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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University; VA Office of Research and Development
• Collaborators: Oregon Health and Science University; Portland VA Medical Center
• Treatments: Ibudilast; Methamphetamine

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