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

NCT03341078 | Completed Phase 2 DMC FDA Drug

• 4 other identifiers: NURA-001-17F167681817620053
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine-dependence

Keywords

Ibudilast; Methamphetamine; Neuroinflammation

Outcome Measures

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.

  6 weeks

Secondary Outcomes (1)

• Effects of ibudilast on overall cognitive battery score.

  6 weeks

Study Arms (3)

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

Ibudilast DRUG

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

Ibudilast

Placebo Oral Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Portland VA Medical Center: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

MeSH Terms

Conditions

Neuroinflammatory Diseases

Interventions

ibudilast

Condition Hierarchy (Ancestors)

Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Milky Kohno, PhD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 14, 2017
• Study Start: May 1, 2019
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)