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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Nov 8, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Ibudilast on reducing inflammation in the brains of people who are addicted to methamphetamine. Methamphetamine addiction is a serious issue, and currently, there are no approved medications to help individuals stop using it. The goal of this study is to explore whether Ibudilast can assist in the recovery process for those struggling with methamphetamine use.

To participate in this trial, individuals must be between the ages of 18 and 65, have recently been diagnosed with methamphetamine use disorder, and must not be using any other drugs except for marijuana. They should also be clean from methamphetamine for at least four weeks. Participants will undergo screenings to ensure their safety and will have the opportunity to receive treatment with Ibudilast. This study is currently recruiting participants, and anyone interested should consult with their healthcare provider to see if they qualify.

Gender

ALL

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