| Primary | Treatment Success Rate | The primary objective was to determine whether the combination of sublingual buprenorphine/naloxone (SL BUP/NAL) and OXD01 was superior to SL BUP/NAL alone to reduce opioid use, measured by the treatment success rate. Treatment success was defined as the subject having >/=80% of urine drug tests negative for opioids plus >/=80% of self-reports negative for illicit opioid use from Week 6 to Week 25. Each subject was evaluated as a success or failure for this metric. The percentage of subjects in each group demonstrating treatment success was tested using the Chi-square test. If the subject withdrew from the study, the urine drug tests and self-reports for illicit opioid use for all visits after withdrawal were imputed as positive. If the subject completed the study with missing visits, the missing urine drug tests and self-reports for illicit opioids were imputed as positive. | | Posted | | Count of Participants | | Participants | | Week 6 to Week 25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Chi-squared | | 0.7326 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Cumulative Response Rate | The cumulative response rate was calculated from Week 6 to Week 25 of treatment. Response was defined as the presence of both a negative urine drug test for opioids and a negative self-report for illicit use of opioids at a study visit. The cumulative response rate from Week 6 to Week 25 is calculated by dividing the number of responses from Week 6 to Week 25 by the total number of visits (20), and then multiplying by 100%. The outcome is expressed as the mean percent response in each treatment group. The Kolmogorov-Smirnov method was used to compare the treatment groups. | | Posted | | Mean | Standard Deviation | percent of visits with a response | | Week 6 to Week 25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Cumulative Response Rate - Drug Test for Illicit Use of Opioids | The cumulative response rate for the illicit use of opioids was calculated from Week 6 to Week 25 of treatment. Response was defined as the presence of a negative urine drug test for opioids at a study visit. The cumulative response rate from Week 6 to Week 25 is calculated by dividing the number of responses from Week 6 to Week 25 by the total number of visits (20), and then multiplying by 100%. The outcome is expressed as the mean percent response in each treatment group. The Kolmogorov-Smirnov method was used to compare the treatment groups. | | Posted | | Mean | Standard Deviation | percent of visits with a response | | Week 6 to Week 25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Cumulative Response Rate - Self-reports of Illicit Use of Opioids | The cumulative response rate was calculated from Week 6 to Week 25 of treatment. Response was defined as the presence of a negative self-report for illicit use of opioids at a study visit. The cumulative response rate from Week 6 to Week 25 is calculated by dividing the number of responses from Week 6 to Week 25 by the total number of visits (20) and then multiplying by 100%. The outcome is expressed as the mean percent response in each treatment group. The Kolmogorov-Smirnov method was used to compare the treatment groups. | | Posted | | Mean | Standard Deviation | percent of visits with a response | | Week 6 to Week 25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Percentage of Subjects Abstinent | Abstinence is defined as a subject having urine drug tests negative for opioids as well as self-reports negative for illicit use of opioids at Week 25. Positive urine drug tests or positive timeline followback (TLFB) qualified as not abstinent. Each subject was scored as abstinent or non-abstinent and the groups were compared using a chi-squared test. | | Posted | | Count of Participants | | Participants | | Week 25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Proportion of Subjects Completing the Study | A study completer was defined as a subject who completed either the urine drug screen (UDS) or the self-report assessment at the Week 25 visit. The endpoint completion rate differs from the disposition completion rate because the disposition rate used the study completion definition instead of the UDS or self-report assessment at the Week 25 visit. | | Posted | | Count of Participants | | Participants | | Week 25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Global Clinical Impression - Severity | Clinical global Impression - severity - The severity of opioid dependence was assessed at Week 13 and Week 25 using the following assessment scale: Considering your total clinical experience with this particular population, how mentally ill is the subject at this time? 0 = Not assessed
- = Normal, not at all ill
- = Borderline ill
- = Mildly ill
- = Moderately ill
- = Markedly ill
- = Severely ill
- = Among the most extremely ill subjects
| | Posted | | Mean | Standard Deviation | score on a scale | | Week 13 and Week 25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Clinical Global Impression - Improvement | Clinical global impression - improvement - Improvement in severity of opioid dependence from baseline (study Day 1) was assessed by the Investigator at the visit on Week 13 and Week 25 using the following assessment scale: Rate total improvement whether or not, in your judgement, it is due entirely to drug treatment. Compared to his or her condition at admission to the project, how much has the subject changed? 0 = Not assessed
- = Very much improved
- = Much improved
- = Minimally improved
- = No change
- = Minimally worse
- = Much worse
- = Very much worse
| | Posted | | Mean | Standard Deviation | score on a scale | | Week 13 and Week 25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Opioid Cravings - Change From Baseline | Cravings for opioids were assessed by the subject through the use of a visual analog scale (VAS), where 0 mm represents "no cravings" and 100 mm represents "the most intensive craving I have ever had". The baseline craving VAS assessment was collected on study Day 1 and subsequent assessments were collected at the visit on Weeks 5, 9, 13, 17, 21, and 25. | | Posted | | Mean | Standard Deviation | score on a scale | | Day 1 (baseline) and Weeks 5, 9, 13, 17, 21 and 25. | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Cumulative Response Rate - Illicit Non-opioid Drugs of Abuse | The cumulative response rate was calculated from Week 6 to Week 25 of treatment. Response was defined as the presence of both a negative urine drug test for opioids and a negative self-report for illicit use of non-opioid drugs of abuse at a study visit. The cumulative response rate from Week 6 to Week 25 is calculated by dividing the number of responses from Week 6 to Week 25 by the total number of visits (20) and then multiplying by 100%. The outcome is expressed as the mean percent response in each treatment group. The Kolmogorov-Smirnov method was used to compare the treatment groups. | | Posted | | Mean | Standard Deviation | percent of visits with a response | | Week 6 to Week 25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Resource Use - Number of Hospitalizations | Number of subject hospitalizations weeks 1-25. | | Posted | | Mean | Standard Deviation | hospitalizations | | Weeks 1-25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Resume Productive Activity | Subjects were asked if they were able to resume work, school, or other productive activities. The possible responses were Yes, No, and No Change. Only subjects with non-missing data in each group were included in the analysis. | | Posted | | Count of Participants | | Participants | | Week 25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Resource Use - Emergency Department Visits | Number of subject emergency department visits weeks 1-25. | | Posted | | Mean | Standard Deviation | number of emergency department visits | | Weeks 1-25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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| Secondary | Overdose Events | | | Posted | | Mean | Standard Deviation | overdose events | | Weeks 1-25 | | | | ID | Title | Description |
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| OG000 | SL BUP/NAL SOC Background Therapy | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. | | OG001 | SL BUP/NAL SOC Background Therapy + OXD01 | Sublingual buprenorphine/naloxone titrated to a maintenance dose that suppresses withdrawal signs and symptoms plus OXD01 digital therapy, accessed for 15-30 minutes, 1-2 times per week Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
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