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Completed

NCT Number: NCT03341078

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibudilast

Drug

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

Placebo oral tablet

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Effects of ibudilast on overall cognitive battery score.

    Time frame: 6 weeks

    Pre and post differences in overall cognitive battery score will be assessed.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Oregon Health and Science University
  • Portland VA Medical Center

Registry information

Official study title

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

Acronym: Ibudilast

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2017
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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