Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users
- Conditions
- Methamphetamine-dependence
- Interventions
- Drug: Placebo Oral Tablet
- Registration Number
- NCT03341078
- Lead Sponsor
- VA Office of Research and Development
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral Tablet Placebo Group will be dosed with a placebo oral tablet twice daily for 6 weeks. Participants will have pre/post evaluations for neuroinflammation and associated behaviors Ibudilast Ibudilast Ibudilast Group will be dosed with ibudilast twice daily for 6 weeks. The first 2 weeks will be 20 mg twice daily followed by 4 weeks of 50 mg twice daily. Participants will have pre/post evaluations for neuroinflammation and associated behaviors
- Primary Outcome Measures
Name Time Method Effects of ibudilast on neuroinflammation as assessed by positron emission tomography (PET) 6 weeks Pre and post differences in brain neuroinflammation will be assessed.
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 Outcome Measures
Name Time Method Effects of ibudilast on overall cognitive battery score. 6 weeks Pre and post differences in overall cognitive battery score will be assessed.
Trial Locations
- Locations (1)
VA Portland Health Care System, Portland, OR
🇺🇸Portland, Oregon, United States