| Primary | Number of Participants With Treatment Response During Medication Phase at Stage 1 | Treatment response is defined as 'Responder' and 'Non-Responder'. Responder : Participant who meet responder criterion by providing at least 3 out of a possible 4 methamphetamine-negative urine tests at the end of stage 1 (weeks 5-6). Non-Responder: All other participants without 3 or 4 methamphetamine-negative UDS (Urine Drug Screen). | Intention to treat analysis was done including drop-out | Posted | | Count of Participants | | Participants | | At weeks 6 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
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| Responders (Methamphetamine negative UDS results) | | | Non-responders (Methamphetamine positive UDS results) | |
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| Primary | Number of Participants With Treatment Response During Medication Phase at Stage 2 | Treatment response is defined as 'Responder' and 'Non-Responder'. Responder : Participant who meet responder criterion by providing at least 3 out of a possible 4 methamphetamine-negative urine tests at the end of stage 1 (weeks 5-6). Non-Responder: All other participants without 3 or 4 methamphetamine-negative UDS. | | Posted | | Count of Participants | | Participants | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) | | OG002 | Stage 2 Not Re-Randomized Placebo | Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12). |
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| Secondary | Treatment Effectiveness Score of Participants at Stage 1 | The Treatment Effectiveness Score (TES) as measured by UDS results, during the treatment period. The TES is the percentage of the expected urine drug screens that were negative for each drug. Twelve urine drug screens are expected within each stage. | Intention to treat analysis was done including drop-out | Posted | | Mean | Standard Deviation | percentage of urine drug screens | | At weeks 6 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
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| Secondary | Treatment Effectiveness Score of Participants at Stage 2 | The Treatment Effectiveness Score (TES) as measured by UDS results, during the treatment period. The TES is the percentage of the expected urine drug screens that were negative for each drug. Twelve urine drug screens are expected within each stage. The range of possible scores are 0-100 and higher score indicates better outcomes. | As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC) | Posted | | Mean | Standard Deviation | percentage of urine drug screens | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) |
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| Secondary | Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period | Methamphetamine use, as measured by UDS (urine drug screen) in the pre-evaluation period (Weeks 1-4 for Stage 1 and Weeks 7-10 for Stage 2 ) | Intention to treat analysis was done including drop-out. | Posted | | Number | | percentage of participants | | Weeks 1-4 and Weeks 7-10 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). | | OG002 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG003 | Stage 2 Re-Randomized AMC | |
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| Secondary | Mean Maximum Number of Consecutive Visits Negative UDS at Stage 1 | Measured by maximum consecutive negative UDS: Count the number and range 0-12 and report the maximum number. | | Posted | | Mean | Standard Deviation | UDS test results | | At week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Those participants randomized to the Placebo arm in Stage 1 | | OG001 | AMC (Active Medication Combination Arm) | Those participants who were randomized to the Active Medication Combination arm in Stage 1 |
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| Secondary | Mean Maximum Number of Consecutive Visits Negative UDS at Stage 2 | Measured by maximum consecutive negative UDS: Count the number and range 0-12 and report the maximum number. | | Posted | | Mean | Standard Deviation | UDS test results | | Stage 2 evaluation period at Weeks 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants randomized to the Placebo arm in Stage 2 | | OG001 | Stage 2 Re-Randomized AMC (Active Medication Combination Arm) | Those participants who were randomized to the Active Medication Combination arm in Stage 2 | | OG002 | Stage 2 Not Re-Randomized Placebo | Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12). | | OG003 | Stage 2 Not Re-Randomized AMC | All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
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| Secondary | Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 1 | Measured by the number of study weeks during the treatment period with two methamphetamine-negative UDS. | | Posted | | Mean | Standard Deviation | weeks | | At week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Those participants randomized to the Placebo arm in Stage 1 | | OG001 | AMC (Active Medication Combination) | Those participants who were randomized to the Active Medication Combination arm in Stage 1 |
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| Secondary | Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 2 | Measured by the number of study weeks during the treatment period with two methamphetamine-negative UDS. | | Posted | | Mean | Standard Deviation | weeks | | At week12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) | | OG002 | Stage 2 Not Re-Randomized Placebo | Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12). | | OG003 | Stage 2 Not Re-Randomized AMC |
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| Secondary | Mean Change of Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 1 | Methamphetamine use selfreported on TLFB ( Timeline Followback) during the follow-up period. The baseline measure is the percentage of abstinent days in the 30 days prior to randomization. The outcome is the change in percentage of abstinent days. | | Posted | | Mean | Standard Error | percentage of abstinent days | | Baseline, week 6 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
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| Secondary | Mean Change Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 2 | Methamphetamine use selfreported on TLFB ( Timeline Followback) during the follow-up period. The baseline measure is the percentage of abstinent days in the 30 days prior to randomization. The outcome is the change in percentage of abstinent days. | These numbers come from a model which does not use the Stage 2 Not rerandomized data. As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). Data for Not Re-Randomized groups at stage 2 were not included for the main analysis, thus not reported | Posted | | Mean | Standard Error | percentage of abstinent days | | week 7, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) |
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| Secondary | Mean Change of Methamphetamine Craving at Stage 1 | Severity of methamphetamine craving, as measured by Visual Analog Craving Scales (VAS), during the treatment period. VAS scores range from 0 (no craving) to 100 (most intense craving possible). The VAS is completed at screening, once a week during the treatment period, and at the follow-up visits. | Intention to treat analysis was done including drop-out | Posted | | Mean | Standard Error | score on a scale | | Baseline, week 6 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
| |
| Secondary | Mean Change of Methamphetamine Craving at Stage 2 | Severity of methamphetamine craving, as measured by Visual Analog Craving Scales (VAS), during the treatment period. VAS scores range from 0 (no craving) to 100 (most intense craving possible). The VAS is completed at screening, once a week during the treatment period, and at the follow-up visits. | As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). Data for Not Re-Randomized groups at stage 2 were not included for the main analysis, thus not reported | Posted | | Mean | Standard Error | score on a scale | | week 7, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) |
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| Secondary | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | Other substance use including Amphetamine, Non-Methamphetamine Drug, Cocaine, Alcohol, Cigarettes, as measured by UDS, during the treatment period. Opioid use will also be assessed using the Opioid 2000 ng tests on the UDS. | Intention to treat analysis was done including drop-out | Posted | | Mean | Standard Deviation | days | | At week 6 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
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| Secondary | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | Other substance use including Amphetamine, Non-Methamphetamine Drug, Cocaine, Alcohol, Cigarettes, as measured by UDS, during the treatment period. Opioid use will also be assessed using the Opioid 2000 ng tests on the UDS. | As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC) | Posted | | Mean | Standard Deviation | days | | at week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) |
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| Secondary | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 1 | Proportion of abstinent days of other substance including Alcohol, Cigarettes and E- Cigarettes was measured by self-report on TLFB during the treatment period. | | Posted | | Mean | Standard Error | proportion of abstinent days | | Baseline, week 6 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
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| Secondary | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 2 | Proportion of abstinent days of other substance including Alcohol, Cigarettes and E- Cigarettes was measured by self-report on TLFB during the treatment period. | These numbers come from a model which does not use the Stage 2 Not rerandomized data. As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). Data for Not Re-Randomized groups at stage 2 were not included for the main analysis, thus not reported | Posted | | Mean | Standard Error | proportion of abstinent days | | week 7, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) |
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| Secondary | Mean Change in Number of Other Substance Use by Self-report at Stage 1 | Number of other substance (Alcohol and Cigarettes) use was measured by self-report recall on Timeline Followback (TLFB) during the treatment period. | Intention to treat analysis was done including drop-out | Posted | | Mean | Standard Error | substances | | Baseline, week 6 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
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| Secondary | Mean Change in Number of Other Substance Use by Self-report at Stage 2 | Number of other substance (Alcohol and Cigarettes) use was measured by self-report recall on Timeline Followback (TLFB) during the treatment period. | As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). These numbers come from a model which does not use the Stage 2 Not rerandomized data so we do not have any estimates for the same. | Posted | | Mean | Standard Error | substances | | week 7, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) |
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| Secondary | Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 1 | Proportion of abstinent days of E- Cigarettes was measured by self-report at stage 1. | | Posted | | Mean | Standard Error | Proportion of abstinent days | | Baseline, week 6 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
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| Secondary | Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 2 | Proportion of abstinent days of E- Cigarettes was measured by self-report at stage 2. | As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC) | Posted | | Mean | Standard Error | Proportion of abstinent days | | week 7, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) |
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| Secondary | Mean Change of Depression Symptom Score by PHQ-9 at Stage 1 | Patient Health Questionnaire-9 (PHQ-9) measures participants depression symptoms. Possible scores range from 0-27, with higher scores indicating a more severe depression symptoms. PHQ-9 scores reflect depression severity, ranges from 0-27 (0 no depressive symptoms, 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression) | Intention to treat analysis was done including drop-out | Posted | | Mean | Standard Error | score on a scale | | Baseline, week 6 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
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| Secondary | Mean Change of Depression Symptom Score by PHQ-9 at Stage 2 | Patient Health Questionnaire-9 measures participants depression symptoms. Possible scores range from 0-27, with higher scores indicating a more severe depression symptoms. PHQ-9 scores reflect depression severity, ranges from 0-27 (0 no depressive symptoms, 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression) | As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). Data for Not Re-Randomized groups at stage 2 were not included for the main analysis, thus not reported | Posted | | Mean | Standard Deviation | score on a scale | | week 7, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) |
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| Secondary | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 1 | Mean change score of QOL (General health, Physical health, and Mental health) from baseline will be assessed by PhenX (Phenotypes and eXposures) Core Tier 1 instrument: Quality of Life (QOL), which measures participants' quality of life during the past 30 days. Possible scores range from 0 to 30 (number of days in the past 30 in which health was good), with higher scores indicating a better quality of life. | Intention to treat analysis was done including drop-out | Posted | | Mean | Standard Error | score on a scale | | Baseline, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
| |
| Secondary | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 2 | Mean change score of QOL (General health, Physical health, and Mental health) from baseline will be assessed by PhenX Core Tier 1 instrument: Quality of Life (QOL), which measures participants' quality of life during the past 30 days. Possible scores range from 0 to 30 (number of days in the past 30 in which health was good), with higher scores indicating a better quality of life. | As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC) | Posted | | Mean | Standard Error | score on a scale | | week 7, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) |
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| Secondary | Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 1 | The Treatment Effectiveness Assessment is a 4-item self-administered assessment that uses a Likert scale (1-10) to document changes in four life domains: substance use, health, lifestyle, and community and is collected at screening, mid-treatment (Week 6 Visit 2) and end-of-treatment (Week 12 Visit 2). Possible scores range from 4-40, with higher scores indicating a higher overall functioning. | Intention to treat analysis was done including drop-out | Posted | | Mean | Standard Error | score on a scale | | Baseline, week 6 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
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| Secondary | Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 2 | The Treatment Effectiveness Assessment is a 4-item self-administered assessment that uses a Likert scale (1-10) to document changes in four life domains: substance use, health, lifestyle, and community and is collected at screening, mid-treatment (Week 6 Visit 2) and end-of-treatment (Week 12 Visit 2). Possible scores range from 4-40, with higher scores indicating a higher overall functioning. | As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). Data for Not Re-Randomized groups at stage 2 were not included for the main analysis, thus not reported | Posted | | Mean | Standard Deviation | score on a scale | | week 7, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) |
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| Secondary | Number of Participants Who Completed the Visit in Week 12 | | | Posted | | Count of Participants | | Participants | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG001 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) | | OG002 | Stage 2 Not Re-Randomized Placebo | Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12). | | OG003 | Stage 2 Not Re-Randomized AMC | All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12). |
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| Secondary | Participant Satisfaction Rating Measured by Study Satisfaction Survey at the End of the Study | The Study satisfaction survey measures participants satisfaction. We do not have a proper score range (varied range with some free text questions also) | We did not collect data about satisfaction. | Posted | | | | | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1 Placebo | Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7. | | OG001 | Stage 1 AMC | Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12). | | OG002 | Stage 2 Re-Randomized Placebo | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7). | | OG003 | Stage 2 Re-Randomized AMC | Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7) |
|