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

VA Office of Research and Development

Status and phase: Completed; Phase 2

Conditions: Methamphetamine-dependence

Treatments: Drug: Placebo Oral Tablet; Drug: Ibudilast

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03341078

18176 (Other Grant/Funding Number)

NURA-001-17F

16768 (Other Identifier)

20053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Oral Tablet

Ibudilast

Active Comparator group

Description:

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

Treatment:

Drug: Ibudilast

Controls

No Intervention group

Description:

Healthy controls will only undergo baseline evaluations and will not be enrolled in the drug portion of the study.