Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users
NCT ID: NCT03341078
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2019-05-01
2025-10-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Placebo Oral Tablet
Placebo capsules will be orally ingested twice daily for 6 weeks.
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
Ibudilast
Ibudilast capsules will be orally ingested twice daily for 6 weeks.
Controls
Healthy controls will only undergo baseline evaluations and will not be enrolled in the drug portion of the study.
No interventions assigned to this group
Interventions
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Ibudilast
Ibudilast capsules will be orally ingested twice daily for 6 weeks.
Placebo Oral Tablet
Placebo capsules will be orally ingested twice daily for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Meet diagnosis for recent Methamphetamine-Use Disorder (DSM-V) or does not meet any substance-use disorders
Exclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Portland VA Medical Center
FED
Oregon Health and Science University
OTHER
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Milky Kohno, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Portland Health Care System, Portland, OR
Locations
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VA Portland Health Care System, Portland, OR
Portland, Oregon, United States
Countries
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Other Identifiers
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16768
Identifier Type: OTHER
Identifier Source: secondary_id
18176
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20053
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NURA-001-17F
Identifier Type: -
Identifier Source: org_study_id
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