Sleep DisturbancePhase 2NCT04287062
Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder
A Phase 2 study testing Suvorexant in people with Sleep Disturbance and Opioid-use Disorder, run by Johns Hopkins University at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Sleep Disturbance, Opioid-use Disorder
- What is being tested?
- Suvorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Nov 2020to 15 Aug 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 21-65, inclusive.
- Past 30-day sleep disturbance as evidenced by a Pittsburgh Sleep Quality Index Total Score >5.
- Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, or XR-NTX treatment for OUD.
- Willingness to be maintained on a protocolized dose starting between 60-130mg methadone or 380mg XR-NTX for the duration of the study.
- At least two weeks of continuous abstinence from illicit opioids as evidenced by self-report and urine drug screens collected as part of routine care.
- Willing to comply with the study protocol, which will include weekly study visits, daily actigraphy and ecological momentary assessments.
- Use of birth control throughout study.
- Have no clinically significant chronic medical disorders or conditions that are judged by the investigators to prevent participation.
Who cannot join
- Serious mental illnesses that are unstable and could affect study participation (thought disorders, hallucinations, delusions, thoughts of harm to self/others).
- Current moderate to severe substance use disorder other than OUD.
- Current illicit stimulant use, including cocaine and methamphetamine.
- Pregnant or breast feeding.
- Have a known allergy to the study medications.
- Past 30-day prescribed use of suvorexant.
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- Current use of a benzodiazepine or other schedule IV medication for insomnia.
- Use of Cytochrome P450 3A inhibitors.
- Current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medical history
- Apnea-hypopnea index > 30.
- Use of glucocorticoid medications and any medication that would alter the hypothalamic-pituitary-adrenal axis.
- Past 30-day suicidal behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
- Have circumstances that would interfere with study participation (e.g., impending jail; severe clinical issues).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Man Alive Inc., Lane Treatment Center
Baltimore, Maryland, 21218
Addiction Treatment Services at Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Ashley Addiction Treatment
Bel Air, Maryland, 21014
Ashley Addiction Treatment
Elkton, Maryland, 21921
About this study
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
- Being tested
- Suvorexant, Placebos
- Medical subject headings
- Parasomnias, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuvorexantDrug
Dual orexin receptor antagonist
PlacebosDrug
Weight and color matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo sleep medication (2 placebo oral capsules) Receives: Drug: Placebos |
| Suvorexant | Active comparator | Sleep medication (20mg suvorexant; 2 10mg capsules; patients can self-titrate to 1 10mg capsule) Receives: Drug: Suvorexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
Mean total number of minutes slept per night as measured by actigraphy and self-reported sleep diary. Mean total sleep time will be collected over a seven-night period in weeks 0, 1, 4, and 8 of the trial.
Measured: 28 days (collected over a seven-day period in weeks 0, 1, 4, and 8 of the trial)
Total Wake Time After Sleep Onset
Mean total number of minutes awake between initial sleep onset and final morning awakening, measured by actigraphy and self-reported sleep diary. Mean wake after sleep onset will be collected over a seven-night period in weeks 0, 1, 4, and 8 of the trial.
Measured: 28 days (collected over a seven-day period in weeks 0, 1, 4, and 8 of the trial)
Change in Perceived Stress Scale 4 (PSS-4) Score
Mean daily scores on the PSS-4 (a four item scale self-reported scale than measures stress using a 0-4 Likert scale); total range of PSS-4 scores is 0-16; lower scores indicate lower daily stress relative to higher scores, which indicate higher daily stress. Mean PSS-4 scores will be collected over a seven-day period in weeks 0, 1, 4, and 8 of the trial.
Measured: 28 days (collected over a seven-day period in weeks 0, 1, 4, and 8 of the trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start20 Nov 2020
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Andrew S Huhn, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287062
- Sponsor's protocol ID
- IRB00223942
- Other IDs
- U01HL150835
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2020
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No