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Methamphetamine Use DisorderPhase 3ADAPT-2NCT03078075

Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder

A Phase 3 study testing Naltrexone: Vivitrol® and Bupropion: Wellbutrin XL® in people with Methamphetamine Use Disorder, run by University of Texas Southwestern Medical Center at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Methamphetamine Use Disorder
What is being tested?
Naltrexone: Vivitrol® and Bupropion: Wellbutrin XL®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
403 participants
Where
8 sitesUnited States
Study dates
5 May 2017to 25 Jul 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235

  • University of Texas Health Science Center - Center for Neurobehavioral Research on Addiction (CNRA)

    Houston, Texas, 77054

  • University of California Los Angeles (UCLA) Center for Behavioral Addiction Medicine (CBAM)

    Los Angeles, California, 90038

  • Hennepin County Medical Center- Berman Center for Research

    Minneapolis, Minnesota, 55415

  • New York State Psychiatric Institute (NYSPI)- Substance Use Research Center (SURC)

    New York, New York, 10032

  • Behavioral Health Services (BHS) of Pickens County

    Pickens, South Carolina, 29671

  • CODA, Inc.

    Portland, Oregon, 97214

  • Substance Use Research Unit (SURU) at the San Francisco Dept. of Public Health

    San Francisco, California, 94102

Other trials in United States

About this study

Official title: NIDA (National Institute on Drug Abuse) CTN (Clinical Trials Network) Protocol 0068: 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 matching placebo group and will receive medications over the course of 12 weeks. Follow-ups will occur in weeks 13 and 16.

Read the detailed description

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.

Being tested
Naltrexone: Vivitrol®, Placebo (PLB) Injectable, Bupropion: Wellbutrin XL®, Placebo (PLB) Oral
Keywords
Methamphetamine, Methamphetamine Use Disorder, Naltrexone, Bupropion, Vivitrol®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naltrexone: Vivitrol®Drug

    Also called Arm: Experimental - Active Medication Combination (AMC)

    Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks

  • Placebo (PLB) InjectableDrug

    Also called Injectable matching (to Naltrexone) placebo, Arm: Placebo Comparator - matched Placebo (PLB)

    Placebo: 4 intramuscular injections administered every 3 weeks

  • Bupropion: Wellbutrin XL®Drug

    Also called Arm: Experimental - Active Medication Combination (AMC)

    Bupropion: 450 mg oral dose daily

  • Placebo (PLB) OralDrug

    Also called Oral matching (to Bupropion) placebo tablets, Arm: Placebo Comparator - matched Placebo (PLB)

    Placebo: once-daily oral placebo tablets

Study groups in NCT03078075
Study groupRoleWhat they receive
Active Medication Combination (AMC)Experimentalinjectable extended release naltrexone plus once daily oral extended-release bupropion tablets
Receives: Drug: Naltrexone: Vivitrol®; Drug: Bupropion: Wellbutrin XL®
Matched Placebo (PLB)Placebo comparatorinjectable matching placebo plus once-daily oral placebo tablets
Receives: Drug: Placebo (PLB) Injectable; Drug: Placebo (PLB) Oral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Response During Medication Phase at Stage 1

    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.

    Measured: At week 6

  2. Number of Participants in Placebo Arm 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 drug screens (UDS) at the end of stage 2 (weeks 11-12).

    Non-Responder: All other participants without 3 or 4 methamphetamine-negative UDS.

    Measured: At week 12

  3. Number of Participants With Treatment Response During Medication Phase at Stage 1 (by Race)

    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

    Measured: At week 6

  4. Number of Participants With Treatment Response During Medication Phase at Stage 1 (by Ethnicity)

    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

    Measured: At Week 6

  5. Number of Participants With Treatment Response During Medication Phase at Stage 1 (by Sex)

    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

    Measured: At week 6

  6. Number of Participants With Treatment Response During Medication Phase at Stage 2 (by Race)

    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

    Measured: At week 12

  7. Number of Participants With Treatment Response During Medication Phase at Stage 2 (by Ethnicity)

    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

    Measured: at Week 12

  8. Number of Participants With Treatment Response During Medication Phase at Stage 2 (by Sex)

    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

    Measured: At week 12

Secondary outcomes (27)

  1. 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.

    Measured: At weeks 6

  2. 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.

    Measured: At week 12

  3. 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 )

    Measured: Weeks 1-4 and Weeks 7-10

  4. 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.

    Measured: At week 6

  5. 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.

    Measured: At week 12

  6. 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.

    Measured: At week 6

  7. 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.

    Measured: At week12

  8. 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.

    Measured: Baseline, week 6

  9. 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.

    Measured: week 7, week 12

  10. 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.

    Measured: Baseline, week 6

  11. 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.

    Measured: week 7, week 12

  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.

    Measured: At week 6

  13. 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.

    Measured: at week 12

  14. 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.

    Measured: Baseline, week 6

  15. 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.

    Measured: week 7, week 12

  16. 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.

    Measured: Baseline, week 6

  17. 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.

    Measured: week 7, week 12

  18. 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.

    Measured: Baseline, week 6

  19. 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.

    Measured: week 7, week 12

  20. 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)

    Measured: Baseline, week 6

  21. 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)

    Measured: week 7, week 12

  22. 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.

    Measured: Baseline, Week 6

  23. 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.

    Measured: week 7, week 12

  24. 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.

    Measured: Baseline, week 6

  25. 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.

    Measured: week 7, week 12

  26. Number of Participants Who Completed the Visit in Week 12

    The number of participants in Stage 2 who completed the Week 12 visit.

    Measured: At week 12

  27. Participant Satisfaction Rating Measured by Study Satisfaction Survey at the End of the Study

    The Study satisfaction survey measures the satisfaction with their study experience for participants who completed the Week 12 visit.. Ratings were:

    1. Very Dissatisfied
    2. Dissatisfied
    3. Neither
    4. Satisfied
    5. Very Satisfied

    Measured: At week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2017
  2. Study start5 May 2017
  3. Primary completion3 Jul 2019
  4. Study completion25 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
During the study, participants may or may not be switched to another group due to the adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
403 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03078075
Sponsor's protocol ID
CTN-0068
Other IDs
UG1DA020024
Acronym
ADAPT-2
Status last verified
Oct 2026
First submitted
2 Mar 2017
Last updated
27 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Trivedi MH, Walker R, Ling W, Dela Cruz A, Sharma G, Carmody T, Ghitza UE, Wahle A, Kim M, Shores-Wilson K, Sparenborg S, Coffin P, Schmitz J, Wiest K, Bart G, Sonne SC, Wakhlu S, Rush AJ, Nunes EV, Shoptaw S. Bupropion and Naltrexone in Methamphetamine Use Disorder. N Engl J Med. 2021 Jan 14;384(2):140-153. doi: 10.1056/NEJMoa2020214.

    PubMed 33497547

  • Mojtabai R, Susukida R, Farokhnia M, Nguyen TQ, Leggio L, Bergeria C, Prasad S, Dunn KE, Amin-Esmaeili M. Mediators of treatment response in a clinical trial of naltrexone and bupropion for methamphetamine use disorder: A longitudinal mediation analysis. J Psychopharmacol. 2026 Jul 26:2698811261464533. doi: 10.1177/02698811261464533. Online ahead of print.

    PubMed 42504048

  • Mojtabai R, Susukida R, Farokhnia M, Nguyen TQ, Leggio L, Bergeria C, Prasad S, Dunn KE, Amin-Esmaeili M. Mediators of Treatment Response in Clinical Trial of Naltrexone and Bupropion for Methamphetamine Use Disorder: A Longitudinal Mediation Analysis. medRxiv [Preprint]. 2026 May 13:2026.05.09.26352807. doi: 10.64898/2026.05.09.26352807.

    PubMed 42180350

  • Jha MK, Ghitza UE, Shoptaw S, Minhajuddin A, Kuruvila S, Wakhlu S, Nunes EV, Schmitz J, Coffin PO, Bart G, Carmody T, Trivedi MH. Early Change in Depressive Symptom Severity With Naltrexone-Bupropion Combination and Its Association With Reduction in Methamphetamine Use in ADAPT-2 Trial. J Clin Psychiatry. 2025 Jul 30;86(3):25m15825. doi: 10.4088/JCP.25m15825.

    PubMed 40767786

  • Jha MK, Ghitza UE, Carmody T, Kuruvila S, Shoptaw S, Minhajuddin A, Wakhlu S, Schmitz JM, Coffin PO, Bart G, Nunes EV, Kenny P, Trivedi MH. Craving, Impulsivity, and Subsequent Methamphetamine Use With Naltrexone-Bupropion Versus Placebo: Findings From a Randomized Clinical Trial. J Addict Med. 2026 Mar-Apr 01;20(2):214-222. doi: 10.1097/ADM.0000000000001538. Epub 2025 Jul 7.

    PubMed 40623319

  • Li MJ, Chau B, Belin T, Carmody T, Jha MK, Marino EN, Trivedi M, Shoptaw SJ. Extended observation of reduced methamphetamine use with combined naltrexone plus bupropion in the ADAPT-2 trial. Addiction. 2024 Oct;119(10):1840-1845. doi: 10.1111/add.16529. Epub 2024 Jun 10.

    PubMed 38856086

  • Okafor CN, Carmody T, Stotts AL, Bart G, Mayes TL, Karns-Wright T, Trivedi M, Shoptaw S, Potter JS. Sociodemographic and patient reported outcomes by racial and ethnicity status among participants in a randomized controlled trial for methamphetamine use disorder. Drug Alcohol Depend Rep. 2024 Apr 6;11:100230. doi: 10.1016/j.dadr.2024.100230. eCollection 2024 Jun.

    PubMed 38665252

  • Trombello JM, Kulikova A, Mayes TL, Nandy K, Carmody T, Bart G, Nunes EV, Schmitz J, Kalmin M, Shoptaw S, Trivedi MH. Psychometrics of the Concise Health Risk Tracking Self-Report (CHRT-SR16) Assessment of Suicidality in a Sample of Adults with Moderate to Severe Methamphetamine Use Disorder: Findings from the ADAPT-2 Randomized Trial. Neuropsychiatr Dis Treat. 2023 Jun 22;19:1443-1454. doi: 10.2147/NDT.S406909. eCollection 2023.

    PubMed 37377462

  • Vo HT, Kulikova A, Mayes TL, Carmody T, Shoptaw S, Ling W, Trombello JM, Trivedi MH. Psychometric properties of the Treatment Effectiveness Assessment in methamphetamine use disorder. J Subst Use Addict Treat. 2023 Aug;151:209085. doi: 10.1016/j.josat.2023.209085. Epub 2023 May 26.

    PubMed 37245855

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Naltrexone: Vivitrol® and Bupropion: Wellbutrin XL® in people with Methamphetamine Use Disorder, run by University of Texas Southwestern Medical Center at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Response During Medication Phase at Stage 1 (time frame: At week 6). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03078075, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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