Methamphetamine-dependencePhase 1NCT01217970
Safety Interaction Trial Ibudilast and Methamphetamine
A Phase 1 study testing Ibudilast 20mg and Ibudilast 50mg in people with Methamphetamine-dependence and Substance Abuse, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan and South Korea, ibudilast has been used safely in humans as a treatment for asthma, pulmonary, and cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Methamphetamine-dependence, Substance Abuse
- What is being tested?
- Ibudilast 20mg and Ibudilast 50mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2013
- 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 methamphetamine problems;
- English-speaking;
- Age 18-55;
- Meet SCID criteria for MA dependence;
- Self-reported history of MA use via injection or smoking AND at least one MA positive urine drug screening during eligibility;
- Resting heart rate 50-100BPM; Systolic BP 105-150 mm Hg; Diastolic BP 45-90 mm Hg stabilized within 2 days of admission;
Show all 10Show fewer
- Baseline EKG demonstrating normal sinus rhythm, normal conduction, no clinically significant arrhythmias;
- Use of acceptable barrier method of birth control;
- If female, not pregnant or lactating;
- Have medical history and physical examination demonstrating no additional clinically significant contraindications for study participation, in judgment of investigators.
Who cannot join
- Current dependence on cocaine, opioids, marijuana, or alcohol;
- Liver function tests GE 3x upper limit of normal, or kidney function tests GE 2x the upper limit of normal;
- Current or past history of seizure disorder;
- History of head trauma;
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor-UCLA Medical Center GCRC
Torrance, California, 90502
About this study
Official title: Phase I Safety Interaction Trial of Ibudilast With Methamphetamine
This study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan and South Korea, ibudilast has been used safely in humans as a treatment for asthma, pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in outpatient settings with people who have methamphetamine dependence. This would be the first study to collect this information. This study is important because individuals with methamphetamine dependence often relapse to meth use, even when in treatment; some number of individuals who participate in an outpatient study will relapse to methamphetamine while taking ibudilast. It is crucial to know whether there may be interactions between ibudilast and methamphetamine before planning an outpatient clinical trial.Ibudilast is an exciting medication candidate for treating methamphetamine dependence. When individuals become abstinent from methamphetamine during early recovery, the body starts an inflammatory process in neurons, especially glial cells. Glial cells are important in that they provide support to the nerve cells that are involved in thought, movement, and other human activities. By dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells during early abstinence, which in turn may help individuals feel better and think better during treatment.
The study specific aims are to determine whether ibudilast alters:
Read more
- blood pressure and heart rate responses to methamphetamine;
- the ratings of craving or other drug experiences from methamphetamine;
- the reward/reinforcing effects of methamphetamine; and
- the metabolism of methamphetamine.
Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not looking for treatment will complete this study.
Read the detailed description
This study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan and South Korea, ibudilast has been used safely in humans as a treatment for asthma, pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in outpatient settings with people who have methamphetamine dependence. This would be the first study to collect this information. This study is important because individuals with methamphetamine dependence often relapse to meth use, even when in treatment; some number of individuals who participate in an outpatient study will relapse to methamphetamine while taking ibudilast. It is crucial to know whether there may be interactions between ibudilast and methamphetamine before planning an outpatient clinical trial.
The study will be conducted at the Harbor-UCLA hospital to ensure the medical safety of participants, especially if there are unexpected interactions between ibudilast and methamphetamine on cardiovascular function. Methamphetamine can cause substantial increases in heart rate and blood pressure that last for about 3 hours. This study will measure whether people who are meth-dependent (and not looking for treatment) show increases in their heart rate and blood pressures when given methamphetamine above what is expected by methamphetamine alone and when at the recommended doses of ibudilast.
Ibudilast is an exciting medication candidate for treating methamphetamine dependence. When individuals become abstinent from methamphetamine during early recovery, the body starts an inflammatory process in neurons, especially glial cells. Glial cells are important in that they provide support to the nerve cells that are involved in thought, movement, and other human activities. By dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells during early abstinence, which in turn may help individuals feel better and think better during treatment.
The study specific aims are to determine whether ibudilast alters:
- blood pressure and heart rate responses to methamphetamine;
- the ratings of craving or other drug experiences from methamphetamine;
- the reward/reinforcing effects of methamphetamine; and
- the metabolism of methamphetamine.
Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not looking for treatment will complete this study. Each participant will complete assessments of safety/tolerability, perceived effects of methamphetamine, and an assessment where subjects make choices between different amounts of money and methamphetamine. Each patient will stay in the hospital for a total of 27 nights. The first two days consist of safety infusions to make sure methamphetamine is tolerable. Then, each subject will start study medication and take a 7-day course of three conditions: placebo, ibudilast 20mg BID, and ibudilast 50mg ibudilast. Low dose ibudilast always precedes high dose ibudilast. The order of placebo being first or last is random.
- Conditions
- Methamphetamine-dependence, Substance Abuse
- Being tested
- Ibudilast 20mg, Ibudilast 50mg, Placebo oral tablet
- Keywords
- methamphetamine, dependence, stimulant, amphetamine, los angeles, meth, speed, crank, abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibudilast 20mgDrug
Also called IBUD
Ibudilast 20mg BID
Ibudilast 50mgDrug
Also called IBUD
Ibudilast 50mg BID
Placebo oral tabletDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo, Ibudilast 20 mg, then Ibudilast 50mg | Experimental | Sequence: (1) Placebo, (2) Ibudilast 20 mg BID, then (3) Ibudilast 50 mg BID Receives: Drug: Ibudilast 20mg; Drug: Ibudilast 50mg; Drug: Placebo oral tablet |
| Ibudilast 20 mg, Ibudilast 50mg, then placebo | Experimental | Sequence: (1) Ibudilast 20 mg BID, (2) Ibudilast 50 mg BID, then (3) Placebo Receives: Drug: Ibudilast 20mg; Drug: Ibudilast 50mg; Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Insomnia, Nicotine craving, Gastrointestinal upset, Headache, Musculoskeletal pain, Pain at IV site, Rash, Vivid dreams, Constipation, Dizziness, Dysuria, Ectopic heart beats, Fever/chills/hot flashes, Pruritis, Sore throat, Tinnitus, Backache, Chest congestion, Sedation, or other reported by patient or observed by clinician
Measured: 35 days
Number of Participants with Clinically Significant Changes in Cardiovascular Parameters as a Measure of Safety and Tolerability
Systolic and diastolic blood pressure, heart rate, and an EKG "rhythm strip"
Measured: 35 days
Secondary outcomes (1)
Number of participants with adverse outcomes on (1) VAS, drug-effect scale, subjective effects, etc., and (2) pharmacokinetics of methamphetamine as measures of efficacy
- Barratt Impulsiveness Scale-11; The Wechsler Test of Adult Reading; Wender Utah Rating Scale; subjective intensity of 12 drug effects on VAS.
- blood concentrations of methamphetamine and amphetamine
- cytokine panel from plasma
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine-dependenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 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), MediciNova
- Responsible party
- Sponsor
- Investigators
- Steven Shoptaw, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217970
- Sponsor's protocol ID
- ShoptawPI_ibudilast
- Other IDs
- R01DA029804
- Status last verified
- May 2023
- First submitted
- 6 Oct 2010
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety Interaction Trial of Ibudilast With Methamphetamine
- ClinicalTrials.gov ID
- NCT01217970
- Acronym / sponsor ID
- ShoptawPI_ibudilast
- Conditions
- Methamphetamine-dependence, Substance Abuse
- Keywords
- methamphetamine, dependence, stimulant, amphetamine, los angeles, meth, speed, crank
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), MediciNova
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Oct 2010 (estimated)
- 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 study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan and South Korea, ibudilast has been used safely in humans as a treatment for asthma, pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in outpatient settings with people who have methamphetamine dependence. This would be the first study to collect this information. This study is important because individuals with methamphetamine dependence often relapse to meth use, even when in treatment; some number of individuals who participate in an outpatient study will relapse to methamphetamine while taking ibudilast. It is crucial to know whether there may be interactions between ibudilast and methamphetamine before planning an outpatient clinical trial.Ibudilast is an exciting medication candidate for treating methamphetamine dependence. When individuals become abstinent from methamphetamine during early recovery, the body starts an inflammatory process in neurons, especially glial cells. Glial cells are important in that they provide support to the nerve cells that are involved in thought, movement, and other human activities. By dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells during early abstinence, which in turn may help individuals feel better and think better during treatment.
The study specific aims are to determine whether ibudilast alters:
- blood pressure and heart rate responses to methamphetamine;
- the ratings of craving or other drug experiences from methamphetamine;
- the reward/reinforcing effects of methamphetamine; and
- the metabolism of methamphetamine.
Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not looking for treatment will complete this study.
Detailed description
This study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan and South Korea, ibudilast has been used safely in humans as a treatment for asthma, pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in outpatient settings with people who have methamphetamine dependence. This would be the first study to collect this information. This study is important because individuals with methamphetamine dependence often relapse to meth use, even when in treatment; some number of individuals who participate in an outpatient study will relapse to methamphetamine while taking ibudilast. It is crucial to know whether there may be interactions between ibudilast and methamphetamine before planning an outpatient clinical trial.
The study will be conducted at the Harbor-UCLA hospital to ensure the medical safety of participants, especially if there are unexpected interactions between ibudilast and methamphetamine on cardiovascular function. Methamphetamine can cause substantial increases in heart rate and blood pressure that last for about 3 hours. This study will measure whether people who are meth-dependent (and not looking for treatment) show increases in their heart rate and blood pressures when given methamphetamine above what is expected by methamphetamine alone and when at the recommended doses of ibudilast.
Ibudilast is an exciting medication candidate for treating methamphetamine dependence. When individuals become abstinent from methamphetamine during early recovery, the body starts an inflammatory process in neurons, especially glial cells. Glial cells are important in that they provide support to the nerve cells that are involved in thought, movement, and other human activities. By dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells during early abstinence, which in turn may help individuals feel better and think better during treatment.
The study specific aims are to determine whether ibudilast alters:
- blood pressure and heart rate responses to methamphetamine;
- the ratings of craving or other drug experiences from methamphetamine;
- the reward/reinforcing effects of methamphetamine; and
- the metabolism of methamphetamine.
Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not looking for treatment will complete this study. Each participant will complete assessments of safety/tolerability, perceived effects of methamphetamine, and an assessment where subjects make choices between different amounts of money and methamphetamine. Each patient will stay in the hospital for a total of 27 nights. The first two days consist of safety infusions to make sure methamphetamine is tolerable. Then, each subject will start study medication and take a 7-day course of three conditions: placebo, ibudilast 20mg BID, and ibudilast 50mg ibudilast. Low dose ibudilast always precedes high dose ibudilast. The order of placebo being first or last is random.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo, Ibudilast 20 mg, then Ibudilast 50mg | Experimental | Drug: Ibudilast 20mg, Drug: Ibudilast 50mg, Drug: Placebo oral tabletSequence: (1) Placebo, (2) Ibudilast 20 mg BID, then (3) Ibudilast 50 mg BID |
| Ibudilast 20 mg, Ibudilast 50mg, then placebo | Experimental | Drug: Ibudilast 20mg, Drug: Ibudilast 50mg, Drug: Placebo oral tabletSequence: (1) Ibudilast 20 mg BID, (2) Ibudilast 50 mg BID, then (3) Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- NOT seeking treatment for methamphetamine problems;
- English-speaking;
- Age 18-55;
- Meet SCID criteria for MA dependence;
- Self-reported history of MA use via injection or smoking AND at least one MA positive urine drug screening during eligibility;
Key exclusion criteria (4 listed)
- Current dependence on cocaine, opioids, marijuana, or alcohol;
- Liver function tests GE 3x upper limit of normal, or kidney function tests GE 2x the upper limit of normal;
- Current or past history of seizure disorder;
- History of head trauma;
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 |
|---|---|---|
| Ibudilast 20mgAlso: IBUDIbudilast 20mg BID | Drug | Ibudilast 20 mg, Ibudilast 50mg, then placebo, placebo, Ibudilast 20 mg, then Ibudilast 50mg |
| Ibudilast 50mgAlso: IBUDIbudilast 50mg BID | Drug | Ibudilast 20 mg, Ibudilast 50mg, then placebo, placebo, Ibudilast 20 mg, then Ibudilast 50mg |
| Placebo oral tabletAlso: Placebo | Drug | Ibudilast 20 mg, Ibudilast 50mg, then placebo, placebo, Ibudilast 20 mg, then Ibudilast 50mg |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 35 days
Insomnia, Nicotine craving, Gastrointestinal upset, Headache, Musculoskeletal pain, Pain at IV site, Rash, Vivid dreams, Constipation, Dizziness, Dysuria, Ectopic heart beats, Fever/chills/hot flashes, Pruritis, Sore throat, Tinnitus, Backache, Chest congestion, Sedation, or other reported by patient or observed by clinician
Number of Participants with Clinically Significant Changes in Cardiovascular Parameters as a Measure of Safety and Tolerability
Time frame: 35 days
Systolic and diastolic blood pressure, heart rate, and an EKG "rhythm strip"
1 secondary outcome
Number of participants with adverse outcomes on (1) VAS, drug-effect scale, subjective effects, etc., and (2) pharmacokinetics of methamphetamine as measures of efficacy
Time frame: 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
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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.
Steven Shoptaw, PhD 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 Ibudilast 20mg and Ibudilast 50mg in people with Methamphetamine-dependence and Substance Abuse, 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 10 inclusion and 4 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 15 May 2023. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Adverse Events as a Measure of Safety and Tolerability (time frame: 35 days). The study lists 2 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 15 May 2023.