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Dual-Orexin Antagonism As a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder

NCT04262193 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-09-25

No results posted yet for this study

Summary

Summary of Study Protocol. This project is designed to test neurobehavioral mechanisms underlying effects of the dual orexin-1/2 receptor antagonist suvorexant on sleep efficiency and opioid abstinence, and whether these outcomes are independent of one another. This will be the first study to investigate whether suvorexant improves outpatient opioid abstinence and sleep efficiency; and whether improving sleep mediates the improved opioid abstinence outcome. 120 participants with opioid use disorder (OUD) will complete this intent-to-treat study.

Conditions

  • Opioid-use Disorder
  • Sleep

Interventions

DRUG

Suvorexant

In each group, the participant will take 1 tablet (placebo or 20mg) 30 minutes before bedtime.

DRUG

Suvorexant Placebo

Suvorexant Placebo

Sponsors & Collaborators

  • Henry Ford Health System

    collaborator OTHER

  • Ascension Brighton Center for Recovery

    collaborator UNKNOWN

  • Wayne State University

    lead OTHER

Principal Investigators

  • Mark K Greenwald, PhD · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2024-07-30
Completion
2024-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04262193 on ClinicalTrials.gov