Methamphetamine Use DisorderPhase 1POMA-MA-Ph1NCT03106571
Study of Pomaglumetad and Methamphetamine
A Phase 1 study testing Pomaglumetad methionil and Methamphetamine in people with Methamphetamine Use Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This is the first study of pomaglumetad in humans using methamphetamine. The goal of the study is to determine if pomaglumetad is safe when administered with methamphetamine. If shown to be safe with methamphetamine in the current study, a phase 2 clinical trial of pomaglumetad would be done to begin to find out if… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Pomaglumetad methionil and Methamphetamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 31 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- not seeking treatment for MA problems at the time of the study;
- English-speaking;
- age 18-55 years inclusive;
- meet DSM-5 criteria for MA use disorder, moderate-severe as diagnosed via MINI;
- have a self-reported history of using MA either via injection or smoking and provide at least one MA-positive urine prior to admission;
- provide a urine drug screen negative for all illicit drugs, excepting THC, on the day of scheduled inpatient admission;
Show all 14Show fewer
- report methamphetamine use on 10 or more days in the past 30 days at baseline;
- have a resting heart rate ≤ 100 bpm, systolic blood pressure ≤ 160 mm Hg, and diastolic blood pressure ≤ 100 mm Hg prior to admission;
- have a baseline EKG that demonstrates normal sinus rhythm, QTc ≤ 450 msec in men or QTc ≤ 460 msec in women, and no clinically significant arrhythmias;
- if female (except females of non-childbearing potential-e.g., at least 1 year post-menopausal or surgically sterile), not pregnant confirmed by negative pregnancy test nor lactating and willing to use a medically approved method of birth control to prevent pregnancy during the trial and for 40 days after the last dose of study medication;
- if male, willing to refrain from donating sperm during the study and for 100 days following the last dose of study medication and agree that they and their partners will use a medically approved contraceptive method;
- have a medical history and physical/neurological examination demonstrating no additional clinically significant contraindications for study participation, in the judgment of the investigators;
- able to participate in all scheduled evaluations, likely to complete all scheduled tests, and likely to be adherent, in the opinion of the investigator and;
- agree not to post any personal medical data or information related to the study on any social media site or website until the trial has completed.
Who cannot join
- non-English speaking;
- currently on probation or parole;
- have current cocaine, opioid, marijuana, or alcohol use disorder, moderate-severe;
- have liver function tests (total bilirubin, ALT, AST, or alkaline phosphatase) ≥ 2 x the upper limit of normal or kidney function tests (creatinine and BUN) ≥ 2 x the upper limit of normal;
- current or past history of seizure disorder;
- a history of head trauma that resulted in neurological sequelae;
Show all 18Show fewer
- major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar illness but excepting stable major depressive disorder, generalized anxiety disorder, etc.) as assessed by the MINI;
- have a current neurological disorder (e.g., organic brain disease, dementia) or medical condition which would make study compliance difficult or compromise informed consent;
- current ongoing treatment with psychotropic medications (e.g. antidepressants, antipsychotics, antiepileptics, sedative/hypnotics, narcotic analgesics);
- history of suicide attempt(s) in the past 6 months or active suicidal intention or plan (score 4 or 5) in the past month as assessed by the C-SSRS;
- evidence of clinically significant heart disease or hypertension;
- evidence of untreated or unstable serious medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease including active tuberculosis infection;
- have HIV infection and currently symptomatic, have a diagnosis of AIDS, or are receiving antiretroviral medication;
- have a medical condition that makes maintaining reliable intravenous access impossible;
- donated blood or plasma within 3 months of inpatient admission;
- use of OAT1 inhibitor (e.g. probenecid, uricosurics, antivirals, nonsteroidal anti-inflammatories, loop diuretics, angiotensin II receptor antagonists, proton pump inhibitors, or statins) or CYP2D6 inducers or inhibitors within 14 days or five half-lives, whichever is longer, from admission;
- currently employed by UCLA or Denovo or a first-degree relative of UCLA or Denovo employee or;
- any other circumstances that, in the opinion of the investigators, would compromise participant safety and/or successful completion of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Safety-interaction Study of Pomaglumetad Methionil for Methamphetamine Use Disorder
This is the first study of pomaglumetad in humans using methamphetamine. The goal of the study is to determine if pomaglumetad is safe when administered with methamphetamine. If shown to be safe with methamphetamine in the current study, a phase 2 clinical trial of pomaglumetad would be done to begin to find out if pomaglumetad is effective in treating methamphetamine use disorder.
Read the detailed description
The study design is a randomized, double-blind, placebo-controlled multiple ascending-dose study of pomaglumetad in 24 non-treatment seeking participants with methamphetamine use disorder. Three cohorts of 8 participants each (total N = 24) will be enrolled and within each cohort participants will be randomly assigned in a 6:2 ratio to undergo methamphetamine infusions and assessments during treatment with pomaglumetad (N = 6 per cohort) or placebo (N = 2 per cohort). Participants in cohort 1 will receive pomaglumetad 40 mg orally twice daily (BID) or placebo, cohort 2 will receive pomaglumetad 80 mg BID or placebo, and cohort 3 will receive pomaglumetad 160 mg BID or placebo.
After completing outpatient baseline and screening/eligibility assessments, eligible participants will be admitted to the UCLA Hospital and will remain hospitalized during all experimental procedures (approximately 11 days and 10 nights).
A urine drug toxicology screen free of illicit substances (with the exception of THC) is required for admission. Upon admission, participants will receive a sample/test infusion of MA 30 mg IV. Participants tolerating the test infusion (no serious adverse advents and not exceeding stopping criteria below) will be randomized to receive POMA (40 mg BID in cohort 1, 80 mg BID in cohort 2, and 160 mg BID in cohort 3) or placebo.
Following three days of MA abstinence and POMA/placebo dosing to achieve study medication steady-state, participants will complete a MA self-administration session.
After two days for MA washout, participants will then have serial plasma samples collected over 12 hours to assess PK for POMA. The next day, participants will receive a 30 mg MA infusion followed by serial plasma sample collection over the following 48 hours for MA PK analysis.
Measures of cardiovascular response, subjective effects, and adverse events will be assessed following all MA infusions during self-administration and PK sessions.
Upon completion of the PK sample collection, participants will be discharged and a 14-day post-discharge (± 7 days) follow-up outpatient visit will be completed for safety purposes.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Pomaglumetad methionil, Placebo, Methamphetamine
- Keywords
- Phase 1 clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomaglumetad methionilDrug
Tablets twice daily
PlaceboDrug
1-4 tablets twice daily
MethamphetamineDrug
intravenous methamphetamine
| Study group | Role | What they receive |
|---|---|---|
| Pomaglumetad methionil Low + Methamphetamine | Experimental | Pomaglumetad 40 mg orally twice daily x 9 days with intravenous methamphetamine challenges Receives: Drug: Pomaglumetad methionil; Drug: Methamphetamine |
| Pomaglumetad methionil Mid + Methamphetamine | Experimental | Pomaglumetad 40 mg orally twice daily x 1 day then pomaglumetad 80 mg orally twice daily x 8 days with intravenous methamphetamine challenges Receives: Drug: Pomaglumetad methionil; Drug: Methamphetamine |
| Pomaglumetad methionil High + Methamphetamine | Experimental | Pomaglumetad 40 mg orally twice daily x 1 day then pomaglumetad 160 mg orally twice daily x 8 days with intravenous methamphetamine challenges Receives: Drug: Pomaglumetad methionil; Drug: Methamphetamine |
| Control + Methamphetamine | Placebo comparator | 1-4 placebo tabs orally twice daily x 9 days (to match pomaglumetad dosing in each cohort) with intravenous methamphetamine challenges Receives: Drug: Placebo; Drug: Methamphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Blood pressure following IV methamphetamine during treatment with pomaglumetad or placebo
Measured: 0 to 240 minutes after IV methamphetamine
Heart rate
Heart rate following IV methamphetamine during treatment with pomaglumetad or placebo
Measured: 0 to 240 minutes after IV methamphetamine
Rate-pressure product
Rate-pressure product (heart rate * systolic blood pressure, a measure of myocardial oxygen consumption and workload) following IV methamphetamine during treatment with pomaglumetad or placebo
Measured: 0 to 240 minutes after IV methamphetamine
Methamphetamine subjective effects
Self-reported methamphetamine subjective effects assessed with Drug Effect Questionnaire (DEQ-5) and Methamphetamine-based Questionnaire for Stimulant Urges (MA-QSU) following IV methamphetamine during treatment with pomaglumetad or placebo
Measured: 0 to 240 minutes after IV methamphetamine
Secondary outcomes (1)
Peak methamphetamine concentration
C-max of methamphetamine during treatment with pomaglumetad or placebo
Measured: 0 to 48 hours after IV methamphetamine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Aug 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Why it stopped: Deemed unable to enroll targeted participants in part due to COVID-19 shut downs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Keith Heinzerling, University of California, Los Angeles
- Investigators
- Keith Heinzerling, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106571
- Sponsor's protocol ID
- R01DA043238
- Other IDs
- R01DA043238
- Acronym
- POMA-MA-Ph1
- Status last verified
- Aug 2020
- First submitted
- 7 Mar 2017
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Safety-interaction Study of Pomaglumetad Methionil for Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT03106571
- Acronym / sponsor ID
- POMA-MA-Ph1 / R01DA043238
- Conditions
- Methamphetamine Use Disorder
- Keywords
- Phase 1 clinical trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Deemed unable to enroll targeted participants in part due to COVID-19 shut downs
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the first study of pomaglumetad in humans using methamphetamine. The goal of the study is to determine if pomaglumetad is safe when administered with methamphetamine. If shown to be safe with methamphetamine in the current study, a phase 2 clinical trial of pomaglumetad would be done to begin to find out if pomaglumetad is effective in treating methamphetamine use disorder.
Detailed description
The study design is a randomized, double-blind, placebo-controlled multiple ascending-dose study of pomaglumetad in 24 non-treatment seeking participants with methamphetamine use disorder. Three cohorts of 8 participants each (total N = 24) will be enrolled and within each cohort participants will be randomly assigned in a 6:2 ratio to undergo methamphetamine infusions and assessments during treatment with pomaglumetad (N = 6 per cohort) or placebo (N = 2 per cohort). Participants in cohort 1 will receive pomaglumetad 40 mg orally twice daily (BID) or placebo, cohort 2 will receive pomaglumetad 80 mg BID or placebo, and cohort 3 will receive pomaglumetad 160 mg BID or placebo.
After completing outpatient baseline and screening/eligibility assessments, eligible participants will be admitted to the UCLA Hospital and will remain hospitalized during all experimental procedures (approximately 11 days and 10 nights).
A urine drug toxicology screen free of illicit substances (with the exception of THC) is required for admission. Upon admission, participants will receive a sample/test infusion of MA 30 mg IV. Participants tolerating the test infusion (no serious adverse advents and not exceeding stopping criteria below) will be randomized to receive POMA (40 mg BID in cohort 1, 80 mg BID in cohort 2, and 160 mg BID in cohort 3) or placebo.
Following three days of MA abstinence and POMA/placebo dosing to achieve study medication steady-state, participants will complete a MA self-administration session.
After two days for MA washout, participants will then have serial plasma samples collected over 12 hours to assess PK for POMA. The next day, participants will receive a 30 mg MA infusion followed by serial plasma sample collection over the following 48 hours for MA PK analysis.
Measures of cardiovascular response, subjective effects, and adverse events will be assessed following all MA infusions during self-administration and PK sessions.
Upon completion of the PK sample collection, participants will be discharged and a 14-day post-discharge (± 7 days) follow-up outpatient visit will be completed for safety purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pomaglumetad methionil Low + Methamphetamine | Experimental | Drug: Pomaglumetad methionil, Drug: MethamphetaminePomaglumetad 40 mg orally twice daily x 9 days with intravenous methamphetamine challenges |
| Pomaglumetad methionil Mid + Methamphetamine | Experimental | Drug: Pomaglumetad methionil, Drug: MethamphetaminePomaglumetad 40 mg orally twice daily x 1 day then pomaglumetad 80 mg orally twice daily x 8 days with intravenous methamphetamine challenges |
| Pomaglumetad methionil High + Methamphetamine | Experimental | Drug: Pomaglumetad methionil, Drug: MethamphetaminePomaglumetad 40 mg orally twice daily x 1 day then pomaglumetad 160 mg orally twice daily x 8 days with intravenous methamphetamine challenges |
| Control + Methamphetamine | Placebo comparator | Drug: Placebo, Drug: Methamphetamine1-4 placebo tabs orally twice daily x 9 days (to match pomaglumetad dosing in each cohort) with intravenous methamphetamine challenges |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- not seeking treatment for MA problems at the time of the study;
- English-speaking;
- age 18-55 years inclusive;
- meet DSM-5 criteria for MA use disorder, moderate-severe as diagnosed via MINI;
- have a self-reported history of using MA either via injection or smoking and provide at least one MA-positive urine prior to admission;
Key exclusion criteria (18 listed)
- non-English speaking;
- currently on probation or parole;
- have current cocaine, opioid, marijuana, or alcohol use disorder, moderate-severe;
- have liver function tests (total bilirubin, ALT, AST, or alkaline phosphatase) ≥ 2 x the upper limit of normal or kidney function tests (creatinine and BUN) ≥ 2 x the upper limit of normal;
- current or past history of seizure disorder;
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 |
|---|---|---|
| Pomaglumetad methionilTablets twice daily | Drug | Pomaglumetad methionil High + Methamphetamine, Pomaglumetad methionil Low + Methamphetamine, Pomaglumetad methionil Mid + Methamphetamine |
| Placebo1-4 tablets twice daily | Drug | Control + Methamphetamine |
| Methamphetamineintravenous methamphetamine | Drug | Control + Methamphetamine, Pomaglumetad methionil High + Methamphetamine, Pomaglumetad methionil Low + Methamphetamine, Pomaglumetad methionil Mid + Methamphetamine |
Primary outcome
Blood pressure
Time frame: 0 to 240 minutes after IV methamphetamine
Blood pressure following IV methamphetamine during treatment with pomaglumetad or placebo
Heart rate
Time frame: 0 to 240 minutes after IV methamphetamine
Heart rate following IV methamphetamine during treatment with pomaglumetad or placebo
Rate-pressure product
Time frame: 0 to 240 minutes after IV methamphetamine
Rate-pressure product (heart rate * systolic blood pressure, a measure of myocardial oxygen consumption and workload) following IV methamphetamine during treatment with pomaglumetad or placebo
Methamphetamine subjective effects
Time frame: 0 to 240 minutes after IV methamphetamine
Self-reported methamphetamine subjective effects assessed with Drug Effect Questionnaire (DEQ-5) and Methamphetamine-based Questionnaire for Stimulant Urges (MA-QSU) following IV methamphetamine during treatment with pomaglumetad or placebo
1 secondary outcome
Peak methamphetamine concentration
Time frame: 0 to 48 hours after IV methamphetamine
Results and safety
The study was stopped early (reason given: Deemed unable to enroll targeted participants in part due to COVID-19 shut downs). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Methamphetamine Use Disorder
Active, not recruitingPhase 2
An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder
Obesity, Methamphetamine Use Disorder
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder
Insomnia
Active, not recruiting
Closed-loop TBS Targeting rPO for the Core Clinical Features of Methamphetamine Use Disorder
Methamphetamine Use Disorder, Substance Use Disorder
RecruitingPhase 2
Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder
Methamphetamine Use Disorder
Recruiting
Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement
Methamphetamine Use, Heart Failure
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.
Keith Heinzerling, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pomaglumetad methionil and Methamphetamine in people with Methamphetamine Use Disorder, run by University of California, Los Angeles at 1 site 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 14 inclusion and 18 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Deemed unable to enroll targeted participants in part due to COVID-19 shut downs). Results are not available in the source record.
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?
Blood pressure (time frame: 0 to 240 minutes after IV methamphetamine). The study lists 4 primary outcomes in all. 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 1 Sep 2020.