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COMPLETED
NCT04287062
PHASE2

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

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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

Interventions

DRUG

Suvorexant

Dual orexin receptor antagonist

DRUG

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