Clinical trial NCT03341078: Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users
Official title: Brain Function and Connectivity in Methamphetamine Dependence: The Link to Neuroinflammation and the Effects of Ibudilast
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Methamphetamine-dependence
Keywords: Ibudilast
Methamphetamine
Neuroinflammation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Portland VA Medical Center
name: Oregon Health and Science University
First posted: 2017-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effects of ibudilast on neuroinflammation as assessed by positron emission tomography (PET)
timeFrame: 6 weeks
measure: Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI)
timeFrame: 6 weeks
Secondary outcomes:
measure: Effects of ibudilast on overall cognitive battery score.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Milky Kohno, PhD
role: PRINCIPAL_INVESTIGATOR
References: