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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    65
  • sponsor
    VA Office of Research and Development
Updated on 26 March 2022
Accepts healthy volunteers

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.

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.

Details
Condition Methamphetamine-dependence
Treatment ibudilast, Placebo Oral Tablet
Clinical Study IdentifierNCT03341078
SponsorVA Office of Research and Development
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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