Methamphetamine-dependencePhase 2IbudilastNCT03341078

Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users

A Phase 2 study testing Ibudilast in people with Methamphetamine-dependence, run by VA Office of Research and Development at 1 site in United States.

Completed

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

Official record

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Trial summary

Addiction to methamphetamine is a serious health problem in the United States. Right now, there are no medications that a doctor can give someone to help them stop using methamphetamine. More research is needed to develop drugs for methamphetamine addiction. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Methamphetamine-dependence
What is being tested?: Ibudilast
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 176 participants
Where: 1 siteUnited States
Study dates: 1 May 2019to 15 Oct 2025
Phase: Phase 2
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
Healthy volunteers accepted
Adult

Who may be able to join

abstinent from all drugs except marijuana and methamphetamine and have a negative urine drug screen on test days
Meet diagnosis for recent Methamphetamine-Use Disorder (DSM-V) or does not meet any substance-use disorders

Who cannot join

Known sensitivity to ibudilast
Left handed
MRI contraindications
Clinically significant neurological, endocrine, renal, hepatic, or systemic diseases that would compromise safe participation or confound outcomes
Any psychiatric diagnoses or primary psychotic or mood disorders (past depression diagnoses allowed)
Any drug use disorder diagnosis besides methamphetamine or tobacco

Show all 14Show fewer

Any recreational or prescriptive use of psychotropic medications
Claustrophobia
Women who are pregnant or breast-feeding
Neurodegenerative diseases that present with neuroinflammation
More than 4 weeks abstinent from methamphetamine
rs6971 genotype that confers low translocator protein (TSPO) binding affinity to prevent unnecessary radiation exposure
Liver disease requiring medication or medical treatment and/or aspartate or alanine aminotransferase levels greater than 3 times the upper limit
Participation in any drug study in the last 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964

Other trials in United States

About this study

Official title: Brain Function and Connectivity in Methamphetamine Dependence: The Link to Neuroinflammation and the Effects of Ibudilast

Read the detailed description

The investigators are interested to know if the study drug can help some symptoms that methamphetamine can cause, specifically inflammation in the brain. Inflammation has been shown to affect decision-making. The study drug has anti-inflammatory properties, however it is not yet known whether the drug will reduce inflammation in the brain.

Conditions: Methamphetamine-dependence
Being tested: Ibudilast, Placebo Oral Tablet
Keywords: Ibudilast, Methamphetamine, Neuroinflammation
Medical subject headings: Neuroinflammatory Diseases

What participants receive

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

IbudilastDrug
Ibudilast capsules will be orally ingested twice daily for 6 weeks.
Placebo Oral TabletDrug
Placebo capsules will be orally ingested twice daily for 6 weeks.

Study groups in NCT03341078
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Group will be dosed with a placebo oral tablet twice daily for 6 weeks. Participants will have pre/post evaluations for neuroinflammation and associated behaviors Receives: Drug: Placebo Oral Tablet
Ibudilast	Active comparator	Ibudilast Group will be dosed with ibudilast twice daily for 6 weeks. The first 2 weeks will be 20 mg twice daily followed by 4 weeks of 50 mg twice daily. Participants will have pre/post evaluations for neuroinflammation and associated behaviors Receives: Drug: Ibudilast
Controls	No intervention	Healthy controls will only undergo baseline evaluations and will not be enrolled in the drug portion of the study.

What is being measured

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

Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI)
Pre and post differences in brain function will be assessed.
Measured: 6 weeks

Secondary outcomes (1)

Effects of ibudilast on overall cognitive battery score.
Pre and post differences in overall cognitive battery score will be assessed.
Measured: 6 weeks

Timeline

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

1 May 201915 Oct 2025

First posted14 Nov 2017
Study start1 May 2019
Primary completion15 Oct 2025
Study completion15 Oct 2025

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 VA Office of Research and DevelopmentThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Healthy controls will be recruited and have baseline evaluations for neuroinflammation and associated behaviors. Participants with methamphetamine-use disorder will also be recruited and enrolled in a placebo controlled portion of this study. Participants in the placebo controlled portion of this study will be dosed with either the study drug or a placebo twice daily for 6 weeks and will have pre/post evaluations for neuroinflammation and associated behaviors.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03341078
Sponsor's protocol ID: NURA-001-17F
Other IDs: 16768, 18176, 20053
Acronym: Ibudilast
Status last verified: Jan 2026
First submitted: 26 Oct 2017
Last updated: 2 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
The Human Stress Response in a Simulated ED Setting
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rTMS for Craving in Methamphetamine Use Disorder
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Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder
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All Methamphetamine-dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Function and Connectivity in Methamphetamine Dependence: The Link to Neuroinflammation and the Effects of Ibudilast
ClinicalTrials.gov ID: NCT03341078
Acronym / sponsor ID: Ibudilast / NURA-001-17F
Conditions: Methamphetamine-dependence
Keywords: Ibudilast, Methamphetamine, Neuroinflammation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: Portland VA Medical Center, Oregon Health and Science University
Study start: 1 May 2019 (actual)
Primary completion: 15 Oct 2025 (actual)
Study completion: 15 Oct 2025 (actual)
First posted: 14 Nov 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: Healthy controls will be recruited and have baseline evaluations for neuroinflammation and associated behaviors. Participants with methamphetamine-use disorder will also be recruited and enrolled in a placebo controlled portion of this study. Participants in the placebo controlled portion of this study will be dosed with either the study drug or a placebo twice daily for 6 weeks and will have pre/post evaluations for neuroinflammation and associated behaviors.

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo Oral TabletPlacebo Group will be dosed with a placebo oral tablet twice daily for 6 weeks. Participants will have pre/post evaluations for neuroinflammation and associated behaviors
Ibudilast	Active comparator	Drug: IbudilastIbudilast Group will be dosed with ibudilast twice daily for 6 weeks. The first 2 weeks will be 20 mg twice daily followed by 4 weeks of 50 mg twice daily. Participants will have pre/post evaluations for neuroinflammation and associated behaviors
Controls	No intervention	–Healthy controls will only undergo baseline evaluations and will not be enrolled in the drug portion of the study.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

abstinent from all drugs except marijuana and methamphetamine and have a negative urine drug screen on test days
Meet diagnosis for recent Methamphetamine-Use Disorder (DSM-V) or does not meet any substance-use disorders

Key exclusion criteria (14 listed)

Known sensitivity to ibudilast
Left handed
MRI contraindications
Clinically significant neurological, endocrine, renal, hepatic, or systemic diseases that would compromise safe participation or confound outcomes
Any psychiatric diagnoses or primary psychotic or mood disorders (past depression diagnoses allowed)

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
IbudilastIbudilast capsules will be orally ingested twice daily for 6 weeks.	Drug	Ibudilast
Placebo Oral TabletPlacebo capsules will be orally ingested twice daily for 6 weeks.	Drug	Placebo

Primary outcome

Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI)
Time frame: 6 weeks
Pre and post differences in brain function will be assessed.

1 secondary outcome

Effects of ibudilast on overall cognitive battery score.
Time frame: 6 weeks

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 2 Feb 2026.
Individual participant dataSharing planned: No

Related trials for Methamphetamine-dependence

Active, not recruiting
The Human Stress Response in a Simulated ED Setting
Stress Physiology, Stress Reaction
Recruiting
rTMS for Craving in Methamphetamine Use Disorder
Methamphetamine Abuse, Substance Use Disorders
Active, not recruitingPhase 3
Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder
Methamphetamine-dependence, Methamphetamine Abuse
RecruitingPhase 2
Glutide for Ending Methamphetamine
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RecruitingPhase 2
Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
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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.

Milky Kohno, PhD principal investigator

VA Portland Health Care System, Portland, OR

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibudilast in people with Methamphetamine-dependence, run by VA Office of Research and Development 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 2 inclusion and 14 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 2 Feb 2026. 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 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?

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?

Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI) (time frame: 6 weeks). 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 NCT03341078.

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 2 Feb 2026.