A Phase 3 interventional study of Naltrexone: Vivitrol® and Placebo (PLB) Injectable in Methamphetamine Use Disorder, sponsored by University of Texas Southwestern Medical Center. Completed at 8 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-05-03.
Sponsored by University of Texas Southwestern Medical Center · Phase 3, Interventional, and Treatment
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.
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.
University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
injectable extended release naltrexone plus once daily oral extended-release bupropion tablets
Drug: Naltrexone: Vivitrol® · Drug: Bupropion: Wellbutrin XL®
injectable matching placebo plus once-daily oral placebo tablets
Drug: Placebo (PLB) Injectable · Drug: Placebo (PLB) Oral
Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks
Also known as: Arm: Experimental - Active Medication Combination (AMC)
Placebo: 4 intramuscular injections administered every 3 weeks
Also known as: Injectable matching (to Naltrexone) placebo, Arm: Placebo Comparator - matched Placebo (PLB)
Bupropion: 450 mg oral dose daily
Also known as: Arm: Experimental - Active Medication Combination (AMC)
Placebo: once-daily oral placebo tablets
Also known as: Oral matching (to Bupropion) placebo tablets, Arm: Placebo Comparator - matched Placebo (PLB)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Number of Participants Who Completed the Visit in Week 12
Time frame: At week 12
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
| Milestone | Stage 1 Placebo Non-responders Re-randomized to Placebo at Stage 2 | Stage 1 Placebo Non-responders Re-randomized to AMC at Stage 2 | Stage 1 Placebo Non-responders Not Re-randomized at Stage 2 | Stage 1 Placebo Responders Not Re-randomized at Stage 2 | Stage 1 AMC Remaining on AMC at Stage 2 |
|---|---|---|---|---|---|
| Started | 111 | 114 | 59 | 10 | 109 |
| Completed | 106 | 103 | 19 | 9 | 78 |
| Not completed | 5 | 11 | 40 | 1 | 31 |
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).
| Participants | Stage 1 Placebo | Stage 1 AMC |
|---|---|---|
| Responders (Methamphetamine negative UDS results) | 10 | 18 |
| Non-responders (Methamphetamine positive UDS results) | 284 | 91 |
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.
| Participants | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC | Stage 2 Not Re-Randomized Placebo | Stage 2 Not Re-Randomized AMC |
|---|---|---|---|---|
| Responders (Methamphetamine negative UDS results) | 2 | 13 | 9 | 21 |
| Non-Responders (Methamphetamine positive UDS results) | 109 | 101 | 60 | 88 |
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.
| percentage of urine drug screens | Stage 1 Placebo | Stage 1 AMC |
|---|---|---|
| Treatment Effectiveness Score of Participants at Stage 1 | 5.72 ± 13.41 | 13.84 ± 22.97 |
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.
| percentage of urine drug screens | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC |
|---|---|---|
| Treatment Effectiveness Score of Participants at Stage 2 | 7.45 ± 16.02 | 11.55 ± 24.55 |
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 )
| percentage of participants | Stage 1 Placebo | Stage 1 AMC | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC | Stage 2 Not Re-Randomized Placebo | Stage 2 Not Re-Randomized AMC |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period | 5.10 | 11.93 | 7.95 | 10.20 | 29.46 | 22.56 |
Measured by maximum consecutive negative UDS: Count the number and range 0-12 and report the maximum number.
| UDS test results | Placebo | AMC (Active Medication Combination Arm) |
|---|---|---|
| Mean Maximum Number of Consecutive Visits Negative UDS at Stage 1 | 0.54 ± 1.31 | 1.37 ± 2.50 |
Measured by maximum consecutive negative UDS: Count the number and range 0-12 and report the maximum number.
| UDS test results | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC (Active Medication Combination Arm) | Stage 2 Not Re-Randomized Placebo | Stage 2 Not Re-Randomized AMC |
|---|---|---|---|---|
| Mean Maximum Number of Consecutive Visits Negative UDS at Stage 2 | 0.61 ± 1.46 | 1.18 ± 2.72 | 3.10 ± 4.39 | 2.63 ± 4.13 |
Measured by the number of study weeks during the treatment period with two methamphetamine-negative UDS.
| weeks | Placebo | AMC (Active Medication Combination) |
|---|---|---|
| Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 1 | 0.15 ± 0.55 | 0.56 ± 1.20 |
Measured by the number of study weeks during the treatment period with two methamphetamine-negative UDS.
| weeks | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC | Stage 2 Not Re-Randomized Placebo | Stage 2 Not Re-Randomized AMC |
|---|---|---|---|---|
| Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 2 | 0.20 ± 0.70 | 0.50 ± 1.35 | 1.48 ± 2.21 | 1.20 ± 2.08 |
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.
| percentage of abstinent days | Stage 1 Placebo | Stage 1 AMC |
|---|---|---|
| Mean Change of Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 1 | 14.0 ± 1.3 | 27.2 ± 2.88 |
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.
| percentage of abstinent days | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC |
|---|---|---|
| Mean Change Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 2 | 16 ± 1.5 | 25.3 ± 2.6 |
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.
| score on a scale | Stage 1 Placebo | Stage 1 AMC |
|---|---|---|
| Mean Change of Methamphetamine Craving at Stage 1 | -22.33 ± 1.82 | -29.98 ± 3.17 |
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.
| score on a scale | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC |
|---|---|---|
| Mean Change of Methamphetamine Craving at Stage 2 | -20.52 ± 1.72 | -31.79 ± 3.17 |
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.
| days | Stage 1 Placebo | Stage 1 AMC |
|---|---|---|
| Amphetamine | 41.89 ± 1.0 | 41.95 ± 0.3 |
| Non-Methamphetamine Drug | 28.53 ± 14.7 | 31.47 ± 13.8 |
| Cocaine | 41.87 ± 0.6 | 41.87 ± 0.5 |
| Alcohol | 36.44 ± 9.5 | 37.89 ± 7.2 |
| Cigarettes | 15.29 ± 18.7 | 16.31 ± 18.2 |
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.
| days | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC |
|---|---|---|
| Amphetamine | 44.96 ± 0.3 | 44.95 ± 0.3 |
| Non-Methamphetamine drug | 30.99 ± 15.2 | 31.05 ± 16.1 |
| Cocaine | 44.9 ± 0.4 | 44.88 ± 0.5 |
| Alcohol | 38.41 ± 11.9 | 39.91 ± 9.1 |
| Cigarettes | 17.11 ± 20.0 | 19.31 ± 20.1 |
Proportion of abstinent days of other substance including Alcohol, Cigarettes and E- Cigarettes was measured by self-report on TLFB during the treatment period.
| proportion of abstinent days | Stage 1 Placebo | Stage 1 AMC |
|---|---|---|
| Alcohol | -0.054 ± 0.011 | -0.016 ± 0.017 |
| Cigarettes | 0.054 ± 0.010 | 0.103 ± 0.021 |
| E- Cigarettes | -0.064 ± 0.009 | -0.072 ± 0.016 |
Proportion of abstinent days of other substance including Alcohol, Cigarettes and E- Cigarettes was measured by self-report on TLFB during the treatment period.
| proportion of abstinent days | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC |
|---|---|---|
| Alcohol | -0.035 ± 0.012 | -0.035 ± 0.016 |
| Cigarettes | 0.038 ± 0.012 | 0.119 ± 0.022 |
| E- Cigarettes | -0.057 ± 0.011 | -0.079 ± 0.014 |
Number of other substance (Alcohol and Cigarettes) use was measured by self-report recall on Timeline Followback (TLFB) during the treatment period.
| substances | Stage 1 Placebo | Stage 1 AMC |
|---|---|---|
| Alcohol | 0.358 ± 1.503 | -1.604 ± 3.290 |
| Cigarettes | -12.642 ± 7.221 | -55.873 ± 14.154 |
Number of other substance (Alcohol and Cigarettes) use was measured by self-report recall on Timeline Followback (TLFB) during the treatment period.
| substances | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC |
|---|---|---|
| Alcohol | 1.695 ± 1.779 | -2.942 ± 3.121 |
| Cigarettes | -9.925 ± 7.801 | -58.591 ± 14.594 |
Proportion of abstinent days of E- Cigarettes was measured by self-report at stage 1.
| Proportion of abstinent days | Stage 1 Placebo | Stage 1 AMC |
|---|---|---|
| Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 1 | -0.064 ± 0.009 | -0.072 ± 0.016 |
Proportion of abstinent days of E- Cigarettes was measured by self-report at stage 2.
| Proportion of abstinent days | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC |
|---|---|---|
| Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 2 | -0.057 ± 0.011 | -0.079 ± 0.014 |
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)
| score on a scale | Stage 1 Placebo | Stage 1 AMC |
|---|---|---|
| Mean Change of Depression Symptom Score by PHQ-9 at Stage 1 | -3.26 ± 0.34 | -4.78 ± 0.70 |
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)
| score on a scale | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC |
|---|---|---|
| Mean Change of Depression Symptom Score by PHQ-9 at Stage 2 | -3.66 ± 0.37 | -4.39 ± 0.64 |
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.
| score on a scale | Stage 1 Placebo | Stage 1 AMC |
|---|---|---|
| Physical Health | 1.013 ± 0.805 | 1.425 ± 1.225 |
| Mental Health | 1.071 ± 0.842 | 3.785 ± 1.380 |
| General Health | -1.168 ± 0.957 | 1.582 ± 1.442 |
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.
| score on a scale | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC |
|---|---|---|
| Physical Health | 0.877 ± 0.870 | 1.561 ± 1.147 |
| Mental Health | 2.035 ± 0.917 | 2.821 ± 1.345 |
| General Health | 0.262 ± 1.038 | 0.152 ± 1.365 |
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.
| score on a scale | Stage 1 Placebo | Stage 1 AMC |
|---|---|---|
| Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 1 | 2.2 ± 1.0 | 6.5 ± 1.5 |
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.
| score on a scale | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC |
|---|---|---|
| Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 2 | 2.5 ± 1.1 | 6.2 ± 1.5 |
| Participants | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC | Stage 2 Not Re-Randomized Placebo | Stage 2 Not Re-Randomized AMC |
|---|---|---|---|---|
| Number of Participants Who Completed the Visit in Week 12 | 106 | 103 | 28 | 78 |
The Study satisfaction survey measures participants satisfaction. We do not have a proper score range (varied range with some free text questions also)
No measurements were reported for this outcome.
Collected over Baseline to 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stage 1 Placebo | 0/294 (0%) | 4/294 (1.4%) | 45/294 (15.3%) |
| Stage 1 AMC | 0/109 (0%) | 1/109 (0.9%) | 41/109 (37.6%) |
| Stage 2 Re-Randomized Placebo | 0/111 (0%) | 4/111 (3.6%) | 8/111 (7.2%) |
| Stage 2 Re-Randomized AMC | 0/114 (0%) | 3/114 (2.6%) | 32/114 (28.1%) |
| Stage 2 Not Re-Randomized Placebo | 0/69 (0%) | 1/69 (1.4%) | 0/69 (0%) |
| Stage 2 Not Re-Randomized AMC | 0/109 (0%) | 3/109 (2.8%) | 6/109 (5.5%) |
| Event | Stage 1 Placebo | Stage 1 AMC | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC | Stage 2 Not Re-Randomized Placebo | Stage 2 Not Re-Randomized AMC |
|---|---|---|---|---|---|---|
| AppendicitisInfections and infestations | 0/294 | 0/109 | 0/111 | 0/114 | 1/69 | 0/109 |
| GastroenteritisInfections and infestations | 0/294 | 1/109 | 1/111 | 0/114 | 0/69 | 0/109 |
| PneumoniaInfections and infestations | 0/294 | 0/109 | 1/111 | 0/114 | 0/69 | 1/109 |
| Cardiac failure acuteCardiac disorders | 0/294 | 0/109 | 0/111 | 0/114 | 0/69 | 1/109 |
| DepressionPsychiatric disorders | 0/294 | 0/109 | 0/111 | 0/114 | 0/69 | 1/109 |
| UrosepsisInfections and infestations | 0/294 | 0/109 | 1/111 | 0/114 | 0/69 | 0/109 |
| Victim of crimeSocial circumstances | 0/294 | 0/109 | 1/111 | 0/114 | 0/69 | 0/109 |
| CellulitisInfections and infestations | 0/294 | 0/109 | 0/111 | 1/114 | 0/69 | 0/109 |
| Neck painMusculoskeletal and connective tissue disorders | 0/294 | 0/109 | 0/111 | 1/114 | 0/69 | 0/109 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/294 | 0/109 | 0/111 | 1/114 | 0/69 | 0/109 |
| Event | Stage 1 Placebo | Stage 1 AMC | Stage 2 Re-Randomized Placebo | Stage 2 Re-Randomized AMC | Stage 2 Not Re-Randomized Placebo | Stage 2 Not Re-Randomized AMC |
|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 45/294 | 41/109 | 8/111 | 32/114 | 0/69 | 6/109 |
The Baseline characteristics are based on stage 1 assignment
| Age, Continuous(years) | Active Medication Combination (AMC) | Matched Placebo (PLB) | Total |
|---|---|---|---|
| Mean | 41 ± 10.6 | 41 ± 10.0 | 41 ± 10.1 |
| Sex: Female, Male(Participants) | Active Medication Combination (AMC) | Matched Placebo (PLB) | Total |
|---|---|---|---|
| Female | 31 | 95 | 126 |
| Male | 78 | 199 | 277 |
| Race/Ethnicity, Customized(participants) | Active Medication Combination (AMC) | Matched Placebo (PLB) | Total |
|---|---|---|---|
| Not Hispanic/ Latino | 96 | 249 | 345 |
| Hispanic/Latino | 13 | 42 | 55 |
| Unknown Ethnicity | 0 | 2 | 2 |
| Refused to answer Ethnicity | 0 | 1 | 1 |
| American Indian/Alaska Native | 2 | 4 | 6 |
| Asian | 1 | 10 | 11 |
| Black/ African American | 10 | 38 | 48 |
| Native Hawaiian/ Pacific Islander | 1 | 1 | 2 |
| White | 82 | 205 | 287 |
| Other Race | 6 | 14 | 20 |
| Multiracial | 3 | 13 | 16 |
| Unknown Race | 2 | 8 | 10 |
| Refused to answer Race | 2 | 1 | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data from this study will be available to researchers on the website https://datashare.nida.nih.gov/ after the study is complete and the data is analyzed. This website will not include information that can identify individual study participants.The following information will be posted: Study protocol, reference to study publication of primary outcome, data sets (SAS and ASCII ), annotated case report forms, define file (also known as Data Dictionary), study-specific de-identification notes. Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center