SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03341078

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

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.

NCT03341078 Methamphetamine-dependence

2 Interventions

Name: Ibudilast

Description: Ibudilast capsules will be orally ingested twice daily for 6 weeks.

Type: Drug

Ibudilast

Name: Placebo Oral Tablet

Description: Placebo capsules will be orally ingested twice daily for 6 weeks.

Type: Drug

Placebo


Primary Outcomes

Description: Pre and post differences in brain neuroinflammation will be assessed.

Measure: Effects of ibudilast on neuroinflammation as assessed by magnetic resonance spectroscopy (MRS)

Time: 6 weeks

Description: Pre and post differences in brain neuroinflammation will be assessed.

Measure: Effects of ibudilast on neuroinflammation as assessed by positron emission tomography (PET)

Time: 6 weeks

Description: Pre and post differences in brain function will be assessed.

Measure: Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI)

Time: 6 weeks

Secondary Outcomes

Description: Pre and post differences in overall cognitive battery score will be assessed.

Measure: Effects of ibudilast on overall cognitive battery score.

Time: 6 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs6971

Pre and post differences in brain function will be assessed.. Effects of ibudilast on overall cognitive battery score.. Pre and post differences in overall cognitive battery score will be assessed.. Inclusion Criteria: - abstinent from all drugs 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 Inclusion Criteria: - abstinent from all drugs 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 Methamphetamine-dependence null



HPO Nodes