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| ID | Type | Description | Link |
|---|---|---|---|
| UG3DA048734 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo sleep medication (Placebo oral capsule) |
|
| Low Dose Suvorexant | Active Comparator | Low dose sleep medication |
|
| High Dose Suvorexant | Active Comparator | High dose sleep medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo oral capsule | Drug | Placebo Sleep Medication |
| |
| Low Dose Suvorexant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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
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
Have circumstances that would interfere with study participation (e.g., impending jail)
Self-reported male or female
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| Name | Affiliation | Role |
|---|---|---|
| Andrew S Huhn, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
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90 individuals were consented and screened (35 did not meet eligibility criteria), 55 were scheduled for admission (7 did not present for admission), 48 were admitted for buprenorphine induction (2 were found to be ineligible at this stage and another 6 left prior to randomization), 40 were randomized (1 left before receiving study drug and 1 was excluded because of uncontrolled precipitated withdrawal), and 38 were included in the analyses of study outcomes.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo sleep medication (Placebo oral capsule) Placebo oral capsule: Placebo Sleep Medication |
| FG001 | Low Dose Suvorexant | Low dose sleep medication Low Dose Suvorexant: Low Dose Suvorexant |
| FG002 | High Dose Suvorexant | High dose sleep medication High Dose Suvorexant: High Dose Suvorexant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo sleep medication (Placebo oral capsule) Placebo oral capsule: Placebo Sleep Medication |
| BG001 | Low Dose Suvorexant | Low dose sleep medication Low Dose Suvorexant: Low Dose Suvorexant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition. | Posted | Mean | Standard Deviation | score on a scale*days | 4 nights |
|
11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo sleep medication (Placebo oral capsule) Placebo oral capsule: Placebo Sleep Medication |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment | Headache |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew S. Huhn, Ph.D. | The Johns Hopkins University School of Medicine | 410-550-1971 | ahuhn1@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2019 | Jun 22, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2021 | May 13, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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| Drug |
Low Dose Suvorexant |
|
| High Dose Suvorexant | Drug | High Dose Suvorexant |
|
| Three days following buprenorphine discontinuation |
| BG002 | High Dose Suvorexant | High dose sleep medication High Dose Suvorexant: High Dose Suvorexant |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Low Dose Suvorexant |
Low dose sleep medication Low Dose Suvorexant: Low Dose Suvorexant |
| OG002 | High Dose Suvorexant | High dose sleep medication High Dose Suvorexant: High Dose Suvorexant |
|
|
|
| Primary | 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. | Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition. | Posted | Mean | Standard Deviation | minutes*nights | Four nights during a buprenorphine taper |
|
|
|
|
| Primary | 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. | Prior to completion of the post-taper phase, 4 participants dropped out from the placebo condition, 5 dropped out from the low-dose suvorexant condition, and 3 dropped out from the high-dose suvorexant condition. | Posted | Mean | Standard Deviation | minutes*nights | Four nights following buprenorphine discontinuation |
|
|
|
|
| Primary | 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). | Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition. | Posted | Mean | Standard Deviation | score on a scale*days | Three days during a buprenorphine taper |
|
|
|
|
| Primary | 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). | Prior to completion of the post-taper phase, 4 participants dropped out from the placebo condition, 5 dropped out from the low-dose suvorexant condition, and 3 dropped out from the high-dose suvorexant condition. | Posted | Mean | Standard Deviation | score on a scale*days | Three days following buprenorphine discontinuation |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 6 |
| 12 |
| EG001 | Low Dose Suvorexant | Low dose sleep medication Low Dose Suvorexant: Low Dose Suvorexant | 0 | 14 | 0 | 14 | 8 | 14 |
| EG002 | High Dose Suvorexant | High dose sleep medication High Dose Suvorexant: High Dose Suvorexant | 0 | 12 | 0 | 12 | 7 | 12 |
| EG003 | Pre-randomization | Pre-randomization to Suvorexant or placebo groups | 0 | 38 | 0 | 38 | 10 | 38 |
| Abdominal Cramp | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Distention | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| Prolonged Erection | Reproductive system and breast disorders | Systematic Assessment | Did not meet criteria for priapism |
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| Agitation | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Confusion | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dream Abnormal | Nervous system disorders | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | Systematic Assessment |
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| Euphoria | Nervous system disorders | Systematic Assessment |
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| Impaired/Groggy | Nervous system disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Appetite Decreased | General disorders | Systematic Assessment |
|
| Appetite Increased | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspensia | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulance | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain Lower Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Light headed | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Stuttering/Fluency Disorder | Nervous system disorders | Systematic Assessment |
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| Photophobia | Eye disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sweat Increased | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Itchy Eyes | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eye Pain | Eye disorders | Systematic Assessment |
|
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| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |