Methamphetamine-dependencePhase 2CTN-0110NCT05283304
Monthly Injectable BUP for MA Use Disorder (MURB) Trial
A Phase 2 study testing Buprenorphine injection (BUP-Inj) in people with Methamphetamine-dependence, run by Madhukar H. Trivedi, MD at 6 sites in United States.
Trial summary
This study is a 12-week randomized, double-blind, placebo-controlled trial that will investigate the use of injectable buprenorphine (BUP-Inj) compared to injectable placebo (PBO-Inj) for the treatment of methamphetamine use disorder (MUD) among individuals with mild co-use of opioids. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Methamphetamine-dependence
- What is being tested?
- Buprenorphine injection (BUP-Inj)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 Mar 2023to 19 Nov 2023
- Phase
- Phase 2
- 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
- Study participants must:
- Be 18 to 65 years of age, inclusive;
- Able to understand and speak English or Spanish
- Be interested in reducing or stopping MA use;
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for moderate or severe MUD (4 or more criteria);
- Self-report MA use on 18 or more days in the 30-day period prior to written consent using the TLFB;
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- Provide at least 2 urine samples positive for MA out of a possible 3 tests to occur at clinic visits within a 10-day period with at least 2 days between visits;
- Meet DSM-5 criteria for mild OUD (at least 2 but no more than 3 criteria) prior to randomization OR opioid misuse demonstrated by self-report of opioid use of at least 2 days in the 30-day period prior to written consent using the TLFB;
- Provide a urine drug screen negative for opioids at least once during the screening period and on the day of expected randomization to indicate control over opioid use;
- Have a Clinical Opiate Withdrawal Scale (COWS) score of ≤8 at both a screening visit on which they provide a UDS negative for opioids and on the day of randomization.
- If female, agree to use acceptable methods of contraception and have periodic urine pregnancy testing during participation in the study unless unable to get pregnant;
- Be willing and able to provide consent and comply with all study procedures and medication instructions.
Who cannot join
- Study participants must not:
- Have suicidal or homicidal ideation that requires immediate attention;
- Have evidence of prolongation of the corrected QT interval (QTc) or any other finding on the screening ECG that, in the opinion of the Medical Clinician, would preclude safe participation in the study (e.g., hypokalemia, unstable atrial fibrillation) and be at significant risk for serious cardiac adverse events;
- Have a laboratory value with total bilirubin ≥1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≥3 × ULN, aspartate aminotransferase (AST) ≥5 × ULN, or serum creatinine >2 × ULN;
- Have been in a study of pharmacological or behavioral treatment for addiction within 6 months prior to written study consent (smoking cessation excepted);
- Have taken an investigational drug in another study within 30 days prior to written study consent;
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- Have been prescribed and taken buprenorphine or methadone within 30 days prior to written study consent;
- Be concurrently enrolled in formal behavioral or pharmacological addiction treatment services at the time of written consent;
- Be receiving ongoing treatment of medications that are clinically relevant Cytochrome P450 3A4 (CYP 3A4) or Cytochrome P4502C8 (CYP 2C8) inducers or inhibitors (e.g., rifampicin, azole antifungals, macrolide antibiotics), Class IA antiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone) at the time of randomization that, in the judgment of the Medical Clinician, could interact adversely with study medications or put them at significant risk for development of serotonin syndrome;
- Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the Medical Clinician;
- Have a surgery planned or scheduled, or other treatment that would require the use of opioid-containing medications (e.g., opioid analgesics) during the study period;
- Currently or soon to be in jail or prison; currently in any inpatient overnight facility as required by court of law or have pending legal action or other situation that could prevent participation in the study or in any study activities;
- If biologically female, be currently pregnant, breastfeeding, or planning on conception;
- Hypersensitivity (e.g., anaphylaxis) to buprenorphine or any component of the ATRIGEL formulation or their excipients;
- Have an abdominal area unsuitable for subcutaneous injections by the judgment of the Medical Clinician;
- Have other medical, psychiatric or other factors that in the judgment of the Medical Clinician could make participation difficult or unsafe.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
UTSW Medical Center, Center for Depression Research and Clinical Care
Dallas, Texas, 75247
UCLA Vine Street Clinic
Los Angeles, California, 90038
Highland Hospital, Alameda Health System
Oakland, California, 94602
CODA
Portland, Oregon, 97214
University of Washington Medicine-Harborview Medical Center
Seattle, Washington, 98104
Oklahoma State University, Center for Health Sciences
Tulsa, Oklahoma, 74107
About this study
Official title: Randomized, Double-blind, Placebo-controlled Trial of Monthly Injectable Buprenorphine (BUP) for Methamphetamine (MA) Use Disorder
This study is a 12-week randomized, double-blind, placebo-controlled trial that will investigate the use of injectable buprenorphine (BUP-Inj) compared to injectable placebo (PBO-Inj) for the treatment of methamphetamine use disorder (MUD) among individuals with mild co-use of opioids.
Read the detailed description
Primary Objective: To evaluate whether assignment to 12 weeks of outpatient BUP-Inj compared to 12 weeks of outpatient PBO-Inj reduces MA use (as measured by twice-weekly urine drug screens (UDS)) during Weeks 9-12 in participants with moderate to severe MUD with co-occurring mild opioid use disorder (OUD) or opioid misuse not warranting medication for opioid use disorder (MOUD).
Secondary Objectives: To evaluate whether assignment to 12 weeks of outpatient BUP-Inj compared to 12 weeks of outpatient PBO-Inj among participants with moderate to severe MUD with co-occurring mild OUD or opioid misuse not warranting MOUD improves: 1) outcomes related to alternate measures of MA use including total number of MA negative urine drug screens (UDS) during study and self-reported days of MA use; 2) measures of opioid use and self-reported frequency of opioid use; and 3) measures of MA and opioid co-use and self-reported days of MA and opioid co-use.
- Conditions
- Methamphetamine-dependence
- Being tested
- Buprenorphine injection (BUP-Inj), Placebo injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine injection (BUP-Inj)Drug
Also called SublocadeTM, Indivior
Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
Placebo injectionOther
Also called Placebo injection (PBO-Inj)
Sublingual buprenorphine induction, then Placebo injectable (300 mg)
| Study group | Role | What they receive |
|---|---|---|
| Injectable Buprenorphine (BUP-inj) | Experimental | Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks Receives: Drug: Buprenorphine injection (BUP-Inj) |
| Injectable Placebo (PBO-inj) | Placebo comparator | Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks. Receives: Other: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Methamphetamine-negative Urine Samples
Number of Methamphetamine (MA)-negative Urine Drug Screen (UDS) results obtained during Weeks 9 through 12 of the medication phase is measured for the BUP-Inj and PBO-Inj conditions. Number of UDS results / number of expected UDS results. Two UDS results were expected each week.
Measured: weeks 9-12
Secondary outcomes (6)
Treatment Effective Score (TES) for MA-negative UDS Results
The TES is defined to be the number of MA negative UDS divided by the number of possible UDS collected during the study. In this study there are 24 possible UDS collections so the number of MA negative UDS is divided by 24. Possible score ranges from 0-24; with higher score indicating better outcome.
Measured: weeks 1-12
Number of Days of Methamphetamine Use During the Medication Phase
Number of days of methamphetamine use during treatment will be measured using Timeline Followback (TLFB) procedure which will be administered to document the participant's self-reported use during Weeks 1-12. Possible scores range from 0-84, with lower scores indicating better outcome.
Measured: weeks 1-12
Treatment Effective Score (TES) for Opioid Negative UDS Results
The TES is defined to be the number of UDS results negative for opioids divided by the number of possible UDS collected during the study. In this study there are 24 possible UDS collections, so the number of opioid negative UDS is divided by 24. Possible score ranges from 0-24; with higher score indicating better outcome.
Measured: weeks 1-12
Number of Days of Opioid Use During the Medication Phase
Number of days of opioid use during treatment will be measured using Timeline Followback (TLFB) procedure which will be administered to document the participant's self-reported opioid use at week 12. Possible scores range from 0-84, with lower scores indicating better outcome.
Measured: weeks 1-12
Treatment Effective Score (TES) for MA and Opioid Co-Use Compiled
The TES is defined to be the number of MA and Opioid Co-Use negative UDS divided by the number of possible UDS collected during the study. In this study there are 24 possible UDS collections, so the number of MA and Opioid Co-Use negative UDS is divided by 24. Possible score ranges from 0-24; with higher score indicating better outcome.
Measured: weeks 1-12
Number of Days of MA and Opioid Co-use During the Medication Phase
Number of days of MA and opioid co-use during treatment will be measured using Timeline Followback (TLFB) procedure which will be administered to document the participant's self-reported use of substances for each day at week 12. Possible scores range from 0-84, with lower scores indicating better outcome.
Measured: weeks 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start24 Mar 2023
- Primary completion20 Oct 2023
- Study completion19 Nov 2023
Why it stopped: Side effects of medication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Methamphetamine-dependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madhukar H. Trivedi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar Trivedi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283304
- Sponsor's protocol ID
- NIDA CTN Protocol 0110
- Acronym
- CTN-0110
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2022
- Last updated
- 21 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 National Institute on Drug Abuse (NIDA) Data Share Agreement.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial of Monthly Injectable Buprenorphine (BUP) for Methamphetamine (MA) Use Disorder
- ClinicalTrials.gov ID
- NCT05283304
- Acronym / sponsor ID
- CTN-0110 / NIDA CTN Protocol 0110
- Conditions
- Methamphetamine-dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Side effects of medication
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Madhukar H. Trivedi, MDUniversity, hospital or other
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 19 Nov 2023 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 12-week randomized, double-blind, placebo-controlled trial that will investigate the use of injectable buprenorphine (BUP-Inj) compared to injectable placebo (PBO-Inj) for the treatment of methamphetamine use disorder (MUD) among individuals with mild co-use of opioids.
Detailed description
Primary Objective: To evaluate whether assignment to 12 weeks of outpatient BUP-Inj compared to 12 weeks of outpatient PBO-Inj reduces MA use (as measured by twice-weekly urine drug screens (UDS)) during Weeks 9-12 in participants with moderate to severe MUD with co-occurring mild opioid use disorder (OUD) or opioid misuse not warranting medication for opioid use disorder (MOUD).
Secondary Objectives: To evaluate whether assignment to 12 weeks of outpatient BUP-Inj compared to 12 weeks of outpatient PBO-Inj among participants with moderate to severe MUD with co-occurring mild OUD or opioid misuse not warranting MOUD improves: 1) outcomes related to alternate measures of MA use including total number of MA negative urine drug screens (UDS) during study and self-reported days of MA use; 2) measures of opioid use and self-reported frequency of opioid use; and 3) measures of MA and opioid co-use and self-reported days of MA and opioid co-use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injectable Buprenorphine (BUP-inj) | Experimental | Drug: Buprenorphine injection (BUP-Inj)Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks |
| Injectable Placebo (PBO-inj) | Placebo comparator | Other: Placebo injectionFollowing successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Study participants must:
Key exclusion criteria (16 listed)
- Study participants must not:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine injection (BUP-Inj)Also: SublocadeTM, IndiviorSublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg) | Drug | Injectable Buprenorphine (BUP-inj) |
| Placebo injectionAlso: Placebo injection (PBO-Inj)Sublingual buprenorphine induction, then Placebo injectable (300 mg) | Other | Injectable Placebo (PBO-inj) |
Primary outcome
Number of Methamphetamine-negative Urine Samples
Time frame: weeks 9-12
Number of Methamphetamine (MA)-negative Urine Drug Screen (UDS) results obtained during Weeks 9 through 12 of the medication phase is measured for the BUP-Inj and PBO-Inj conditions. Number of UDS results / number of expected UDS results. Two UDS results were expected each week.
6 secondary outcomes
Treatment Effective Score (TES) for MA-negative UDS Results
Time frame: weeks 1-12
Number of Days of Methamphetamine Use During the Medication Phase
Time frame: weeks 1-12
Treatment Effective Score (TES) for Opioid Negative UDS Results
Time frame: weeks 1-12
Number of Days of Opioid Use During the Medication Phase
Time frame: weeks 1-12
Treatment Effective Score (TES) for MA and Opioid Co-Use Compiled
Time frame: weeks 1-12
Number of Days of MA and Opioid Co-use During the Medication Phase
Time frame: weeks 1-12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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 National Institute on Drug Abuse (NIDA) Data Share Agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhukar Trivedi, MD principal investigator
University of Texas Southwestern Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buprenorphine injection (BUP-Inj) in people with Methamphetamine-dependence, run by Madhukar H. Trivedi, MD at 6 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 12 inclusion and 16 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: stopped early, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 21 Mar 2025). 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 Methamphetamine-negative Urine Samples (time frame: weeks 9-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2025.