Pilot Study of the Effect of Ibudilast on Neuroinflammati... | NCT03341078

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

NCT03341078

Sponsor

VA Office of Research and Development

Status

Completed

Last Update Posted

Feb 2, 2026Actual

Enrollment

176Actual

Phase

Phase 2

Conditions

Methamphetamine-dependence

Interventions

Ibudilast
Placebo Oral Tablet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
16768	Other Identifier	Portland VA Medical Center
18176	Other Grant/Funding Number	OHSU
20053	Other Grant/Funding Number	OHSU Circle of Giving

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Oct 15, 2025Actual

Completion Date

Oct 15, 2025Actual

First Submitted Date

Oct 26, 2017

First Submission Date that Met QC Criteria

Nov 8, 2017

First Posted Date

Nov 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2026

Last Update Posted Date

Feb 2, 2026Actual

Name	Class
Portland VA Medical Center	FED
Oregon Health and Science University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

176Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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	Drug: Ibudilast
Controls	No Intervention	Healthy controls will only undergo baseline evaluations and will not be enrolled in the drug portion of the study.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ibudilast	Drug	Ibudilast capsules will be orally ingested twice daily for 6 weeks.	Ibudilast

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Effects of ibudilast on overall cognitive battery score.	Pre and post differences in overall cognitive battery score will be assessed.	6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 (DSM-V) or does not meet any substance-use disorders

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Milky Kohno, PhD	VA Portland Health Care System, Portland, OR	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Portland Health Care System, Portland, OR		Portland	Oregon	97207-2964	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Jan 20, 2026	Jan 28, 2026	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000090862	Neuroinflammatory Diseases

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
C038366	ibudilast

Intervention 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.