Opioid-use DisorderPhase 2NCT04262193
Dual-Orexin Antagonism As a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder
A Phase 2 study testing Suvorexant in people with Opioid-use Disorder and Sleep, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Opioid-use Disorder, Sleep
- 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
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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])
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Study Design. Using a placebo-controlled, parallel-group, randomized clinical trial design, we will prospectively evaluate whether nightly treatment with the orexin-1/2 receptor antagonist suvorexant (20 mg/day PO), relative to placebo, can increase outpatient opioid abstinence and improve sleep efficiency (sleep time per time-in-bed) as a mediator/moderator among patients with OUD. We include current medication for treating OUD, as well as treatment site, as stratification factors in the group allocation. Using power and sample size calculations, we estimate that 120 participants will suffice to test our hypotheses.
The study aims to test three co-primary hypotheses:
Hypothesis 1: Relative to placebo, suvorexant (20 mg/day) will significantly increase percentage opioid abstinence during outpatient weeks 1-13.
Hypothesis 2: Relative to placebo, suvorexant will improve sleep efficiency.
Hypothesis 3: Higher inpatient sleep efficiency will be associated with increased outpatient opioid abstinence (independent of experimental group assignment).
- Conditions
- Opioid-use Disorder, Sleep
- Being tested
- Suvorexant, Suvorexant Placebo
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuvorexantDrug
Also called Belsomra
In each group, the participant will take 1 tablet (placebo or 20mg) 30 minutes before bedtime.
Suvorexant PlaceboDrug
Suvorexant Placebo
| Study group | Role | What they receive |
|---|---|---|
| Suvorexant placebo | Placebo comparator | Placebo (inert) tablet Receives: Drug: Suvorexant Placebo |
| Suvorexant 20mg | Experimental | Suvorexant 20mg tablet Receives: Drug: Suvorexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid abstinence
Percentage of opioid-free urine drug screens (UDS)
Measured: up to 13 weeks
Sleep efficiency
Sleep efficiency equals sleep time (determined by standardized scoring of electroencephalogram recordings) divided by time in bed
Measured: Sleep efficiency is measured on the evening of the first medication dose
Secondary outcomes (9)
Daily sleep questionnaire
Morning (post-awakening) assessment of sleep quality
Measured: Change in sleep quality scores from inpatient stay to outpatient weeks 2, 6 and 10
Actigraphic assessment of sleep
Actigraphic assessment of motion (activity counts), measured with Actiwatch and scoring software; motion is absent during sleep.
Measured: Change in total activity counts across outpatient weeks 2, 6 and 10
Weekly sleep questionnaire
Retrospective (past-week) self-report of sleep quality on each of 4 outpatient weeks
Measured: Change in sleep quality scores across outpatient weeks 1, 4, 8 and 12
Timeline followback interview assessment of substance use
Percentage of outpatient weeks with substance use (opioids, methadone, buprenorphine, cocaine metabolites, benzodiazepines, barbiturates, cannabinoids, amphetamines)
Measured: Once weekly (in conjunction with urine drug screen) on outpatient weeks 1 through 13
Urinary cortisol
Change in cortisol levels in picogram per milliliter (pg/ml) across 24 hour interval used to measure circadian rhythm
Measured: 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
Urinary melatonin
Change in melatonin levels in picograms per milliliter (pg/ml) across 24 hour interval used to measure circadian rhythm
Measured: Measured at 11pm on nights 4, 6, 8 (coordinated with sleep efficiency and cortisol assessments) and the following day (7am and 3pm on days 5, 7, 9) on the inpatient unit
Clinical Global Impression (CGI)
CGI subscale scores for improvement and severity. Each subscale is scored on a 1-7 scale. Higher scores indicate worse (more severe) outcomes.
Measured: Change in CGI subscale scores across outpatient weeks 4, 8, and 12
Short Form-36 v2 Health Survey
Overall health assessment. The 36 items are grouped into 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. Each scale is directly transformed into a 0-100 scale. Lower scores on each scale indicate greater disability.
Measured: Change in overall health total score across outpatient weeks 4, 8, and 12
Medication satisfaction
Assessment of satisfaction with assigned medication condition, on 1-7 Likert scale. Higher scores indicate greater medication satisfaction.
Measured: Change in medication satisfaction score across outpatient weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Feb 2021
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Why it stopped: Did not meet enrollment goals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of the 2 parallel groups for the duration of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Health System, Ascension Brighton Center for Recovery
- Responsible party
- Principal investigator, Mark Greenwald, PhD, Wayne State University
- Investigators
- Mark K Greenwald, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262193
- Sponsor's protocol ID
- DORA, Sleep and Opioid Use
- Status last verified
- Sep 2024
- First submitted
- 6 Feb 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This plan is under development. This project was funded under the NIH HEAL Initiative, which requires data sharing through a repository; IPD details are being determined.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Orexin Antagonism As a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04262193
- Acronym / sponsor ID
- DORA, Sleep and Opioid Use
- Conditions
- Opioid-use Disorder, Sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not meet enrollment goals.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Henry Ford Health System, Ascension Brighton Center for Recovery
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design. Using a placebo-controlled, parallel-group, randomized clinical trial design, we will prospectively evaluate whether nightly treatment with the orexin-1/2 receptor antagonist suvorexant (20 mg/day PO), relative to placebo, can increase outpatient opioid abstinence and improve sleep efficiency (sleep time per time-in-bed) as a mediator/moderator among patients with OUD. We include current medication for treating OUD, as well as treatment site, as stratification factors in the group allocation. Using power and sample size calculations, we estimate that 120 participants will suffice to test our hypotheses.
The study aims to test three co-primary hypotheses:
Hypothesis 1: Relative to placebo, suvorexant (20 mg/day) will significantly increase percentage opioid abstinence during outpatient weeks 1-13.
Hypothesis 2: Relative to placebo, suvorexant will improve sleep efficiency.
Hypothesis 3: Higher inpatient sleep efficiency will be associated with increased outpatient opioid abstinence (independent of experimental group assignment).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of the 2 parallel groups for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Suvorexant placebo | Placebo comparator | Drug: Suvorexant PlaceboPlacebo (inert) tablet |
| Suvorexant 20mg | Experimental | Drug: SuvorexantSuvorexant 20mg tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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])
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuvorexantAlso: BelsomraIn each group, the participant will take 1 tablet (placebo or 20mg) 30 minutes before bedtime. | Drug | Suvorexant 20mg |
| Suvorexant PlaceboSuvorexant Placebo | Drug | Suvorexant placebo |
Primary outcome
Opioid abstinence
Time frame: up to 13 weeks
Percentage of opioid-free urine drug screens (UDS)
Sleep efficiency
Time frame: Sleep efficiency is measured on the evening of the first medication dose
Sleep efficiency equals sleep time (determined by standardized scoring of electroencephalogram recordings) divided by time in bed
9 secondary outcomes
Daily sleep questionnaire
Time frame: Change in sleep quality scores from inpatient stay to outpatient weeks 2, 6 and 10
Actigraphic assessment of sleep
Time frame: Change in total activity counts across outpatient weeks 2, 6 and 10
Weekly sleep questionnaire
Time frame: Change in sleep quality scores across outpatient weeks 1, 4, 8 and 12
Timeline followback interview assessment of substance use
Time frame: Once weekly (in conjunction with urine drug screen) on outpatient weeks 1 through 13
Urinary cortisol
Time frame: 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
Urinary melatonin
Time frame: Measured at 11pm on nights 4, 6, 8 (coordinated with sleep efficiency and cortisol assessments) and the following day (7am and 3pm on days 5, 7, 9) on the inpatient unit
Clinical Global Impression (CGI)
Time frame: Change in CGI subscale scores across outpatient weeks 4, 8, and 12
Short Form-36 v2 Health Survey
Time frame: Change in overall health total score across outpatient weeks 4, 8, and 12
Medication satisfaction
Time frame: Change in medication satisfaction score across outpatient weeks 4, 8, and 12
Results and safety
The study was stopped early (reason given: Did not meet enrollment goals.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: Yes. This plan is under development. This project was funded under the NIH HEAL Initiative, which requires data sharing through a repository; IPD details are being determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark K Greenwald, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suvorexant in people with Opioid-use Disorder and Sleep, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Did not meet enrollment goals.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid abstinence (time frame: up to 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.