Methamphetamine Use Disorder
Conditions
Keywords
Methamphetamine, Methamphetamine Use Disorder, Naltrexone, Bupropion, Vivitrol®
Brief summary
This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder. Participants will be randomly assigned to the active medication combination (AMC) group or matching placebo group and will receive medications over the course of 12 weeks. Follow-ups will occur in weeks 13 and 16.
Detailed description
There will be 400 adults with moderate or severe methamphetamine use disorder randomized into this multi-site study. Eligibility will be determined during a maximum 21 day screening period. After screening is completed and eligibility is confirmed, including successful administration of a naloxone challenge, participants will begin the 12 week medication phase of the trial. Participants will be randomized to either the 1) AMC arm and receive injections of extended release naltrexone (XR-NTX; as Vivitrol®) plus once-daily oral extended-release bupropion tablets (BUP-XL) or the 2) matching placebo (PLB) arm and receive injections of placebo (iPLB) plus once-daily oral placebo (oPLB) tablets. During the course of the study, participants may be switched to another arm, as determined by the a priori adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched. Overall, approximately 50% of the participants will receive the AMC. Injections will be administered every three weeks, in weeks 1, 4, 7, and 10. Take-home oral study medication (BUP-XL or oPLB) will be dispensed weekly for dosing on non-clinic days. Participants will be asked to attend the clinic twice weekly for observed oral medication dosing, assessments, collection of urine samples, and once-weekly medical management. On non-clinic days, participants will participate in smartphone app-based medication adherence activities. Participants will be asked to complete assessments as indicated on the schedule of assessments. Following the 12 week medication phase, participants will complete a follow-up phase, including a medication taper and post-medication phase follow-up visits during weeks 13 and 16.
Interventions
DRUGNaltrexone: Vivitrol®
Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks
DRUGPlacebo (PLB) Injectable
Placebo: 4 intramuscular injections administered every 3 weeks
DRUGBupropion: Wellbutrin XL®
Bupropion: 450 mg oral dose daily
DRUGPlacebo (PLB) Oral
Placebo: once-daily oral placebo tablets
Sponsors
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
During the study, participants may or may not be switched to another group due to the adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 65 years old; * Interested in reducing/stopping methamphetamine use; * Speak English; * Agree to use acceptable birth control (if applicable); * Be opioid-free at randomization; * Willing to comply with all study procedures and medication instructions; * Agree to use a cell phone (or similar study device) to take videos of medication dosing.
Exclusion criteria
* Medical or psychiatric condition which would make participation unsafe; * Recently participated in a study of pharmacological or behavioral treatment for methamphetamine use disorder; * Recently taken an investigational drug; * Prescribed and taken naltrexone or bupropion ≤ 30 days from consent; * Current or planned extended absence during study period (e.g., jail, surgery, pending legal action); * Currently pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Response During Medication Phase at Stage 1 | At weeks 6 | 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). |
| Number of Participants With Treatment Response During Medication Phase at Stage 2 | At week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period | Weeks 1-4 and Weeks 7-10 | 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 ) |
| Mean Maximum Number of Consecutive Visits Negative UDS at Stage 1 | At week 6 | Measured by maximum consecutive negative UDS: Count the number and range 0-12 and report the maximum number. |
| Mean Maximum Number of Consecutive Visits Negative UDS at Stage 2 | Stage 2 evaluation period at Weeks 12 | Measured by maximum consecutive negative UDS: Count the number and range 0-12 and report the maximum number. |
| Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 1 | At week 6 | Measured by the number of study weeks during the treatment period with two methamphetamine-negative UDS. |
| Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 2 | At week12 | Measured by the number of study weeks during the treatment period with two methamphetamine-negative UDS. |
| Mean Change of Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 1 | Baseline, week 6 | 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. |
| Mean Change Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 2 | week 7, week 12 | 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. |
| Mean Change of Methamphetamine Craving at Stage 1 | Baseline, week 6 | 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. |
| Mean Change of Methamphetamine Craving at Stage 2 | week 7, week 12 | 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. |
| Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | At week 6 | 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. |
| Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | at week 12 | 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. |
| Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 1 | Baseline, week 6 | Proportion of abstinent days of other substance including Alcohol, Cigarettes and E- Cigarettes was measured by self-report on TLFB during the treatment period. |
| Treatment Effectiveness Score of Participants at Stage 1 | At weeks 6 | 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. |
| Mean Change in Number of Other Substance Use by Self-report at Stage 1 | Baseline, week 6 | Number of other substance (Alcohol and Cigarettes) use was measured by self-report recall on Timeline Followback (TLFB) during the treatment period. |
| Mean Change in Number of Other Substance Use by Self-report at Stage 2 | week 7, week 12 | Number of other substance (Alcohol and Cigarettes) use was measured by self-report recall on Timeline Followback (TLFB) during the treatment period. |
| Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 1 | Baseline, week 6 | Proportion of abstinent days of E- Cigarettes was measured by self-report at stage 1. |
| Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 2 | week 7, week 12 | Proportion of abstinent days of E- Cigarettes was measured by self-report at stage 2. |
| Mean Change of Depression Symptom Score by PHQ-9 at Stage 1 | Baseline, week 6 | 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) |
| Mean Change of Depression Symptom Score by PHQ-9 at Stage 2 | week 7, week 12 | 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) |
| Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 1 | Baseline, Week 6 | 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. |
| Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 2 | week 7, week 12 | 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. |
| Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 1 | Baseline, week 6 | 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. |
| Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 2 | week 7, week 12 | 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. |
| Number of Participants Who Completed the Visit in Week 12 | At week 12 | — |
| Participant Satisfaction Rating Measured by Study Satisfaction Survey at the End of the Study | At week 12 | The Study satisfaction survey measures participants satisfaction. We do not have a proper score range (varied range with some free text questions also) |
| Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 2 | week 7, week 12 | Proportion of abstinent days of other substance including Alcohol, Cigarettes and E- Cigarettes was measured by self-report on TLFB during the treatment period. |
| Treatment Effectiveness Score of Participants at Stage 2 | At week 12 | 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. |
Countries
United States
Participant flow
Pre-assignment details
All participants were randomized to either the AMC arm or the Placebo arm in Week 1; thus all are represented in the two Stage 1 categories (total 403). All participants also are represented in Stage 2. Some participants were re-randomized at Week 7 and some were not; thus the four Stage 2 categories also total 403.
Participants by arm
| Arm | Count |
|---|---|
| Active Medication Combination (AMC) injectable extended release naltrexone plus once daily oral extended-release bupropion tablets
Naltrexone: Vivitrol®: Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks
Bupropion: Wellbutrin XL® (Extended release): Bupropion: 450 mg oral dose daily | 109 |
| Matched Placebo (PLB) injectable matching placebo plus once-daily oral placebo tablets
Placebo (PLB) Injectable: Placebo: 4 intramuscular injections administered every 3 weeks
Placebo (PLB) Oral: Placebo: once-daily oral placebo tablets | 294 |
| Total | 403 |
Baseline characteristics
| Characteristic | Total | Matched Placebo (PLB) | Active Medication Combination (AMC) |
|---|---|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 10.1 | 41 years STANDARD_DEVIATION 10 | 41 years STANDARD_DEVIATION 10.6 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 6 participants | 4 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 11 participants | 10 participants | 1 participants |
| Race/Ethnicity, Customized Black/ African American | 48 participants | 38 participants | 10 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 55 participants | 42 participants | 13 participants |
| Race/Ethnicity, Customized Multiracial | 16 participants | 13 participants | 3 participants |
| Race/Ethnicity, Customized Native Hawaiian/ Pacific Islander | 2 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Not Hispanic/ Latino | 345 participants | 249 participants | 96 participants |
| Race/Ethnicity, Customized Other Race | 20 participants | 14 participants | 6 participants |
| Race/Ethnicity, Customized Refused to answer Ethnicity | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Refused to answer Race | 3 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Unknown Ethnicity | 2 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Unknown Race | 10 participants | 8 participants | 2 participants |
| Race/Ethnicity, Customized White | 287 participants | 205 participants | 82 participants |
| Sex: Female, Male Female | 126 Participants | 95 Participants | 31 Participants |
| Sex: Female, Male Male | 277 Participants | 199 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 294 | 0 / 109 | 0 / 111 | 0 / 114 | 0 / 69 | 0 / 109 |
| other Total, other adverse events | 45 / 294 | 41 / 109 | 8 / 111 | 32 / 114 | 0 / 69 | 6 / 109 |
| serious Total, serious adverse events | 4 / 294 | 1 / 109 | 4 / 111 | 3 / 114 | 1 / 69 | 3 / 109 |
Outcome results
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).
Time frame: At weeks 6
Population: Intention to treat analysis was done including drop-out
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1 Placebo | Number of Participants With Treatment Response During Medication Phase at Stage 1 | Responders (Methamphetamine negative UDS results) | 10 Participants |
| Stage 1 Placebo | Number of Participants With Treatment Response During Medication Phase at Stage 1 | Non-responders (Methamphetamine positive UDS results) | 284 Participants |
| Stage 1 AMC | Number of Participants With Treatment Response During Medication Phase at Stage 1 | Responders (Methamphetamine negative UDS results) | 18 Participants |
| Stage 1 AMC | Number of Participants With Treatment Response During Medication Phase at Stage 1 | Non-responders (Methamphetamine positive UDS results) | 91 Participants |
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.
Time frame: At week 12
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1 Placebo | Number of Participants With Treatment Response During Medication Phase at Stage 2 | Responders (Methamphetamine negative UDS results) | 2 Participants |
| Stage 1 Placebo | Number of Participants With Treatment Response During Medication Phase at Stage 2 | Non-Responders (Methamphetamine positive UDS results) | 109 Participants |
| Stage 1 AMC | Number of Participants With Treatment Response During Medication Phase at Stage 2 | Non-Responders (Methamphetamine positive UDS results) | 101 Participants |
| Stage 1 AMC | Number of Participants With Treatment Response During Medication Phase at Stage 2 | Responders (Methamphetamine negative UDS results) | 13 Participants |
| Stage 2 Not Re-Randomized Placebo | Number of Participants With Treatment Response During Medication Phase at Stage 2 | Responders (Methamphetamine negative UDS results) | 9 Participants |
| Stage 2 Not Re-Randomized Placebo | Number of Participants With Treatment Response During Medication Phase at Stage 2 | Non-Responders (Methamphetamine positive UDS results) | 60 Participants |
| Stage 2 Not Re-Randomized AMC | Number of Participants With Treatment Response During Medication Phase at Stage 2 | Responders (Methamphetamine negative UDS results) | 21 Participants |
| Stage 2 Not Re-Randomized AMC | Number of Participants With Treatment Response During Medication Phase at Stage 2 | Non-Responders (Methamphetamine positive UDS results) | 88 Participants |
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.
Time frame: Baseline, week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 1 | -0.064 Proportion of abstinent days | Standard Error 0.009 |
| Stage 1 AMC | Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 1 | -0.072 Proportion of abstinent days | Standard Error 0.016 |
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.
Time frame: week 7, week 12
Population: As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 2 | -0.057 Proportion of abstinent days | Standard Error 0.011 |
| Stage 1 AMC | Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 2 | -0.079 Proportion of abstinent days | Standard Error 0.014 |
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.
Time frame: Baseline, week 6
Population: Intention to treat analysis was done including drop-out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Placebo | Mean Change in Number of Other Substance Use by Self-report at Stage 1 | Alcohol | 0.358 substances | Standard Error 1.503 |
| Stage 1 Placebo | Mean Change in Number of Other Substance Use by Self-report at Stage 1 | Cigarettes | -12.642 substances | Standard Error 7.221 |
| Stage 1 AMC | Mean Change in Number of Other Substance Use by Self-report at Stage 1 | Alcohol | -1.604 substances | Standard Error 3.29 |
| Stage 1 AMC | Mean Change in Number of Other Substance Use by Self-report at Stage 1 | Cigarettes | -55.873 substances | Standard Error 14.154 |
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.
Time frame: week 7, week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Placebo | Mean Change in Number of Other Substance Use by Self-report at Stage 2 | Alcohol | 1.695 substances | Standard Error 1.779 |
| Stage 1 Placebo | Mean Change in Number of Other Substance Use by Self-report at Stage 2 | Cigarettes | -9.925 substances | Standard Error 7.801 |
| Stage 1 AMC | Mean Change in Number of Other Substance Use by Self-report at Stage 2 | Alcohol | -2.942 substances | Standard Error 3.121 |
| Stage 1 AMC | Mean Change in Number of Other Substance Use by Self-report at Stage 2 | Cigarettes | -58.591 substances | Standard Error 14.594 |
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)
Time frame: Baseline, week 6
Population: Intention to treat analysis was done including drop-out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Change of Depression Symptom Score by PHQ-9 at Stage 1 | -3.26 score on a scale | Standard Error 0.34 |
| Stage 1 AMC | Mean Change of Depression Symptom Score by PHQ-9 at Stage 1 | -4.78 score on a scale | Standard Error 0.7 |
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)
Time frame: week 7, week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Change of Depression Symptom Score by PHQ-9 at Stage 2 | -3.66 score on a scale | Standard Deviation 0.37 |
| Stage 1 AMC | Mean Change of Depression Symptom Score by PHQ-9 at Stage 2 | -4.39 score on a scale | Standard Deviation 0.64 |
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.
Time frame: Baseline, week 6
Population: Intention to treat analysis was done including drop-out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Change of Methamphetamine Craving at Stage 1 | -22.33 score on a scale | Standard Error 1.82 |
| Stage 1 AMC | Mean Change of Methamphetamine Craving at Stage 1 | -29.98 score on a scale | Standard Error 3.17 |
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.
Time frame: week 7, week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Change of Methamphetamine Craving at Stage 2 | -20.52 score on a scale | Standard Error 1.72 |
| Stage 1 AMC | Mean Change of Methamphetamine Craving at Stage 2 | -31.79 score on a scale | Standard Error 3.17 |
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.
Time frame: Baseline, week 6
Population: Intention to treat analysis was done including drop-out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 1 | 2.2 score on a scale | Standard Error 1 |
| Stage 1 AMC | Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 1 | 6.5 score on a scale | Standard Error 1.5 |
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.
Time frame: week 7, week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 2 | 2.5 score on a scale | Standard Deviation 1.1 |
| Stage 1 AMC | Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 2 | 6.2 score on a scale | Standard Deviation 1.5 |
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.
Time frame: Baseline, week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Change of Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 1 | 14.0 percentage of abstinent days | Standard Error 1.3 |
| Stage 1 AMC | Mean Change of Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 1 | 27.2 percentage of abstinent days | Standard Error 2.88 |
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.
Time frame: Baseline, week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Placebo | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 1 | Alcohol | -0.054 proportion of abstinent days | Standard Error 0.011 |
| Stage 1 Placebo | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 1 | Cigarettes | 0.054 proportion of abstinent days | Standard Error 0.01 |
| Stage 1 Placebo | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 1 | E- Cigarettes | -0.064 proportion of abstinent days | Standard Error 0.009 |
| Stage 1 AMC | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 1 | Alcohol | -0.016 proportion of abstinent days | Standard Error 0.017 |
| Stage 1 AMC | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 1 | Cigarettes | 0.103 proportion of abstinent days | Standard Error 0.021 |
| Stage 1 AMC | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 1 | E- Cigarettes | -0.072 proportion of abstinent days | Standard Error 0.016 |
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.
Time frame: week 7, week 12
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Placebo | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 2 | Alcohol | -0.035 proportion of abstinent days | Standard Error 0.012 |
| Stage 1 Placebo | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 2 | Cigarettes | 0.038 proportion of abstinent days | Standard Error 0.012 |
| Stage 1 Placebo | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 2 | E- Cigarettes | -0.057 proportion of abstinent days | Standard Error 0.011 |
| Stage 1 AMC | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 2 | Alcohol | -0.035 proportion of abstinent days | Standard Error 0.016 |
| Stage 1 AMC | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 2 | Cigarettes | 0.119 proportion of abstinent days | Standard Error 0.022 |
| Stage 1 AMC | Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 2 | E- Cigarettes | -0.079 proportion of abstinent days | Standard Error 0.014 |
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.
Time frame: Baseline, Week 6
Population: Intention to treat analysis was done including drop-out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Placebo | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 1 | Physical Health | 1.013 score on a scale | Standard Error 0.805 |
| Stage 1 Placebo | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 1 | Mental Health | 1.071 score on a scale | Standard Error 0.842 |
| Stage 1 Placebo | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 1 | General Health | -1.168 score on a scale | Standard Error 0.957 |
| Stage 1 AMC | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 1 | Physical Health | 1.425 score on a scale | Standard Error 1.225 |
| Stage 1 AMC | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 1 | Mental Health | 3.785 score on a scale | Standard Error 1.38 |
| Stage 1 AMC | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 1 | General Health | 1.582 score on a scale | Standard Error 1.442 |
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.
Time frame: week 7, week 12
Population: As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Placebo | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 2 | Physical Health | 0.877 score on a scale | Standard Error 0.87 |
| Stage 1 Placebo | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 2 | Mental Health | 2.035 score on a scale | Standard Error 0.917 |
| Stage 1 Placebo | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 2 | General Health | 0.262 score on a scale | Standard Error 1.038 |
| Stage 1 AMC | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 2 | Physical Health | 1.561 score on a scale | Standard Error 1.147 |
| Stage 1 AMC | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 2 | Mental Health | 2.821 score on a scale | Standard Error 1.345 |
| Stage 1 AMC | Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 2 | General Health | 0.152 score on a scale | Standard Error 1.365 |
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.
Time frame: week 7, week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Change Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 2 | 16 percentage of abstinent days | Standard Error 1.5 |
| Stage 1 AMC | Mean Change Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 2 | 25.3 percentage of abstinent days | Standard Error 2.6 |
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.
Time frame: At week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Maximum Number of Consecutive Visits Negative UDS at Stage 1 | 0.54 UDS test results | Standard Deviation 1.31 |
| Stage 1 AMC | Mean Maximum Number of Consecutive Visits Negative UDS at Stage 1 | 1.37 UDS test results | Standard Deviation 2.5 |
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.
Time frame: Stage 2 evaluation period at Weeks 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Maximum Number of Consecutive Visits Negative UDS at Stage 2 | 0.61 UDS test results | Standard Deviation 1.46 |
| Stage 1 AMC | Mean Maximum Number of Consecutive Visits Negative UDS at Stage 2 | 1.18 UDS test results | Standard Deviation 2.72 |
| Stage 2 Not Re-Randomized Placebo | Mean Maximum Number of Consecutive Visits Negative UDS at Stage 2 | 3.10 UDS test results | Standard Deviation 4.39 |
| Stage 2 Not Re-Randomized AMC | Mean Maximum Number of Consecutive Visits Negative UDS at Stage 2 | 2.63 UDS test results | Standard Deviation 4.13 |
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.
Time frame: At week 6
Population: Intention to treat analysis was done including drop-out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Placebo | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | Non-Methamphetamine Drug | 28.53 days | Standard Deviation 14.7 |
| Stage 1 Placebo | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | Alcohol | 36.44 days | Standard Deviation 9.5 |
| Stage 1 Placebo | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | Cocaine | 41.87 days | Standard Deviation 0.6 |
| Stage 1 Placebo | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | Cigarettes | 15.29 days | Standard Deviation 18.7 |
| Stage 1 Placebo | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | Amphetamine | 41.89 days | Standard Deviation 1 |
| Stage 1 AMC | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | Cigarettes | 16.31 days | Standard Deviation 18.2 |
| Stage 1 AMC | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | Amphetamine | 41.95 days | Standard Deviation 0.3 |
| Stage 1 AMC | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | Non-Methamphetamine Drug | 31.47 days | Standard Deviation 13.8 |
| Stage 1 AMC | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | Cocaine | 41.87 days | Standard Deviation 0.5 |
| Stage 1 AMC | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 | Alcohol | 37.89 days | Standard Deviation 7.2 |
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.
Time frame: at week 12
Population: As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Placebo | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | Non-Methamphetamine drug | 30.99 days | Standard Deviation 15.2 |
| Stage 1 Placebo | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | Alcohol | 38.41 days | Standard Deviation 11.9 |
| Stage 1 Placebo | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | Cocaine | 44.9 days | Standard Deviation 0.4 |
| Stage 1 Placebo | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | Cigarettes | 17.11 days | Standard Deviation 20 |
| Stage 1 Placebo | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | Amphetamine | 44.96 days | Standard Deviation 0.3 |
| Stage 1 AMC | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | Cigarettes | 19.31 days | Standard Deviation 20.1 |
| Stage 1 AMC | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | Amphetamine | 44.95 days | Standard Deviation 0.3 |
| Stage 1 AMC | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | Non-Methamphetamine drug | 31.05 days | Standard Deviation 16.1 |
| Stage 1 AMC | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | Cocaine | 44.88 days | Standard Deviation 0.5 |
| Stage 1 AMC | Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 | Alcohol | 39.91 days | Standard Deviation 9.1 |
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.
Time frame: At week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 1 | 0.15 weeks | Standard Deviation 0.55 |
| Stage 1 AMC | Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 1 | 0.56 weeks | Standard Deviation 1.2 |
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.
Time frame: At week12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 2 | 0.20 weeks | Standard Deviation 0.7 |
| Stage 1 AMC | Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 2 | 0.50 weeks | Standard Deviation 1.35 |
| Stage 2 Not Re-Randomized Placebo | Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 2 | 1.48 weeks | Standard Deviation 2.21 |
| Stage 2 Not Re-Randomized AMC | Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 2 | 1.20 weeks | Standard Deviation 2.08 |
Secondary
Number of Participants Who Completed the Visit in Week 12
Time frame: At week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 Placebo | Number of Participants Who Completed the Visit in Week 12 | 106 Participants |
| Stage 1 AMC | Number of Participants Who Completed the Visit in Week 12 | 103 Participants |
| Stage 2 Not Re-Randomized Placebo | Number of Participants Who Completed the Visit in Week 12 | 28 Participants |
| Stage 2 Not Re-Randomized AMC | Number of Participants Who Completed the Visit in Week 12 | 78 Participants |
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)
Time frame: At week 12
Population: We did not collect data about satisfaction.
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 )
Time frame: Weeks 1-4 and Weeks 7-10
Population: Intention to treat analysis was done including drop-out.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Placebo | Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period | 5.10 percentage of participants |
| Stage 1 AMC | Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period | 11.93 percentage of participants |
| Stage 2 Not Re-Randomized Placebo | Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period | 7.95 percentage of participants |
| Stage 2 Not Re-Randomized AMC | Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period | 10.20 percentage of participants |
| Stage 2 Not Re-Randomized Placebo | Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period | 29.46 percentage of participants |
| Stage 2 Not Re-Randomized AMC | Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period | 22.56 percentage of participants |
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.
Time frame: At weeks 6
Population: Intention to treat analysis was done including drop-out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Treatment Effectiveness Score of Participants at Stage 1 | 5.72 percentage of urine drug screens | Standard Deviation 13.41 |
| Stage 1 AMC | Treatment Effectiveness Score of Participants at Stage 1 | 13.84 percentage of urine drug screens | Standard Deviation 22.97 |
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.
Time frame: At week 12
Population: As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 Placebo | Treatment Effectiveness Score of Participants at Stage 2 | 7.45 percentage of urine drug screens | Standard Deviation 16.02 |
| Stage 1 AMC | Treatment Effectiveness Score of Participants at Stage 2 | 11.55 percentage of urine drug screens | Standard Deviation 24.55 |