RECRUITING

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

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Conditions

Methamphetamine-dependenceIbudilastMethamphetamineNeuroinflammation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-05-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03341078

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * abstinent from all drugs except marijuana and methamphetamine and have a negative urine drug screen on test days
  2. * Meet diagnosis for recent Methamphetamine-Use Disorder (DSM-V) or does not meet any substance-use disorders
  1. * Known sensitivity to ibudilast
  2. * Left handed
  3. * MRI contraindications
  4. * Clinically significant neurological, endocrine, renal, hepatic, or systemic diseases that would compromise safe participation or confound outcomes
  5. * Any psychiatric diagnoses or primary psychotic or mood disorders (past depression diagnoses allowed)
  6. * Any drug use disorder diagnosis besides methamphetamine or tobacco
  7. * Any recreational or prescriptive use of psychotropic medications
  8. * Claustrophobia
  9. * Women who are pregnant or breast-feeding
  10. * Neurodegenerative diseases that present with neuroinflammation
  11. * More than 4 weeks abstinent from methamphetamine
  12. * rs6971 genotype that confers low translocator protein (TSPO) binding affinity to prevent unnecessary radiation exposure
  13. * Liver disease requiring medication or medical treatment and/or aspartate or alanine aminotransferase levels greater than 3 times the upper limit
  14. * Participation in any drug study in the last 3 months

Contacts and Locations

Study Contact

Milky Kohno, PhD
CONTACT
(503) 721-7964
kohno@ohsu.edu
Laura Dennis, BS
CONTACT
(503) 220-8262
laura.dennis@va.gov

Principal Investigator

Milky Kohno, PhD
PRINCIPAL_INVESTIGATOR
VA Portland Health Care System, Portland, OR

Study Locations (Sites)

VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Milky Kohno, PhD, PRINCIPAL_INVESTIGATOR, VA Portland Health Care System, Portland, OR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-05-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Ibudilast
  • Methamphetamine
  • Neuroinflammation

Additional Relevant MeSH Terms

  • Methamphetamine-dependence