Opioid DependencePhase 2NCT03789214
Medical Management of Sleep Disturbance During Opioid Tapering
A Phase 2 study testing Low Dose Suvorexant and High Dose Suvorexant in people with Opioid Dependence and Opioid Withdrawal, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence, Opioid Withdrawal, Sleep Disturbance
- What is being tested?
- Low Dose Suvorexant and High Dose Suvorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 10 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years old and above
- Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for OUD with evidence of physical dependence on opioids, and seeking treatment to stop using illicit opioids.
- Provides a urine sample that tests positive for opioids.
- Willing to comply with the study protocol.
- Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation.
Who cannot join
- Seeking or currently enrolled in methadone or buprenorphine maintenance treatment for OUD
- Pregnant or breast feeding
- Have evidence of physical dependence on alcohol or benzodiazepines that requires medical detoxification
- Have a known allergy to the study medications
- Past 30-day prescribed use of suvorexant or benzodiazepines for the indication of insomnia
- Current use of a Selective Serotonin Reuptake Inhibitor (SSRI) or Monoamine oxidase (MAO) inhibitor for depression or insomnia, or other medications that are contraindicated with suvorexant
Show all 15Show fewer
- Current narcolepsy, restless leg syndrome or sleep paralysis
- High risk for current sleep apnea
- Current major depressive disorder
- Past year suicidal behavior
- Severe hepatic or renal impairment
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3x ULN
- Total bilirubin >2x Upper Limit of Normal (ULN)
- Creatinine >1.5x ULN
- Have circumstances that would interfere with study participation (e.g., impending jail)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine for three days before being randomly assigned to study condition. All participants will then undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase. Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO and the investigators hypothesize that one or both doses of SUVO will improve total sleep time relative to placebo. Patients will attend a single follow-up session, 5-10 days following discharge.
- Conditions
- Opioid Dependence, Opioid Withdrawal, Sleep Disturbance
- Being tested
- Placebo oral capsule, Low Dose Suvorexant, High Dose Suvorexant
- Medical subject headings
- Opioid-Related Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral capsuleDrug
Placebo Sleep Medication
Low Dose SuvorexantDrug
Low Dose Suvorexant
High Dose SuvorexantDrug
High Dose Suvorexant
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo sleep medication (Placebo oral capsule) Receives: Drug: Placebo oral capsule |
| Low Dose Suvorexant | Active comparator | Low dose sleep medication Receives: Drug: Low Dose Suvorexant |
| High Dose Suvorexant | Active comparator | High dose sleep medication Receives: Drug: High Dose Suvorexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abuse Liability as Assessed by Visual Analogue Scale
Area-under-the-curve of self-reported feelings of drug "High" on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question "Last night, did you feel HIGH?". A score of "0" indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.
Measured: 4 nights
Total Sleep Time During Buprenorphine Taper
Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
Measured: Four nights during a buprenorphine taper
Total Sleep Time During Post-taper
Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
Measured: Four nights following buprenorphine discontinuation
Subjective Opiate Withdrawal Scale During Buprenorphine Taper
Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
Measured: Three days during a buprenorphine taper
Subjective Opiate Withdrawal Scale During Post-taper
Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
Measured: Three days following buprenorphine discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Jul 2019
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
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 Opioid DependenceStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Andrew S Huhn, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789214
- Sponsor's protocol ID
- IRB00198426
- Other IDs
- UG3DA048734
- Status last verified
- Jul 2022
- First submitted
- 26 Dec 2018
- Last updated
- 8 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Management of Sleep Disturbance During Opioid Tapering
- ClinicalTrials.gov ID
- NCT03789214
- Acronym / sponsor ID
- IRB00198426
- Conditions
- Opioid Dependence, Opioid Withdrawal, Sleep Disturbance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Posted 8 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine for three days before being randomly assigned to study condition. All participants will then undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase. Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO and the investigators hypothesize that one or both doses of SUVO will improve total sleep time relative to placebo. Patients will attend a single follow-up session, 5-10 days following discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo sleep medication (Placebo oral capsule) |
| Low Dose Suvorexant | Active comparator | Drug: Low Dose SuvorexantLow dose sleep medication |
| High Dose Suvorexant | Active comparator | Drug: High Dose SuvorexantHigh dose sleep medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years old and above
- Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for OUD with evidence of physical dependence on opioids, and seeking treatment to stop using illicit opioids.
- Provides a urine sample that tests positive for opioids.
- Willing to comply with the study protocol.
- Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation.
Key exclusion criteria (15 listed)
- Seeking or currently enrolled in methadone or buprenorphine maintenance treatment for OUD
- Pregnant or breast feeding
- Have evidence of physical dependence on alcohol or benzodiazepines that requires medical detoxification
- Have a known allergy to the study medications
- Past 30-day prescribed use of suvorexant or benzodiazepines for the indication of insomnia
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 |
|---|---|---|
| Placebo oral capsulePlacebo Sleep Medication | Drug | Placebo |
| Low Dose SuvorexantLow Dose Suvorexant | Drug | Low Dose Suvorexant |
| High Dose SuvorexantHigh Dose Suvorexant | Drug | High Dose Suvorexant |
Primary outcome
Abuse Liability as Assessed by Visual Analogue Scale
Time frame: 4 nights
Area-under-the-curve of self-reported feelings of drug "High" on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question "Last night, did you feel HIGH?". A score of "0" indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.
Total Sleep Time During Buprenorphine Taper
Time frame: Four nights during a buprenorphine taper
Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
Total Sleep Time During Post-taper
Time frame: Four nights following buprenorphine discontinuation
Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
Subjective Opiate Withdrawal Scale During Buprenorphine Taper
Time frame: Three days during a buprenorphine taper
Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
Subjective Opiate Withdrawal Scale During Post-taper
Time frame: Three days following buprenorphine discontinuation
Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andrew S Huhn, PhD principal investigator
Johns Hopkins 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 Low Dose Suvorexant and High Dose Suvorexant in people with Opioid Dependence and Opioid Withdrawal, run by Johns Hopkins 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 5 inclusion and 15 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: finished, as of the sponsor's last update on 8 Aug 2022. 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?
Yes. Results are posted in the registry (first posted 8 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Abuse Liability as Assessed by Visual Analogue Scale (time frame: 4 nights). The study lists 5 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 8 Aug 2022.