Effect of Ibudilast on brain inflammation in methamphetamine users
Brain Function and Connectivity in Methamphetamine Dependence: The Link to Neuroinflammation and the Effects of Ibudilast
This study is testing if the drug Ibudilast can help reduce brain inflammation and improve symptoms in people who are dependent on methamphetamine.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | radiation |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT03341078 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the potential of Ibudilast, a drug with anti-inflammatory properties, to reduce neuroinflammation in individuals with methamphetamine dependence. The study aims to assess whether Ibudilast can alleviate symptoms associated with methamphetamine use, particularly those related to brain inflammation that may impair decision-making. Participants will be randomly assigned to receive either Ibudilast or a placebo while being monitored for changes in inflammation and related symptoms. The study is crucial as there are currently no approved medications for treating methamphetamine addiction.
Who should consider this trial
Good fit: Ideal candidates are individuals who are currently abstinent from all drugs except marijuana and methamphetamine and have a recent diagnosis of Methamphetamine-Use Disorder.
Not a fit: Patients with significant neurological or psychiatric disorders, or those who have been abstinent from methamphetamine for more than four weeks, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for individuals struggling with methamphetamine addiction.
How similar studies have performed: While there is limited research specifically on Ibudilast for methamphetamine addiction, studies on its anti-inflammatory effects suggest potential benefits, making this approach novel yet promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Portland, Oregon
- VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Milky Kohno, PhD — VA Portland Health Care System, Portland, OR
- Study coordinator: Milky Kohno, PhD
- Email: kohno@ohsu.edu
- Phone: (503) 721-7964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.