Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03078075 · ClinicalTrials.gov registry record · Phase 3
Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
A Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 403
- Enrollment target
NCT03078075: Completed Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
NCT03078075 is a Phase 3 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 403 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03078075, a Phase 3 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 403 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG Naltrexone: Vivitrol®
- DRUG Placebo (PLB) Injectable
- DRUG Bupropion: Wellbutrin XL®
- DRUG Placebo (PLB) Oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 403 participants |
| Start Date | 2017-05-05 |
| Est. Completion | 2019-07-25 |
| Phase | Phase 3 |
What the finished NCT03078075 record still lists
NCT03078075 is an interventional study that assigns participants to a tested intervention. The registered 403 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 4 interventions - of which Naltrexone: Vivitrol® is the first listed.
NCT03078075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03078075 about?
NCT03078075 is a clinical study titled "Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder". 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 ma...
What is the current status of trial NCT03078075?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 403 participants. The study started on 2017-05-05. Estimated completion is 2019-07-25.
What interventions are being tested in trial NCT03078075?
The interventions under investigation include: Naltrexone: Vivitrol® (DRUG), Placebo (PLB) Injectable (DRUG), Bupropion: Wellbutrin XL® (DRUG), Placebo (PLB) Oral (DRUG).
Who is sponsoring clinical trial NCT03078075?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03078075's enrollment target sits among peer trials
403 917th of 2000 higher than 1,082 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05647122 · 403 participants · Phase 1
First in Human Study of AZD9592 in Solid Tumors
- NCT05674799 · 403 participants · NA
NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
- NCT06244771 · 403 participants · Phase 1
A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
- NCT05049057 · 404 participants · Phase 2
Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI