Drug InteractionPhase 1/2NCT04818086
Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
A Phase 1/2 study testing Lemborexant and Buprenorphine-naloxone in people with Drug Interaction and Analgesics, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to test the safety, tolerability, drug interactions with buprenorphine-naloxone, and effectiveness lemborexant when used to treat Opioid Use Disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug Interaction, Analgesics, Opioid Use Disorder
- What is being tested?
- Lemborexant and Buprenorphine-naloxone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 20 Apr 2023
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 18 - 65 years-of-age;
- Understand the study procedures and provide written informed consent in English language;
- Meet current DSM-5 criteria for opioid use disorder, of at least moderate severity, currently engaged medication assisted treatment at a buprenorphine-naloxone sublingual film daily dose ranging from 8mg/2mg to 24mg/6mg or buprenorphine sublingual tablet 5.7mg/1.4mg to 17.1/4.3 once daily for at least last 2 weeks;
- Have a positive urine drug screen for buprenorphine during screening and on admission to the clinical research unit to document buprenorphine use;
- Have a Pittsburgh Sleep Quality Index (PSQI) Total Score of 6 or higher.
Who cannot join
- Contraindications for participation as determined by medical history and physical exam performed by study NP or study physician;
- Pregnant or nursing women;
- Baseline ECG with clinically significant abnormal conduction;
- Uncontrolled serious psychiatric or major medical disorder, including COPD. Narcolepsy is also considered exclusionary;
- Taking prescription or over-the counter drugs or dietary supplements known to significantly inhibit CYP3A4 (such as Clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir), or CYP3A4 inducers (such as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids);
- Prescribed medications for insomnia, or unable to discontinue over the counter drugs or dietary supplements used to treat insomnia on study days.
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- Current severe alcohol use disorder or current benzodiazepine use disorder
- Current DSM-5 diagnosis of any psychoactive substance use disorder other than opioids, cocaine, marijuana, or nicotine, or mild or moderate alcohol use disorder. Diagnosis of mild to moderate use disorder for alcohol will not be considered exclusionary.
- Any previous medically adverse reaction to opioids or lemborexant:
- Significant current suicidal or homicidal ideation (C-SSRS "yes" answers on questions 4 or 5) or a history of suicide attempt within the past 6 months.
- Subjects with Suicidal Behaviors Questionnaire-Revised score ≥8 at the screening visit.
- Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Phase Ib/2a Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
The purpose of this research study is to test the safety, tolerability, drug interactions with buprenorphine-naloxone, and effectiveness lemborexant when used to treat Opioid Use Disorder.
Read the detailed description
The purpose of this study is to test the effects of lemborexant when used in combination with opioids (including buprenorphine). We are also interested in learning lemborexant might help improve sleep problems and problems related to opioid use (e.g., cravings, withdrawal), in people with opioid use disorder. Study participants will be randomly assigned in a two to one ratio to receive either lemborexant or placebo. Lemborexant (DAYVIGO®) is approved by the U. S. Food and Drug Administration (FDA) for treatment of insomnia.
In this study, Participants will be asked to do the following things:
- Visit the CARI clinic and/or Motivate clinic at Jackson Center to complete study screening.
- Visit the VCUHS Clinical Research Unit to complete an outpatient blood draw/testing visit.
- Take either lemborexant or the placebo, depending upon which group subjects are assigned to.
- Complete two (2) overnight study visits at the VCUHS Clinical Research Unit.
- Complete 8 outpatient follow-up visits (broken into 2 four day visit groupings)
- Have an EKG during screening and at each study visit (outpatient and inpatient)
- Have an IV inserted into your arm for blood draws at the outpatient blood draw visit and each inpatient visit.
- Record sleep in a sleep diary.
- Take surveys and answer questions about health, mental health, medications used, drug use, and cravings.
- Complete tasks on the computer.
- Complete physical exams during screening, outpatient and inpatient visits.
- Give permission for the researchers to collect information about opioid treatment, medical status, and other information from your medical record.
Participation in this study will last approximately 4 weeks. Approximately 18 people will participate in the drug interaction phase of this study.
- Conditions
- Drug Interaction, Analgesics, Opioid Use Disorder
- Being tested
- Lemborexant, Placebo, Buprenorphine-naloxone
- 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.
LemborexantDrug
Also called Dayvigo
Participants will complete 2 inpatient visits which may last up to 24 hours. The two visits will be approximately 14 days apart. During the inpatient visit they will receive 5 mg of lemborexant (first visit) and 10 mg of lemborexant (second visit).
PlaceboDrug
Participants will complete 2 inpatient visits which may last up to 24 hours. The two visits will be approximately 14 days apart. During the inpatient visit they will receive a placebo which is encapsulated to look the same as the intervention drug.
Buprenorphine-naloxoneDrug
Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.
| Study group | Role | What they receive |
|---|---|---|
| Lemborexant Arm | Active comparator | Study Drug Dosage: 5 mg of lemborexant (Time 1) , and 10 mg of lemborexant (Time 2) combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. Receives: Drug: Lemborexant; Drug: Buprenorphine-naloxone |
| Placebo Arm | Placebo comparator | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Receives: Drug: Placebo; Drug: Buprenorphine-naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulse Oximetry During the Baseline Visit
A finger pulse oximeter will be used to assess oxygen saturation (%). Change is calculated from the pulse oximetry readings from pre to post medication/placebo dose administered during the baseline study visit, this is a safety measure.
Measured: Baseline visit (Safety measure)
Change in Pulse Oximetry During Week 1 Visit
A finger pulse oximeter will be used to asses pulse oximetry. Change is calculated from the pulse oximetry readings from pre to post medication/placebo dose administered during the study visit (safety measure)
Measured: Week 1 visit, safety measure
Change in Pulse Oximetry During Week 2 Visit
A finger pulse oximeter will be used to assess pulse oximetry. Change is calculated from the pulse oximetry readings from pre to post medication/placebo dose administered during the study visit. This is a safety measure.
Measured: Week 2 visit, safety measure
Change in Blood Pressure During Baseline Study Visit
Blood Pressure measured with an automatic BP cuff. Change is calculated from the blood pressure readings from pre to post medication/placebo dose administered during the study visit. This is a safety measure.
Measured: Baseline Visit, safety measure
Change in Blood Pressure During Week 1 Study Visit
Blood Pressure measured with an automatic BP cuff. Change is calculated from the blood pressure readings from pre to post medication/placebo dose administered during the study visit. This is a safety measure.
Measured: Week 1 visit, safety measure
Change in Blood Pressure During Week 2 Study Visit
Blood Pressure measured with an automatic BP cuff. Change is calculated from the blood pressure readings from pre to post medication/placebo dose administered during the study visit. This is a safety measure.
Measured: Week 2 visit, safety measure
Change in Patient Consciousness During the Baseline Visit
The Richmond Agitation Sedation Scale (RASS) measures level of patient consciousness on a 10 point scale ranging from plus +4 (combative/agitated) to minus 5 (unarousable/sedated). Change is calculated from the RASS assessment scores obtained from pre to post medication/placebo dose administered during the study visit. This is a safety measure. RASS is one of the most commonly used scales to determine the sedation level, and it measures the severity of agitation and sedation with a score of +4 to -5: +4: combative, +3: very agitated, +2: agitated, +1: restless, 0: alert and calm, -1: drowsy, -2: light sedation, -3: moderate sedation, -4: deep sedation, and -5 unarousable. A positive score is preferable to a negative score.
Measured: Baseline visit, safety measure
Change in Patient Consciousness During the Week 1 Study Visit
The Richmond Agitation Sedation Scale (RASS) measures level of patient consciousness on a 10 point scale ranging from plus 4 (combative/agitated) to minus 5 (unarousable/sedated).Change is calculated from the RASS assessment scores obtained from pre to post medication/placebo dose administered during the study visit. This is a safety measure. RASS is one of the most commonly used scales to determine the sedation level, and it measures the severity of agitation and sedation with a score of +4 to -5: +4: combative, +3: very agitated, +2: agitated, +1: restless, 0: alert and calm, -1: drowsy, -2: light sedation, -3: moderate sedation, -4: deep sedation, and -5 unarousable. A positive score is preferable to a negative score.
Measured: Week 1 visit, safety measure
Change in Patient Consciousness
The Richmond Agitation Sedation Scale (RASS) measures level of patient consciousness on a 10 point scale ranging from plus 4 (combative/agitated) to minus 5 (unarousable/sedated). Change is calculated from the RASS assessment scores obtained from pre to post medication/placebo dose administered during the study visit. This is a safety measure. RASS is one of the most commonly used scales to determine the sedation level, and it measures the severity of agitation and sedation with a score of +4 to -5: +4: combative, +3: very agitated, +2: agitated, +1: restless, 0: alert and calm, -1: drowsy, -2: light sedation, -3: moderate sedation, -4: deep sedation, and -5 unarousable. A positive score is preferable to a negative score.
Measured: Week 2 visit, safety measure
Change in Buprenorphine Plasma Concentration (PK) During the Baseline Visit
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the area under the plasma concentration-time curve for buprenorphine.
Measured: Baseline visit
Change in Buprenorphine Plasma Concentration (PK) During Week 1 Study Visit
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the area under the plasma concentration-time curve for buprenorphine.
Measured: Week 1
Change in Buprenorphine Plasma Concentration (PK) During Week 2 Study Visit
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the area under the plasma concentration-time curve for buprenorphine.
Measured: Week 2
Change in Lemborexant PK During Baseline Study Visit
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the peak plasma concentration for Lemborexant.
Currently, we have no pathway to obtain the lorcaserin PK results. The reason for that is the methods used for the original lorcaserin human PK testing are proprietary and we would have to re-do all of that research ourselves, which is outside the scope of what we are able to do.
Measured: Baseline visit
Change in Lemborexant PK During Week 1 Study Visit
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the area under the plasma concentration-time curve for Lemborexant. Currently, we have no pathway to obtain the lorcaserin PK results. The reason for that is the methods used for the original lorcaserin human PK testing are proprietary and we would have to re-do all of that research ourselves, which is outside the scope of what we are able to do.
Measured: Week 1 visit
Change in Lemborexant PK During Week 2 Study Visit
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the peak plasma concentration for Lemborexant. Currently, we have no pathway to obtain the lorcaserin PK results. The reason for that is the methods used for the original lorcaserin human PK testing are proprietary and we would have to re-do all of that research ourselves, which is outside the scope of what we are able to do.
Measured: Week 2 visit
Change in Respiration During the Baseline Study Visit (Pre- to Post-dose)
Respiration will be measured with End Title CO2( EtC02) which is a measure of CO2 (measured in millimeters of mercury, "mmHg") plotted against time. Participants will wear a mask which will be connected to a Capnographer. End Title CO2 should be between 35-45 mmHg with box wave form.
Measured: Baseline visit
Change in Respiration During the Week 1 Study Visit (Pre- to Post-dose)
Respiration will be measured with End Title CO2( EtC02) which is a measure of CO2 (measured in millimeters of mercury, "mmHg") plotted against time. Participants will wear a mask which will be connected to a Capnographer. End Title CO2 should be between 35-45 mmHg with box wave form
Measured: Week 1 visit
Change in Respiration During Week 2 Study Visit (From Pre- to Post-dose)
Respiration will be measured with End Title CO2( EtC02) which is a measure of CO2 (measured in millimeters of mercury, "mmHg") plotted against time. Participants will wear a mask which will be connected to a Capnographer. End Title CO2 should be between 35-45 mmHg with box wave form.
Measured: Week 2 visit
Secondary outcomes (13)
Change in Drug Effects During Baseline Study Visit (Pre- to Post- Dose)
Drug effects will be assessed using the Drug Effects Questionnaire (DEQ). The DEQ is comprised of 11 items which assess physical effects of the drug. Participants rate each physical effect on a visual analog scale from "not at all" (0) to "extremely" (100). A higher score indicates greater drug effect. The Drug Effects Questionnaire (DEQ) is widely used in studies of acute subjective response (SR) to a variety of substances and assesses the extent to which participants (1) feel any substance effect(s), (2) feel high, (3) like the effects, (4) dislike the effects, and (5) want more of the substance using 100mm Visual Analog Scales.
Measured: Baseline visit
Change in Drug Effects During Week 1 Study Visit (Pre- to Post- Dose)
Drug effects will be assessed using the Drug Effects Questionnaire (DEQ). The DEQ is comprised of 11 items which assess physical effects of the drug. Participants rate each physical effect on a visual analog scale from "not at all" (0) to "extremely" (100). A higher score indicates greater drug effect. The Drug Effects Questionnaire (DEQ) is widely used in studies of acute subjective response (SR) to a variety of substances and assesses the extent to which participants (1) feel any substance effect(s), (2) feel high, (3) like the effects, (4) dislike the effects, and (5) want more of the substance using 100mm Visual Analog Scales.
Measured: Week 1 visit
Change in Drug Effects During Week 2 Study Visit (Pre- to Post Dose)
Drug effects will be assessed using the Drug Effects Questionnaire (DEQ). The DEQ is comprised of 11 items which assess physical effects of the drug. Participants rate each physical effect on a visual analog scale from "not at all" (0) to "extremely" (100). A higher score indicates greater drug effect. The Drug Effects Questionnaire (DEQ) is widely used in studies of acute subjective response (SR) to a variety of substances and assesses the extent to which participants (1) feel any substance effect(s), (2) feel high, (3) like the effects, (4) dislike the effects, and (5) want more of the substance using 100mm Visual Analog Scales.
Measured: Week 2 visit
Change in Opioid Craving During Each Visit (Pre- to Post- Dose)
Opioid craving will be measured by a Brief Substance craving scale (BSCS). The BSCS is a 16 item, self-report instrument assesses craving for substances of abuse over a 24 hour period. Intensity and frequency of craving are recorded on a five-point Likert scale, with higher scores indicating greater craving. 0-none at all, 1- slight, 2-moderate, 3-considerable, 4-extreme.
Measured: During each inpatient visit (baseline through week 2) from admission to discharge at each visit, up to 24 hours
Change in Opioid Withdrawal Effects During Baseline Visit (Pre- to Post- Dose)
Opioid withdrawal symptoms will be measured with the Subjective Opioid Withdrawal Scale (SOWS). The SOWS contains 16 likert scaled items with participant rate from 0 (not at all), 1(slight), 2 (moderate), 3 (considerable) to 4 (Extreme). A higher score indicates higher opioid withdrawal effects (Range 0-64).
Measured: Baseline visit
Change in Opioid Withdrawal Effects During Week 1 Visit (Pre- to Post- Dose)
Opioid withdrawal symptoms will be measured with the Subjective Opioid Withdrawal Scale (SOWS). The SOWS contains 16 likert scaled items with participant rate from 0 (not at all), 1(slight), 2 (moderate), 3 (considerable) to 4 (Extremely). A higher score indicates higher opioid withdrawal effects(Range 0-64).
Measured: Week 1 visit
Change in Opioid Withdrawal Effects During Week 2 Visit (Pre- to Post- Dose)
Opioid withdrawal symptoms will be measured with the Subjective Opioid Withdrawal Scale (SOWS). The SOWS contains 16 likert scaled items with participant rate from 0 (not at all), 1(slight), 2 (moderate), 3 (considerable) to 4 (Extremely). A higher score indicates higher opioid withdrawal effects (Range 0-64).
Measured: Week 2 visit
Change in Objective Opioid Withdrawal During Baseline Study Visit (Pre- to Post- Dose)
Participants will be assessed by research staff using the Clinical Opioid Withdrawal Scale (COWS) which consists of 11 items. A higher score indicates greater withdrawal effects. (COWS, range 0-48). 5-12=mild, 13-24=moderate, 25-36=moderate severe, and more than 36=severe withdrawal.
Measured: Baseline visit
Change in Objective Opioid Withdrawal During Week 1 Study Visit (Pre- to Post-dose)
Participants will be assessed by research staff using the Clinical Opioid Withdrawal Scale (COWS) which consists of 11 items. A higher score indicates greater withdrawal effects(COWS, range 0-48). 5-12=mild, 13-24=moderate, 25-36=moderate severe, and more than 36=severe withdrawal.
Measured: Week 1 visit
Change in Objective Opioid Withdrawal During Week 2 Study Visit (Pre- to Post- Dose)
Participants will be assessed by research staff using the Clinical Opioid Withdrawal Scale (COWS) which consists of 11 items. A higher score indicates greater withdrawal effects (COWS, range 0-48). 5-12=mild, 13-24=moderate, 25-36=moderate severe, and more than 36=severe withdrawal.
Measured: Week 2 visit
Impulsivity
Impulsivity is measured by a delayed discounting task (DDT). Participants are presented with a series of choices and will choose to receive pretend money now or after a delay. The task yields a discounting rate. Higher discounting rates indicate greater impulsivity. Delay discounting, the tendency to choose small, immediate rewards over larger, delayed rewards is robustly associated with substance use. The longer the timeframe that the subject delays the rewards, the larger the reward.
Measured: Baseline visit
Impulsivity
Impulsivity is measured by a delayed discounting task (DDT). Participants are presented with a series of choices and will choose to receive pretend money now or after a delay. The task yields a discounting rate. Higher discounting rates indicate greater impulsivity. Delay discounting, the tendency to choose small, immediate rewards over larger, delayed rewards is robustly associated with substance use. The longer the timeframe that the subject delays the rewards, the larger the reward.
Measured: Week 1 visit
Impulsivity
Impulsivity is measured by a delayed discounting task (DDT). Participants are presented with a series of choices and will choose to receive pretend money now or after a delay. The task yields a discounting rate. Higher discounting rates indicate greater impulsivity. Delay discounting, the tendency to choose small, immediate rewards over larger, delayed rewards is robustly associated with substance use. The longer the timeframe that the subject delays the rewards, the larger the reward.
Measured: Week 2 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start3 May 2021
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
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 Drug InteractionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Frederick G Moeller, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818086
- Sponsor's protocol ID
- HM20021136
- Other IDs
- UG1DA050207
- Status last verified
- Oct 2024
- First submitted
- 23 Mar 2021
- Last updated
- 13 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/2a Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04818086
- Acronym / sponsor ID
- HM20021136
- Conditions
- Drug Interaction, Analgesics, Opioid Use Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Posted 13 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the safety, tolerability, drug interactions with buprenorphine-naloxone, and effectiveness lemborexant when used to treat Opioid Use Disorder.
Detailed description
The purpose of this study is to test the effects of lemborexant when used in combination with opioids (including buprenorphine). We are also interested in learning lemborexant might help improve sleep problems and problems related to opioid use (e.g., cravings, withdrawal), in people with opioid use disorder. Study participants will be randomly assigned in a two to one ratio to receive either lemborexant or placebo. Lemborexant (DAYVIGO®) is approved by the U. S. Food and Drug Administration (FDA) for treatment of insomnia.
In this study, Participants will be asked to do the following things:
- Visit the CARI clinic and/or Motivate clinic at Jackson Center to complete study screening.
- Visit the VCUHS Clinical Research Unit to complete an outpatient blood draw/testing visit.
- Take either lemborexant or the placebo, depending upon which group subjects are assigned to.
- Complete two (2) overnight study visits at the VCUHS Clinical Research Unit.
- Complete 8 outpatient follow-up visits (broken into 2 four day visit groupings)
- Have an EKG during screening and at each study visit (outpatient and inpatient)
- Have an IV inserted into your arm for blood draws at the outpatient blood draw visit and each inpatient visit.
- Record sleep in a sleep diary.
- Take surveys and answer questions about health, mental health, medications used, drug use, and cravings.
- Complete tasks on the computer.
- Complete physical exams during screening, outpatient and inpatient visits.
- Give permission for the researchers to collect information about opioid treatment, medical status, and other information from your medical record.
Participation in this study will last approximately 4 weeks. Approximately 18 people will participate in the drug interaction phase of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lemborexant Arm | Active comparator | Drug: Lemborexant, Drug: Buprenorphine-naloxoneStudy Drug Dosage: 5 mg of lemborexant (Time 1) , and 10 mg of lemborexant (Time 2) combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
| Placebo Arm | Placebo comparator | Drug: Placebo, Drug: Buprenorphine-naloxoneComparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females between 18 - 65 years-of-age;
- Understand the study procedures and provide written informed consent in English language;
- Meet current DSM-5 criteria for opioid use disorder, of at least moderate severity, currently engaged medication assisted treatment at a buprenorphine-naloxone sublingual film daily dose ranging from 8mg/2mg to 24mg/6mg or buprenorphine sublingual tablet 5.7mg/1.4mg to 17.1/4.3 once daily for at least last 2 weeks;
- Have a positive urine drug screen for buprenorphine during screening and on admission to the clinical research unit to document buprenorphine use;
- Have a Pittsburgh Sleep Quality Index (PSQI) Total Score of 6 or higher.
Key exclusion criteria (12 listed)
- Contraindications for participation as determined by medical history and physical exam performed by study NP or study physician;
- Pregnant or nursing women;
- Baseline ECG with clinically significant abnormal conduction;
- Uncontrolled serious psychiatric or major medical disorder, including COPD. Narcolepsy is also considered exclusionary;
- Taking prescription or over-the counter drugs or dietary supplements known to significantly inhibit CYP3A4 (such as Clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir), or CYP3A4 inducers (such as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids);
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 |
|---|---|---|
| LemborexantAlso: DayvigoParticipants will complete 2 inpatient visits which may last up to 24 hours. The two visits will be approximately 14 days apart. During the inpatient visit they will receive 5 mg of lemborexant (first visit) and 10 mg of lemborexant (second visit). | Drug | Lemborexant Arm |
| PlaceboParticipants will complete 2 inpatient visits which may last up to 24 hours. The two visits will be approximately 14 days apart. During the inpatient visit they will receive a placebo which is encapsulated to look the same as the intervention drug. | Drug | Placebo Arm |
| Buprenorphine-naloxoneParticipants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | Drug | Lemborexant Arm, Placebo Arm |
Primary outcome
Change in Pulse Oximetry During the Baseline Visit
Time frame: Baseline visit (Safety measure)
A finger pulse oximeter will be used to assess oxygen saturation (%). Change is calculated from the pulse oximetry readings from pre to post medication/placebo dose administered during the baseline study visit, this is a safety measure.
Change in Pulse Oximetry During Week 1 Visit
Time frame: Week 1 visit, safety measure
A finger pulse oximeter will be used to asses pulse oximetry. Change is calculated from the pulse oximetry readings from pre to post medication/placebo dose administered during the study visit (safety measure)
Change in Pulse Oximetry During Week 2 Visit
Time frame: Week 2 visit, safety measure
A finger pulse oximeter will be used to assess pulse oximetry. Change is calculated from the pulse oximetry readings from pre to post medication/placebo dose administered during the study visit. This is a safety measure.
Change in Blood Pressure During Baseline Study Visit
Time frame: Baseline Visit, safety measure
Blood Pressure measured with an automatic BP cuff. Change is calculated from the blood pressure readings from pre to post medication/placebo dose administered during the study visit. This is a safety measure.
Change in Blood Pressure During Week 1 Study Visit
Time frame: Week 1 visit, safety measure
Blood Pressure measured with an automatic BP cuff. Change is calculated from the blood pressure readings from pre to post medication/placebo dose administered during the study visit. This is a safety measure.
Change in Blood Pressure During Week 2 Study Visit
Time frame: Week 2 visit, safety measure
Blood Pressure measured with an automatic BP cuff. Change is calculated from the blood pressure readings from pre to post medication/placebo dose administered during the study visit. This is a safety measure.
Change in Patient Consciousness During the Baseline Visit
Time frame: Baseline visit, safety measure
The Richmond Agitation Sedation Scale (RASS) measures level of patient consciousness on a 10 point scale ranging from plus +4 (combative/agitated) to minus 5 (unarousable/sedated). Change is calculated from the RASS assessment scores obtained from pre to post medication/placebo dose administered during the study visit. This is a safety measure. RASS is one of the most commonly used scales to determine the sedation level, and it measures the severity of agitation and sedation with a score of +4 to -5: +4: combative, +3: very agitated, +2: agitated, +1: restless, 0: alert and calm, -1: drowsy, -2: light sedation, -3: moderate sedation, -4: deep sedation, and -5 unarousable. A positive score is preferable to a negative score.
Change in Patient Consciousness During the Week 1 Study Visit
Time frame: Week 1 visit, safety measure
The Richmond Agitation Sedation Scale (RASS) measures level of patient consciousness on a 10 point scale ranging from plus 4 (combative/agitated) to minus 5 (unarousable/sedated).Change is calculated from the RASS assessment scores obtained from pre to post medication/placebo dose administered during the study visit. This is a safety measure. RASS is one of the most commonly used scales to determine the sedation level, and it measures the severity of agitation and sedation with a score of +4 to -5: +4: combative, +3: very agitated, +2: agitated, +1: restless, 0: alert and calm, -1: drowsy, -2: light sedation, -3: moderate sedation, -4: deep sedation, and -5 unarousable. A positive score is preferable to a negative score.
Change in Patient Consciousness
Time frame: Week 2 visit, safety measure
The Richmond Agitation Sedation Scale (RASS) measures level of patient consciousness on a 10 point scale ranging from plus 4 (combative/agitated) to minus 5 (unarousable/sedated). Change is calculated from the RASS assessment scores obtained from pre to post medication/placebo dose administered during the study visit. This is a safety measure. RASS is one of the most commonly used scales to determine the sedation level, and it measures the severity of agitation and sedation with a score of +4 to -5: +4: combative, +3: very agitated, +2: agitated, +1: restless, 0: alert and calm, -1: drowsy, -2: light sedation, -3: moderate sedation, -4: deep sedation, and -5 unarousable. A positive score is preferable to a negative score.
Change in Buprenorphine Plasma Concentration (PK) During the Baseline Visit
Time frame: Baseline visit
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the area under the plasma concentration-time curve for buprenorphine.
Change in Buprenorphine Plasma Concentration (PK) During Week 1 Study Visit
Time frame: Week 1
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the area under the plasma concentration-time curve for buprenorphine.
Change in Buprenorphine Plasma Concentration (PK) During Week 2 Study Visit
Time frame: Week 2
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the area under the plasma concentration-time curve for buprenorphine.
Change in Lemborexant PK During Baseline Study Visit
Time frame: Baseline visit
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the peak plasma concentration for Lemborexant. Currently, we have no pathway to obtain the lorcaserin PK results. The reason for that is the methods used for the original lorcaserin human PK testing are proprietary and we would have to re-do all of that research ourselves, which is outside the scope of what we are able to do.
Change in Lemborexant PK During Week 1 Study Visit
Time frame: Week 1 visit
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the area under the plasma concentration-time curve for Lemborexant. Currently, we have no pathway to obtain the lorcaserin PK results. The reason for that is the methods used for the original lorcaserin human PK testing are proprietary and we would have to re-do all of that research ourselves, which is outside the scope of what we are able to do.
Change in Lemborexant PK During Week 2 Study Visit
Time frame: Week 2 visit
Blood will be drawn pre-dose and at specific time points (8, 8:30, 10, 12 and 4pm) to determine the peak plasma concentration for Lemborexant. Currently, we have no pathway to obtain the lorcaserin PK results. The reason for that is the methods used for the original lorcaserin human PK testing are proprietary and we would have to re-do all of that research ourselves, which is outside the scope of what we are able to do.
Change in Respiration During the Baseline Study Visit (Pre- to Post-dose)
Time frame: Baseline visit
Respiration will be measured with End Title CO2( EtC02) which is a measure of CO2 (measured in millimeters of mercury, "mmHg") plotted against time. Participants will wear a mask which will be connected to a Capnographer. End Title CO2 should be between 35-45 mmHg with box wave form.
Change in Respiration During the Week 1 Study Visit (Pre- to Post-dose)
Time frame: Week 1 visit
Respiration will be measured with End Title CO2( EtC02) which is a measure of CO2 (measured in millimeters of mercury, "mmHg") plotted against time. Participants will wear a mask which will be connected to a Capnographer. End Title CO2 should be between 35-45 mmHg with box wave form
Change in Respiration During Week 2 Study Visit (From Pre- to Post-dose)
Time frame: Week 2 visit
Respiration will be measured with End Title CO2( EtC02) which is a measure of CO2 (measured in millimeters of mercury, "mmHg") plotted against time. Participants will wear a mask which will be connected to a Capnographer. End Title CO2 should be between 35-45 mmHg with box wave form.
13 secondary outcomes
Change in Drug Effects During Baseline Study Visit (Pre- to Post- Dose)
Time frame: Baseline visit
Change in Drug Effects During Week 1 Study Visit (Pre- to Post- Dose)
Time frame: Week 1 visit
Change in Drug Effects During Week 2 Study Visit (Pre- to Post Dose)
Time frame: Week 2 visit
Change in Opioid Craving During Each Visit (Pre- to Post- Dose)
Time frame: During each inpatient visit (baseline through week 2) from admission to discharge at each visit, up to 24 hours
Change in Opioid Withdrawal Effects During Baseline Visit (Pre- to Post- Dose)
Time frame: Baseline visit
Change in Opioid Withdrawal Effects During Week 1 Visit (Pre- to Post- Dose)
Time frame: Week 1 visit
Change in Opioid Withdrawal Effects During Week 2 Visit (Pre- to Post- Dose)
Time frame: Week 2 visit
Change in Objective Opioid Withdrawal During Baseline Study Visit (Pre- to Post- Dose)
Time frame: Baseline visit
Change in Objective Opioid Withdrawal During Week 1 Study Visit (Pre- to Post-dose)
Time frame: Week 1 visit
Change in Objective Opioid Withdrawal During Week 2 Study Visit (Pre- to Post- Dose)
Time frame: Week 2 visit
Impulsivity
Time frame: Baseline visit
Impulsivity
Time frame: Week 1 visit
Impulsivity
Time frame: Week 2 visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- 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.
Frederick G Moeller, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lemborexant and Buprenorphine-naloxone in people with Drug Interaction and Analgesics, run by Virginia Commonwealth 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 12 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 13 Nov 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 13 Nov 2024). 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?
Change in Pulse Oximetry During the Baseline Visit (time frame: Baseline visit (Safety measure)). The study lists 18 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 13 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.