| Primary | 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. | | Posted | | Mean | Standard Deviation | percentage of oxygen saturation | | Baseline visit (Safety measure) | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.17± .94
- OG001-0.33± .82
|
|
| |
| Primary | 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) | | Posted | | Mean | Standard Deviation | percentage of oxygen saturation | | Week 1 visit, safety measure | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Primary | 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. | | Posted | | Mean | Standard Deviation | percentage of oxygen saturation | | Week 2 visit, safety measure | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Primary | 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. | | Posted | | Mean | Standard Deviation | mmHg (millimeters of mercury) | | Baseline Visit, safety measure | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Primary | 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. | | Posted | | Mean | Standard Deviation | mmHg (millimeters of mercury) | | Week 1 visit, safety measure | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Primary | 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. | | Posted | | Mean | Standard Deviation | mmHg (millimeters of mercury) | | Week 2 visit, safety measure | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Primary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline visit, safety measure | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | |
|
| Primary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 1 visit, safety measure | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | |
|
| Primary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 2 visit, safety measure | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Primary | 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. | | Posted | | Mean | Standard Deviation | Nanograms/milliliter (ng/mL) | | Baseline visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
| |
| Primary | 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. | | Posted | | Mean | Standard Deviation | Nanograms/milliliter (ng/mL) | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
| |
| Primary | 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. | | Posted | | Mean | Standard Deviation | Nanograms/milliliter (ng/mL) | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
| |
| Primary | 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. | Lemborexant serum levels are not provided as the detailed methods for lemborexant level determination are proprietary and we do not have access to those methods. Hence, we are not able to provide the lemborexant levels. 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. | Posted | | | | | | Baseline visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 |
|
| Primary | 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. | Lemborexant serum levels are not provided as the detailed methods for lemborexant level determination are proprietary and we do not have access to those methods. Hence, we are not able to provide the lemborexant levels. 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. | Posted | | | | | | Week 1 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 |
|
| Primary | 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. | Lemborexant serum levels are not provided as the detailed methods for lemborexant level determination are proprietary and we do not have access to those methods. Hence, we are not able to provide the lemborexant levels. 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. | Posted | | | | | | Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 |
|
| Primary | 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. | | Posted | | Mean | Standard Deviation | mmHg (millimeters of mercury) | | Baseline visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Primary | 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 | | Posted | | Mean | Standard Deviation | millimeters of mercury (mmHg) | | Week 1 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Primary | 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. | | Posted | | Mean | Standard Deviation | mmHg (millimeters of mercury) | | Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 1 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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. | During each inpatient visit from admission to discharge, up to 24 hours (Baseline through week 2) | Posted | | Mean | Standard Deviation | score on a scale | | During each inpatient visit (baseline through week 2) from admission to discharge at each visit, up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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). | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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). | | Posted | | Mean | Standard Deviation | score on a scale | | Week 1 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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). | | Posted | | Mean | Standard Deviation | score on a scale | | Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 1 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 1 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|
| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | Lemborexant Arm | 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. Lemborexant: 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). Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. | | OG001 | Placebo Arm | Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2) Placebo: 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 matches the intervention drug. Buprenorphine-naloxone: Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film. |
|