Trial · NCT04818086

Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder

NCT04818086, Phase 1, Phase 2, Completed, Virginia Commonwealth University; results first posted 2024-11-13

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder. Trials, record NCT04818086. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04818086

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
NCT number: NCT04818086
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 18 participants, actual
Lead sponsor: Virginia Commonwealth University
Conditions: Drug Interaction, Analgesics, Opioid Use Disorder
Interventions: Lemborexant, Placebo, Buprenorphine-naloxone
First posted: 2021-03-26
Last updated: 2024-11-13
Results first posted: 2024-11-13

Source ClinicalTrials.gov

Registered outcomes31

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Pulse Oximetry During the Baseline Visit	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.
Primary	Change in Pulse Oximetry During Week 1 Visit	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)
Primary	Change in Pulse Oximetry During Week 2 Visit	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.
Primary	Change in Blood Pressure During Baseline Study Visit	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.
Primary	Change in Blood Pressure During Week 1 Study Visit	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.
Primary	Change in Blood Pressure During Week 2 Study Visit	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.
Primary	Change in Patient Consciousness During the Baseline Visit	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.
Primary	Change in Patient Consciousness During the Week 1 Study Visit	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.
Primary	Change in Patient Consciousness	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.
Primary	Change in Buprenorphine Plasma Concentration (PK) During the Baseline Visit	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.

1 to 10 of 31Source ClinicalTrials.gov

See all 31 registered outcomes

Outcomes31

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Pulse Oximetry During the Baseline Visit	Baseline visit (Safety measure)	Baseline	percentage of oxygen saturation	MEAN
PRIMARY	Change in Pulse Oximetry During Week 1 Visit	Week 1 visit, safety measure	Week 1	percentage of oxygen saturation	MEAN
PRIMARY	Change in Pulse Oximetry During Week 2 Visit	Week 2 visit, safety measure	Week 2	percentage of oxygen saturation	MEAN
PRIMARY	Change in Blood Pressure During Baseline Study Visit	Baseline Visit, safety measure	Baseline	mmHg (millimeters of mercury)	MEAN
PRIMARY	Change in Blood Pressure During Week 1 Study Visit	Week 1 visit, safety measure	Week 1	mmHg (millimeters of mercury)	MEAN
PRIMARY	Change in Blood Pressure During Week 2 Study Visit	Week 2 visit, safety measure	Week 2	mmHg (millimeters of mercury)	MEAN
PRIMARY	Change in Patient Consciousness During the Baseline Visit	Baseline visit, safety measure	Baseline	score on a scale	MEAN
PRIMARY	Change in Patient Consciousness During the Week 1 Study Visit	Week 1 visit, safety measure	week 1	score on a scale	MEAN
PRIMARY	Change in Patient Consciousness	Week 2 visit, safety measure	week 2	score on a scale	MEAN
PRIMARY	Change in Buprenorphine Plasma Concentration (PK) During the Baseline Visit	Baseline visit	Baseline	Nanograms/milliliter (ng/mL)	MEAN

1 to 10 of 31Source ClinicalTrials.gov

See all 31 outcomes

Results by group53

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Pulse Oximetry During the Baseline Visit	Lemborexant Arm	-0.17	Standard Deviation .94	percentage of oxygen saturation
Change in Pulse Oximetry During the Baseline Visit	Placebo Arm	-0.33	Standard Deviation .82	percentage of oxygen saturation
Change in Pulse Oximetry During Week 1 Visit	Lemborexant Arm	-0.17	Standard Deviation 1.94	percentage of oxygen saturation
Change in Pulse Oximetry During Week 1 Visit	Placebo Arm	-0.50	Standard Deviation 1.05	percentage of oxygen saturation
Change in Pulse Oximetry During Week 2 Visit	Lemborexant Arm	-0.27	Standard Deviation 1.49	percentage of oxygen saturation
Change in Pulse Oximetry During Week 2 Visit	Placebo Arm	-0.20	Standard Deviation 0.84	percentage of oxygen saturation
Change in Blood Pressure During Baseline Study Visit	Lemborexant Arm	-9.42	Standard Deviation 10.40	mmHg (millimeters of mercury)
Change in Blood Pressure During Baseline Study Visit	Placebo Arm	-2.50	Standard Deviation 12.29	mmHg (millimeters of mercury)
Change in Blood Pressure During Week 1 Study Visit	Lemborexant Arm	-6.58	Standard Deviation 6.64	mmHg (millimeters of mercury)
Change in Blood Pressure During Week 1 Study Visit	Placebo Arm	-4.50	Standard Deviation 5.68	mmHg (millimeters of mercury)

1 to 10 of 53Source ClinicalTrials.gov

See all 53 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lemborexant Arm	12
Overall Study	STARTED	Placebo Arm	6
Overall Study	COMPLETED	Lemborexant Arm	11
Overall Study	COMPLETED	Placebo Arm	5
Overall Study	NOT COMPLETED	Lemborexant Arm	1
Overall Study	NOT COMPLETED	Placebo Arm	1

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Assaulted	Injury, poisoning and procedural complications	Lemborexant Arm	0	12	0
other	Assaulted	Injury, poisoning and procedural complications	Placebo Arm	1	6	1
other	tongue numbness	Nervous system disorders	Lemborexant Arm	0	12	0
other	tongue numbness	Nervous system disorders	Placebo Arm	1	6	1
other	Nausea/vomiting/diarrhea	Gastrointestinal disorders	Lemborexant Arm	1	12	1
other	Nausea/vomiting/diarrhea	Gastrointestinal disorders	Placebo Arm	0	6	0
other	Sweating	Skin and subcutaneous tissue disorders	Lemborexant Arm	1	12	1
other	Sweating	Skin and subcutaneous tissue disorders	Placebo Arm	0	6	0
other	Anxiety	Psychiatric disorders	Lemborexant Arm	1	12	1
other	Anxiety	Psychiatric disorders	Placebo Arm	0	6	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lemborexant Arm	0	12
Total, all-cause mortality	Placebo Arm	0	6
Total, other adverse events	Lemborexant Arm	6	12
Total, other adverse events	Placebo Arm	4	6
Total, serious adverse events	Lemborexant Arm	0	12
Total, serious adverse events	Placebo Arm	0	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UG1DA050207	Laboratories for Early Clinical Evaluation of Pharmacotherapies for Substance Use Disorders	MOELLER, FREDERICK GERARD; ARIAS, ALBERT JOSEPH	VIRGINIA COMMONWEALTH UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2020 to 2024

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lemborexant Arm vs Placebo Arm: deaths from any cause	Trial comparisons
Lemborexant Arm vs Placebo Arm: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Delay Discounting	Secondary outcome

Source ConductCognition

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04818086

GET https://conductscience.org/api/trials/v1/NCT04818086/registered?page=2

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