Phase 3
N=403
Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
Methamphetamine Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03078075 ↗Enrolled (actual)
403
Serious AEs
2.0%
Results posted
Mar 2021
Primary outcome: Primary: Number of Participants With Treatment Response During Medication Phase at Stage 1 — 10; 18; 284; 91 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Naltrexone: Vivitrol® (Drug); Placebo (PLB) Injectable (Drug); Bupropion: Wellbutrin XL® (Drug); Placebo (PLB) Oral (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Response During Medication Phase at Stage 1 |
10; 18; 284; 91 | — |
| PRIMARY Number of Participants With Treatment Response During Medication Phase at Stage 2 |
2; 13; 9; 21; 109; 101 | — |
| SECONDARY Treatment Effectiveness Score of Participants at Stage 1 |
5.72; 13.84 | — |
| SECONDARY Treatment Effectiveness Score of Participants at Stage 2 |
7.45; 11.55 | — |
| SECONDARY Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period |
5.10; 11.93; 7.95; 10.20; 29.46; 22.56 | — |
| SECONDARY Mean Maximum Number of Consecutive Visits Negative UDS at Stage 1 |
0.54; 1.37 | — |
| SECONDARY Mean Maximum Number of Consecutive Visits Negative UDS at Stage 2 |
0.61; 1.18; 3.10; 2.63 | — |
| SECONDARY Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 1 |
0.15; 0.56 | — |
| SECONDARY Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 2 |
0.20; 0.50; 1.48; 1.20 | — |
| SECONDARY Mean Change of Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 1 |
14.0; 27.2 | — |
| SECONDARY Mean Change Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 2 |
16; 25.3 | — |
| SECONDARY Mean Change of Methamphetamine Craving at Stage 1 |
-22.33; -29.98 | — |
| SECONDARY Mean Change of Methamphetamine Craving at Stage 2 |
-20.52; -31.79 | — |
| SECONDARY Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1 |
41.89; 41.95; 28.53; 31.47; 41.87; 41.87 | — |
| SECONDARY Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2 |
44.96; 44.95; 30.99; 31.05; 44.9; 44.88 | — |
| SECONDARY Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 1 |
-0.054; -0.016; 0.054; 0.103; -0.064; -0.072 | — |
| SECONDARY Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 2 |
-0.035; -0.035; 0.038; 0.119; -0.057; -0.079 | — |
| SECONDARY Mean Change in Number of Other Substance Use by Self-report at Stage 1 |
0.358; -1.604; -12.642; -55.873 | — |
| SECONDARY Mean Change in Number of Other Substance Use by Self-report at Stage 2 |
1.695; -2.942; -9.925; -58.591 | — |
| SECONDARY Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 1 |
-0.064; -0.072 | — |
| SECONDARY Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 2 |
-0.057; -0.079 | — |
| SECONDARY Mean Change of Depression Symptom Score by PHQ-9 at Stage 1 |
-3.26; -4.78 | — |
| SECONDARY Mean Change of Depression Symptom Score by PHQ-9 at Stage 2 |
-3.66; -4.39 | — |
| SECONDARY Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 1 |
1.013; 1.425; 1.071; 3.785; -1.168; 1.582 | — |
| SECONDARY Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 2 |
0.877; 1.561; 2.035; 2.821; 0.262; 0.152 | — |
| SECONDARY Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 1 |
2.2; 6.5 | — |
| SECONDARY Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 2 |
2.5; 6.2 | — |
| SECONDARY Number of Participants Who Completed the Visit in Week 12 |
106; 103; 28; 78 | — |
| SECONDARY Participant Satisfaction Rating Measured by Study Satisfaction Survey at the End of the 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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03078075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.