Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users (NCT03341078) | Clinical Trial Compass
CompletedPhase 2
Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users
United States176 participantsStarted 2019-05-01
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI)