ClinicalTrials.gg
CompletedNCT03341078IbudilastUpdated Feb 2, 2026

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

A Phase 2 interventional study of Ibudilast and Placebo Oral Tablet in Methamphetamine-dependence, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by VA Office of Research and Development · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2025, 1 year ago, and no results have been posted to the registry.

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Phase
Phase 2
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 59 studies in Neuroinflammatory Diseases with a site in United States — 21 open to participants now, 26 under way, none of them phase 3. Neuroinflammatory Diseases · United States.

Enrollment
Largest of 38
176 · median 30
Started
2019
with 1 other
Phase 2
15 of 59
6 open now
Registered
16th of 59
by date
Lead sponsor
2 of 59
VA Office of Research and Development

Among the 59 studies in Neuroinflammatory Diseases with a site in United States, this one has the largest enrollment of the 38 interventional ones that give a count, is one of 2 that started in 2019, is one of 15 in phase 2, and was the 16th registered.

Neuroinflammatory Diseases

180 studies on the registry are indexed under Neuroinflammatory Diseases; 80 are open to participants now.

Browse Neuroinflammatory Diseases studies →

Open to participants now

21 of the 59 studies in Neuroinflammatory Diseases with a site in United States are open now. Recruiting first, the newest first:

16 more — sign in →

All 21 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 53 Neuroinflammatory Diseases studies recruiting now, 16 (30%) set no upper age limit and 24 (45%) stop at 75 or younger; 11 take children under 18; 17 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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. Ibudilast (the study drug) is a drug that could help people addicted to methamphetamine.

Read the detailed description

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. Ibudilast (the study drug) is a drug that could help people addicted to methamphetamine.

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.

03

Conditions studied

  • Methamphetamine-dependence

Keywords

  • Ibudilast
  • Methamphetamine
  • Neuroinflammation
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 () or does not meet any substance-use disorders

Exclusion criteria

Exclusion Criteria:

  • Known sensitivity to ibudilast
  • Left handed
  • MRI
  • 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
  • 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 levels greater than 3 times the upper limit
  • Participation in any drug study in the last 3 months
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
176 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    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

    Drug: Placebo Oral Tablet

  • Active comparator
    Ibudilast

    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

    Drug: Ibudilast

  • No intervention
    Controls

    Healthy controls will only undergo baseline evaluations and will not be enrolled in the drug portion of the study.

Interventions

  • Ibudilast capsules will be orally ingested twice daily for 6 weeks.

  • DrugPlacebo Oral Tablet

    Placebo capsules will be orally ingested twice daily for 6 weeks.

06

What researchers measure

Primary outcomes

  1. Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI)

    Pre and post differences in brain function will be assessed.

    Time frame: 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.

    Time frame: 6 weeks

07

Study locations

1 site
  • VA Portland Health Care System, Portland, OR
    Portland, Oregon 97207-2964, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2019 to primary completion in Oct 2025, 77 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2017
First posted
Nov 14, 2017
StartActual
May 1, 2019
Primary completionActual
Oct 15, 2025
CompletionActual
Oct 15, 2025
Last update
Feb 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03341078
Collaborators
Portland VA Medical Center, Oregon Health and Science University
Responsible party
Sponsor
First posted
Nov 14, 2017
Start date
May 1, 2019
Primary completion
Oct 15, 2025
Completion
Oct 15, 2025
Last update
Feb 2, 2026

Study contacts

Milky Kohno, PhD
principal investigator · VA Portland Health Care System, Portland, OR

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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