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

Methamphetamine-dependence Clinical Trial

— Ibudilast  

Official title:

Brain Function and Connectivity in Methamphetamine Dependence: The Link to Neuroinflammation and the Effects of Ibudilast

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03341078
• Other study ID #: NURA-001-17F
• Secondary ID: 167681817620053
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Milky Kohno, PhD
• Phone: (503) 721-7964
• Email: kohno[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Methamphetamine-dependence

Intervention

Drug:
• Ibudilast
Ibudilast capsules will be orally ingested twice daily for 6 weeks.
• Placebo Oral Tablet
Placebo capsules will be orally ingested twice daily for 6 weeks.

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Oregon Health and Science University, Portland VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of ibudilast on neuroinflammation as assessed by positron emission tomography (PET)	Pre and post differences in brain neuroinflammation will be assessed.	6 weeks
Primary	Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI)	Pre and post differences in brain function will be assessed.	6 weeks
Secondary	Effects of ibudilast on overall cognitive battery score.	Pre and post differences in overall cognitive battery score will be assessed.	6 weeks