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

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ClinicalTrials.gov Identifier: NCT03341078
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
Portland VA Medical Center
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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 is needed to develop drugs for methamphetamine addiction. Ibudilast (the study drug) is a drug that could help people addicted to methamphetamine.

Condition or disease Intervention/treatment Phase
Methamphetamine-dependence Drug: Ibudilast Drug: Placebo Oral Tablet Phase 2

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Healthy controls will be recruited and have baseline evaluations for neuroinflammation and associated behaviors. Participants with methamphetamine-use disorder will also be recruited and enrolled in a placebo controlled portion of this study. Participants in the placebo controlled portion of this study will be dosed with either the study drug or a placebo twice daily for 6 weeks and will have pre/post evaluations for neuroinflammation and associated behaviors.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Brain Function and Connectivity in Methamphetamine Dependence: The Link to Neuroinflammation and the Effects of Ibudilast
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
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
 Drug: Placebo Oral Tablet
Placebo capsules will be orally ingested twice daily for 6 weeks.
Active Comparator: Ibudilast
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
 Drug: Ibudilast
Ibudilast capsules will be orally ingested twice daily for 6 weeks.
No Intervention: Controls
Healthy controls will only undergo baseline evaluations and will not be enrolled in the drug portion of the study.


Outcome Measures
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Primary Outcome Measures :
  1. Effects of ibudilast on neuroinflammation as assessed by positron emission tomography (PET) [ Time Frame: 6 weeks ]
    Pre and post differences in brain neuroinflammation will be assessed.

  2. Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI) [ Time Frame: 6 weeks ]
    Pre and post differences in brain function will be assessed.


Secondary Outcome Measures :
  1. Effects of ibudilast on overall cognitive battery score. [ Time Frame: 6 weeks ]
    Pre and post differences in overall cognitive battery score will be assessed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341078


Contacts
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Contact: Milky Kohno, PhD (503) 721-7964 kohno@ohsu.edu
Contact: Laura Dennis, BS (503) 220-8262 ext 56707 laura.dennis@va.gov

Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: Milky Kohno, PhD    503-721-7964    kohno@ohsu.edu   
Principal Investigator: Milky Kohno, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Portland VA Medical Center
Oregon Health and Science University
Investigators
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Principal Investigator: Milky Kohno, PhD VA Portland Health Care System, Portland, OR
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03341078    
Other Study ID Numbers: NURA-001-17F
16768 ( Other Identifier: Portland VA Medical Center )
18176 ( Other Grant/Funding Number: OHSU )
20053 ( Other Grant/Funding Number: OHSU Circle of Giving )
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Ibudilast
Methamphetamine
Neuroinflammation
Additional relevant MeSH terms:
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Ibudilast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents