Trial · NCT03078075
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Response During Medication Phase at Stage 1 | At week 6 | Treatment response is defined as 'Responder' and 'Non-Responder'. Responder : Participant who meets 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 urine drug test. |
| Primary | Number of Participants in Placebo Arm 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 drug screens (UDS) at the end of stage 2 (weeks 11-12). Non-Responder: All other participants without 3 or 4 methamphetamine-negative UDS. |
| Primary | Number of Participants With Treatment Response During Medication Phase at Stage 1 (by Race) | At week 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). Race: Black, White, Other |
| Primary | Number of Participants With Treatment Response During Medication Phase at Stage 1 (by Ethnicity) | At Week 6 | Treatment response is defined as 'Responder' and 'Non-Responder'. Responder : Participant who meets 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). Ethnicity: Hispanic, Non-Hispanic/Other |
| Primary | Number of Participants With Treatment Response During Medication Phase at Stage 1 (by Sex) | At week 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). Sex: Female, Male |
| Primary | Number of Participants With Treatment Response During Medication Phase at Stage 2 (by Race) | 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 2 (weeks 11-12). Non-Responder: All other participants without 3 or 4 methamphetamine-negative UDS (Urine Drug Screen). Race: Black, White, Other |
| Primary | Number of Participants With Treatment Response During Medication Phase at Stage 2 (by Ethnicity) | at Week 12 | Treatment response is defined as 'Responder' and 'Non-Responder'. Responder : Participant who meets responder criterion by providing at least 3 out of a possible 4 methamphetamine negative urine tests at the end of stage 2 (weeks 11-12). Non-Responder: All other participants without 3 or 4 methamphetamine-negative UDS (Urine Drug Screen). Ethnicity: Hispanic, Non-Hispanic/Other |
| Primary | Number of Participants With Treatment Response During Medication Phase at Stage 2 (by Sex) | 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 2 (weeks 11-12). Non-Responder: All other participants without 3 or 4 methamphetamine-negative UDS (Urine Drug Screen). Sex: Female, Male |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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 ) |
| Secondary | 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. |
| Secondary | Mean Maximum Number of Consecutive Visits Negative UDS at Stage 2 | At week 12 | Measured by maximum consecutive negative UDS: Count the number and range 0-12 and report the maximum number. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03078075/registered