matched placebo

Timeline

• Start date: 2020-11-20
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2020-02-27
• Last updated: 2025-11-20

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study