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

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT03341078

Collaborator

Portland VA Medical Center (U.S. Fed), Oregon Health and Science University (Other)

Enrollment

Location

Arms

44.1

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

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

Study Type:

Interventional

Anticipated 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.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

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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.

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

Primary Outcome Measures

Effects of ibudilast on neuroinflammation as assessed by positron emission tomography (PET) [6 weeks]
Pre and post differences in brain neuroinflammation will be assessed.
Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI) [6 weeks]
Pre and post differences in brain function will be assessed.

Secondary Outcome Measures

Effects of ibudilast on overall cognitive battery score. [6 weeks]
Pre and post differences in overall cognitive battery score will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	VA Portland Health Care System, Portland, OR	Portland	Oregon	United States	97239

Sponsors and Collaborators

VA Office of Research and Development
Portland VA Medical Center
Oregon Health and Science University

Investigators

Principal Investigator: Milky Kohno, PhD, VA Portland Health Care System, Portland, OR

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT03341078

Other Study ID Numbers:

NURA-001-17F
16768
18176
20053

First Posted:

Nov 14, 2017

Last Update Posted:

Jan 11, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by VA Office of Research and Development

Ibudilast

Methamphetamine

Neuroinflammation

Additional relevant MeSH terms:

Ibudilast

Study Results

No Results Posted as of Jan 11, 2022