Trial · NCT03078075
Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
NCT03078075, Phase 3, Completed, University of Texas Southwestern Medical Center; results first posted 2021-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder. Trials, record NCT03078075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03078075
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
- NCT number
- NCT03078075
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 403 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Methamphetamine Use Disorder
- Interventions
- Naltrexone: Vivitrol®, Placebo (PLB) Injectable, Bupropion: Wellbutrin XL®, Placebo (PLB) Oral
- First posted
- 2017-03-13
- Last updated
- 2026-10-27
- Results first posted
- 2021-03-29
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Response During Medication Phase at Stage 1 | At weeks 6 | Intention to treat analysis was done including drop-out | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Response During Medication Phase at Stage 2 | At week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Treatment Effectiveness Score of Participants at Stage 1 | At weeks 6 | Intention to treat analysis was done including drop-out | percentage of urine drug screens | MEAN |
| SECONDARY | Treatment Effectiveness Score of Participants at Stage 2 | At week 12 | As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC) | percentage of urine drug screens | MEAN |
| SECONDARY | Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period | Weeks 1-4 and Weeks 7-10 | Intention to treat analysis was done including drop-out. | percentage of participants | NUMBER |
| SECONDARY | Mean Maximum Number of Consecutive Visits Negative UDS at Stage 1 | At week 6 | UDS test results | MEAN | |
| SECONDARY | Mean Maximum Number of Consecutive Visits Negative UDS at Stage 2 | Stage 2 evaluation period at Weeks 12 | UDS test results | MEAN | |
| SECONDARY | Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 1 | At week 6 | weeks | MEAN | |
| SECONDARY | Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 2 | At week12 | weeks | MEAN | |
| SECONDARY | Mean Change of Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 1 | Baseline, week 6 | percentage of abstinent days | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Response During Medication Phase at Stage 1 | Stage 1 Placebo | Responders (Methamphetamine negative UDS results) | 10 | Participants | |
| Number of Participants With Treatment Response During Medication Phase at Stage 1 | Stage 1 AMC | Responders (Methamphetamine negative UDS results) | 18 | Participants | |
| Number of Participants With Treatment Response During Medication Phase at Stage 1 | Stage 1 Placebo | Non-responders (Methamphetamine positive UDS results) | 284 | Participants | |
| Number of Participants With Treatment Response During Medication Phase at Stage 1 | Stage 1 AMC | Non-responders (Methamphetamine positive UDS results) | 91 | Participants | |
| Number of Participants With Treatment Response During Medication Phase at Stage 2 | Stage 2 Re-Randomized Placebo | Responders (Methamphetamine negative UDS results) | 2 | Participants | |
| Number of Participants With Treatment Response During Medication Phase at Stage 2 | Stage 2 Re-Randomized AMC | Responders (Methamphetamine negative UDS results) | 13 | Participants | |
| Number of Participants With Treatment Response During Medication Phase at Stage 2 | Stage 2 Not Re-Randomized Placebo | Responders (Methamphetamine negative UDS results) | 9 | Participants | |
| Number of Participants With Treatment Response During Medication Phase at Stage 2 | Stage 2 Not Re-Randomized AMC | Responders (Methamphetamine negative UDS results) | 21 | Participants | |
| Number of Participants With Treatment Response During Medication Phase at Stage 2 | Stage 2 Re-Randomized Placebo | Non-Responders (Methamphetamine positive UDS results) | 109 | Participants | |
| Number of Participants With Treatment Response During Medication Phase at Stage 2 | Stage 2 Re-Randomized AMC | Non-Responders (Methamphetamine positive UDS results) | 101 | Participants |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stage 1 Placebo Non-responders Re-randomized to Placebo at Stage 2 | 111 | |
| Overall Study | STARTED | Stage 1 Placebo Non-responders Re-randomized to AMC at Stage 2 | 114 | |
| Overall Study | STARTED | Stage 1 Placebo Non-responders Not Re-randomized at Stage 2 | 59 | |
| Overall Study | STARTED | Stage 1 Placebo Responders Not Re-randomized at Stage 2 | 10 | |
| Overall Study | STARTED | Stage 1 AMC Remaining on AMC at Stage 2 | 109 | |
| Overall Study | COMPLETED | Stage 1 Placebo Non-responders Re-randomized to Placebo at Stage 2 | 106 | |
| Overall Study | COMPLETED | Stage 1 Placebo Non-responders Re-randomized to AMC at Stage 2 | 103 | |
| Overall Study | COMPLETED | Stage 1 Placebo Non-responders Not Re-randomized at Stage 2 | 19 | |
| Overall Study | COMPLETED | Stage 1 Placebo Responders Not Re-randomized at Stage 2 | 9 | |
| Overall Study | COMPLETED | Stage 1 AMC Remaining on AMC at Stage 2 | 78 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Stage 1 Placebo | 45 | 294 | |
| other | Nausea | Gastrointestinal disorders | Stage 1 AMC | 41 | 109 | |
| other | Nausea | Gastrointestinal disorders | Stage 2 Re-Randomized Placebo | 8 | 111 | |
| other | Nausea | Gastrointestinal disorders | Stage 2 Re-Randomized AMC | 32 | 114 | |
| other | Nausea | Gastrointestinal disorders | Stage 2 Not Re-Randomized Placebo | 0 | 69 | |
| other | Nausea | Gastrointestinal disorders | Stage 2 Not Re-Randomized AMC | 6 | 109 | |
| serious | Seizure | Nervous system disorders | Stage 1 Placebo | 1 | 294 | 1 |
| serious | Seizure | Nervous system disorders | Stage 1 AMC | 0 | 109 | 0 |
| serious | Seizure | Nervous system disorders | Stage 2 Re-Randomized Placebo | 0 | 111 | 0 |
| serious | Seizure | Nervous system disorders | Stage 2 Re-Randomized AMC | 0 | 114 | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1 Placebo | 0 | 294 |
| Total, all-cause mortality | Stage 1 AMC | 0 | 109 |
| Total, all-cause mortality | Stage 2 Re-Randomized Placebo | 0 | 111 |
| Total, all-cause mortality | Stage 2 Re-Randomized AMC | 0 | 114 |
| Total, all-cause mortality | Stage 2 Not Re-Randomized Placebo | 0 | 69 |
| Total, all-cause mortality | Stage 2 Not Re-Randomized AMC | 0 | 109 |
| Total, other adverse events | Stage 1 Placebo | 45 | 294 |
| Total, other adverse events | Stage 1 AMC | 41 | 109 |
| Total, other adverse events | Stage 2 Re-Randomized Placebo | 8 | 111 |
| Total, other adverse events | Stage 2 Re-Randomized AMC | 32 | 114 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers9
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UG1DA020024 | NIDA Clinical Trials Network: Big South/West Node | TRIVEDI, MADHUKAR H.; SHOPTAW, STEVEN J | UT SOUTHWESTERN MEDICAL CENTER | NATIONAL INSTITUTE ON DRUG ABUSE | 2015 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03078075
GET https://conductscience.org/api/trials/v1/NCT03078075/registered?page=2