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

NCT04262193 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: DORA, Sleep and Opioid Use
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Opioid abstinence

  Percentage of opioid-free urine drug screens (UDS)

  up to 13 weeks

• Sleep efficiency

  Sleep efficiency equals sleep time (determined by standardized scoring of electroencephalogram recordings) divided by time in bed

  Sleep efficiency is measured on the evening of the first medication dose

Secondary Outcomes (9)

• Daily sleep questionnaire

  Change in sleep quality scores from inpatient stay to outpatient weeks 2, 6 and 10

• Actigraphic assessment of sleep

  Change in total activity counts across outpatient weeks 2, 6 and 10

• Weekly sleep questionnaire

  Change in sleep quality scores across outpatient weeks 1, 4, 8 and 12

• Timeline followback interview assessment of substance use

  Once weekly (in conjunction with urine drug screen) on outpatient weeks 1 through 13

• Urinary cortisol

  Measured at 11pm on nights 4, 6, 8 (coordinated with sleep efficiency and melatonin assessments) and the following day (7am and 3pm on days 5, 7, 9) on the inpatient unit

Study Arms (2)

Suvorexant placebo

PLACEBO COMPARATOR

Placebo (inert) tablet

Drug: Suvorexant Placebo

Suvorexant 20mg

EXPERIMENTAL

Suvorexant 20mg tablet

Drug: Suvorexant

Interventions

Suvorexant DRUG

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

Also known as: Belsomra

Suvorexant 20mg

Suvorexant Placebo DRUG

Suvorexant Placebo

Suvorexant placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years old
• Males and non-pregnant females who agree to medically accepted birth control for the duration of the study
• Meet DSM-5 criteria for opioid use disorder (any severity level) alone or comorbid with stable medical diseases (except for certain medications \[see below\])

You may not qualify if:

• Body mass index \>38
• Acute/unstable illness: conditions making it unsafe for participation, conditions with potential to disturb sleep (i.e. acute pain, respiratory infection)
• Chronic illnesses; renal failure, liver disease, seizures, and dementing illnesses
• Current psychiatric disease: psychosis, bipolar disorder, PTSD
• Smoking during the night (11pm-7am). Nicotine replacement therapy is allowed
• Medications including anxiolytics, hypnotics (both prescription and OTC), sedating antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H4 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented
• Sleep-disordered breathing and periodic leg movements (PLMs) defined as ≥ 10 apnea-hypopneas or PLM events related to EEG arousal per hour of sleep time, or any other primary sleep (e.g. narcolepsy, restless legs syndrome) or circadian disorder
• Night-shift work, which would alter circadian rhythm and be a confound in this trial.

Sponsors & Collaborators

• Wayne State University: lead
• Henry Ford Health System: collaborator
• Ascension Brighton Center for Recovery: collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Mark K Greenwald, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Suvorexant (20mg) and placebo research tablets will appear identical.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Neurosciences; and Director, Substance Abuse Research Division

Model Details: Participants will be randomly assigned to one of the 2 parallel groups for the duration of the study.

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: February 1, 2021
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Electronic copies of publications will be deposited within 4 weeks of acceptance. Underlying primary data will be made publicly available as soon as possible (time frame to be determined).
• Access Criteria: De-identified data (still being processed) will be placed in the NSRR (National Sleep Research Resource) repository.

Locations

US (1)