Status:
RECRUITING
Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Portland VA Medical Center
Oregon Health and Science University
Conditions:
Methamphetamine-dependence
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03341078
Start Date
May 1 2019
End Date
June 30 2026
Last Update
July 30 2025
Active Locations (1)
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1
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97207-2964