Methamphetamine Use DisorderPhase 1/2ADAPTNCT01982643
Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder
A Phase 1/2 study testing naltrexone plus bupropion in people with Methamphetamine Use Disorder, run by Walter Ling at 3 sites in United States.
Trial summary
The aim of this 2-stage, 3-site study is to investigate the effectiveness and safety of a combination of extended-release depot naltrexone plus extended-release bupropion as a potential pharmacotherapy for methamphetamine (MA) 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 plus bupropion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2013to Feb 2015
- Phase
- Phase 1/2
- 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
- Be 18 to 65 years of age;
- Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study;
- Demonstrate understanding of study procedures by correctly answering all questions on the consent competency tool;
- Be interested in reducing or stopping methamphetamine use;
- Meet DSM-5 criteria for severe methamphetamine use disorder;
- Meet subjective and objective methamphetamine use criteria as defined by the protocol;
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- Meet subjective and objective measures of being opioid-free prior to enrollment and medication induction per study medical clinician's determination (including passing a naloxone challenge);
- Agree to use study cellphone to record videos of take-home dosing for transfer to study team.
- If female of childbearing potential, agree to use acceptable birth control methods during participation in the study;
Who cannot join
- Have known allergy or sensitivity to study medications;
- Have a medical history or condition that would make study participation difficult or unsafe;
- Have an acute psychiatric disorder or condition that would make study participation difficult or unsafe;
- Liver function test results greater than 5 times the upper limit of normal or other exclusionary clinical lab test values;
- Recent or ongoing treatment with medications that, in the judgment of the study medical clinician, could interact adversely with study drugs or interfere with study participation;
- Have a current pattern of alcohol, benzodiazepine, or other sedative-hypnotic use, as determined by the study medical clinician, which would preclude safe participation;
- Pending action or situation that might prevent remaining in the area for the duration of the study or prevent participation in study activities
- Be currently pregnant or breastfeeding;
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nexus Recovery Center
Dallas, Texas, 75208
University of Hawaii
Honolulu, Hawaii, 96813
UCLA Integrated Substance Abuse Programs
Los Angeles, California, 90025
About this study
Official title: CTN-0054 Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT) for Methamphetamine Use Disorder
The aim of this 2-stage, 3-site study is to investigate the effectiveness and safety of a combination of extended-release depot naltrexone plus extended-release bupropion as a potential pharmacotherapy for methamphetamine (MA) use disorder.
Read the detailed description
Stage 1 will include 20 individuals with severe stimulant use disorder (methamphetamine type) enrolled across three study sites. Following a maximum 30-day screening period to establish eligibility, participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks. Take-home oral study medication (BRP) will be dispensed weekly for dosing on non-clinic days. Participants will be asked to attend clinic twice weekly for observed BRP dosing, collection of urine samples, assessments, and medical management. Following the 8-week active medication phase, participants will complete a follow-up phase, including a medication taper and post-medication phase follow-up visit during Week 9. If Stage 1 data document success (see criteria below) in at least 3 "responder" study participants, Stage 2 will follow utilizing the same protocol as in Stage 1, to enroll an additional group of 29 participants. Using the same criteria of "responder" success, if the combined stages document success in at least 9 of 49 study participants, the combination medication will be considered to have shown sufficient potential to advance to a large-scale placebo-controlled trial.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- naltrexone plus bupropion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naltrexone plus bupropionDrug
Participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| naltrexone plus bupropion | Experimental | extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®) Receives: Drug: naltrexone plus bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Categorized as "Responders"
Study "Responders" were defined as participants providing six MA-negative urine tests of eight administered in the evaluation period (the last four weeks of the active medication phase), including the last test collected in the final study week of the active medication phase.
Measured: Weeks 4-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionFeb 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine Use DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Ling
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Responsible party
- Sponsor-investigator, Walter Ling, University of California, Los Angeles
- Investigators
- Walter Ling, M.D., Principal investigator, UCLA Integrated Substance Abuse ProgramsLarissa Mooney, M.D., Principal investigator, UCLA Integrated Substance Abuse Programs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982643
- Sponsor's protocol ID
- NIDA-CTN-0054
- Other IDs
- U10DA013045
- Acronym
- ADAPT
- Status last verified
- Mar 2020
- First submitted
- 4 Nov 2013
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Walker R, Hillhouse M, Perrochet B, Sparenborg S, Mooney L, Ling W. Medication Adherence Monitoring Using Smartphone Video Dosing in an Open-label Pilot Study of Monthly Naltrexone Plus Once-daily Bupropion for Methamphetamine Use Disorder: Feasibility and Acceptability. J Addict Med. 2019 Sep/Oct;13(5):372-378. doi: 10.1097/ADM.0000000000000509.
PubMed 30724759
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTN-0054 Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT) for Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT01982643
- Acronym / sponsor ID
- ADAPT / NIDA-CTN-0054
- Conditions
- Methamphetamine Use Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Walter LingUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this 2-stage, 3-site study is to investigate the effectiveness and safety of a combination of extended-release depot naltrexone plus extended-release bupropion as a potential pharmacotherapy for methamphetamine (MA) use disorder.
Detailed description
Stage 1 will include 20 individuals with severe stimulant use disorder (methamphetamine type) enrolled across three study sites. Following a maximum 30-day screening period to establish eligibility, participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks. Take-home oral study medication (BRP) will be dispensed weekly for dosing on non-clinic days. Participants will be asked to attend clinic twice weekly for observed BRP dosing, collection of urine samples, assessments, and medical management. Following the 8-week active medication phase, participants will complete a follow-up phase, including a medication taper and post-medication phase follow-up visit during Week 9. If Stage 1 data document success (see criteria below) in at least 3 "responder" study participants, Stage 2 will follow utilizing the same protocol as in Stage 1, to enroll an additional group of 29 participants. Using the same criteria of "responder" success, if the combined stages document success in at least 9 of 49 study participants, the combination medication will be considered to have shown sufficient potential to advance to a large-scale placebo-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| naltrexone plus bupropion | Experimental | Drug: naltrexone plus bupropionextended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be 18 to 65 years of age;
- Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study;
- Demonstrate understanding of study procedures by correctly answering all questions on the consent competency tool;
- Be interested in reducing or stopping methamphetamine use;
- Meet DSM-5 criteria for severe methamphetamine use disorder;
Key exclusion criteria (8 listed)
- Have known allergy or sensitivity to study medications;
- Have a medical history or condition that would make study participation difficult or unsafe;
- Have an acute psychiatric disorder or condition that would make study participation difficult or unsafe;
- Liver function test results greater than 5 times the upper limit of normal or other exclusionary clinical lab test values;
- Recent or ongoing treatment with medications that, in the judgment of the study medical clinician, could interact adversely with study drugs or interfere with study participation;
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 |
|---|---|---|
| naltrexone plus bupropionParticipants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks. | Drug | naltrexone plus bupropion |
Primary outcome
Participants Categorized as "Responders"
Time frame: Weeks 4-8
Study "Responders" were defined as participants providing six MA-negative urine tests of eight administered in the evaluation period (the last four weeks of the active medication phase), including the last test collected in the final study week of the active medication phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30724759Walker R, Hillhouse M, Perrochet B, Sparenborg S, Mooney L, Ling W. Medication Adherence Monitoring Using Smartphone Video Dosing in an Open-label Pilot Study of Monthly Naltrexone Plus Once-daily Bupropion for Methamphetamine Use Disorder: Feasibility and Acceptability. J Addict Med. 2019 Sep/Oct;13(5):372-378. doi: 10.1097/ADM.0000000000000509.
- NIDA Clinical Trials Network Dissemination LibraryLink provided by the sponsor.
- NIH National Institute on Drug Abuse Clinical Trials NetworkLink provided by the sponsor.
- UCLA Integrated Substance Abuse Programs (ISAP)Link provided by the sponsor.
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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.
Walter Ling, M.D. principal investigator
UCLA Integrated Substance Abuse Programs
Larissa Mooney, M.D. principal investigator
UCLA Integrated Substance Abuse Programs
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing naltrexone plus bupropion in people with Methamphetamine Use Disorder, run by Walter Ling at 3 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 9 inclusion and 8 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 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 23 Mar 2020). 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?
Participants Categorized as "Responders" (time frame: Weeks 4-8). 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 NCT01982643, which also lists 1 linked publication.
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 23 Mar 2020.