Methamphetamine-dependence
Conditions
Keywords
Ibudilast, Methamphetamine, Neuroinflammation
Brief 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.
Detailed description
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.
Interventions
DRUGIbudilast
Ibudilast capsules will be orally ingested twice daily for 6 weeks.
DRUGPlacebo Oral Tablet
Placebo capsules will be orally ingested twice daily for 6 weeks.
Sponsors
VA Office of Research and Development
Portland VA Medical Center
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Healthy controls will be recruited and have baseline evaluations for neuroinflammation and associated behaviors. Participants with methamphetamine-use disorder will also be recruited and enrolled in a placebo controlled portion of this study. Participants in the placebo controlled portion of this study will be dosed with either the study drug or a placebo twice daily for 6 weeks and will have pre/post evaluations for neuroinflammation and associated behaviors.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI) | 6 weeks | Pre and post differences in brain function will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of ibudilast on overall cognitive battery score. | 6 weeks | Pre and post differences in overall cognitive battery score will be assessed. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMilky Kohno, PhD
VA Portland Health Care System, Portland, OR
Outcome results
None listed