← Back to Search

Phosphodiesterase Inhibitor

Ibudilast for Methamphetamine Addiction (Ibudilast Trial)

Phase 2
Recruiting
Led By Milky Kohno, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Abstinent from all drugs except marijuana and methamphetamine and have a negative urine drug screen on test days
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Ibudilast Trial Summary

This trial is testing whether ibudilast can help people addicted to methamphetamine quit the drug.

Who is the study for?
This trial is for individuals who are currently using methamphetamine but not other drugs, except marijuana. They must have a recent diagnosis of Methamphetamine-Use Disorder and cannot be pregnant or breastfeeding, nor can they have neurodegenerative diseases, severe liver disease, certain psychiatric disorders, or be on psychotropic medications.Check my eligibility
What is being tested?
The study is testing Ibudilast—a potential medication to help with methamphetamine addiction—against a placebo (a pill without active drug). Participants will receive either the study drug or placebo to assess if Ibudilast reduces neuroinflammation associated with meth use.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed, common side effects of Ibudilast may include headache, nausea, dizziness and stomach pain. Since it targets inflammation in the brain, there might also be risks related to mood changes or cognitive functions.

Ibudilast Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I only use marijuana or methamphetamine and will test negative for other drugs.

Ibudilast Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI)
Effects of ibudilast on neuroinflammation as assessed by positron emission tomography (PET)
Secondary outcome measures
Effects of ibudilast on overall cognitive battery score.

Ibudilast Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: ControlsActive Control1 Intervention
Healthy controls will only undergo baseline evaluations and will not be enrolled in the drug portion of the study.
Group II: IbudilastActive Control1 Intervention
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
Group III: PlaceboPlacebo Group1 Intervention
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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,064 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
7,385,692 Total Patients Enrolled
Portland VA Medical CenterFED
41 Previous Clinical Trials
7,222 Total Patients Enrolled

Media Library

Ibudilast (Phosphodiesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03341078 — Phase 2
Methamphetamine Addiction Research Study Groups: Placebo, Controls, Ibudilast
Methamphetamine Addiction Clinical Trial 2023: Ibudilast Highlights & Side Effects. Trial Name: NCT03341078 — Phase 2
Ibudilast (Phosphodiesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03341078 — Phase 2
Methamphetamine Addiction Patient Testimony for trial: Trial Name: NCT03341078 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation currently accepting participants?

"Indeed, candidates are being sought after for this clinical trial. It was first published on May 1st 2019 and the latest modifications were made to it as recently as January 6th 2022."

Answered by AI

Is participation in this research restricted to those aged 35 and under?

"This research program is open to participants who fall in between 18 and 55 years old."

Answered by AI

Has Ibudilast been sanctioned by the FDA?

"There is moderate evidence of Ibudilast's safety, thus it has a score of 2. As this trial is in the Phase 2 stage, there are no clinical data that fully supports its efficacy yet."

Answered by AI

Who would be eligible for participation in this clinical experiment?

"This research is seeking 65 individuals, aged 18-55 that are currently dependent on methamphetamine and fulfill the following conditions: abstention from all substances other than marijuana and methamphetamines; negative urine drug test results for scheduled tests; diagnosis of recent Methamphetamine-Use Disorder (DSM-V) or no substance use disorders."

Answered by AI

Is this the inaugural research project of its genre?

"Presently, 4 clinical studies focusing on Ibudilast are running in 24 locations spread across 3 countries. This research was initiated by MediciNova back in 2018 and involved 132 participants who completed their Phase 2 drug trials. Since then, a further 182 examinations have been concluded."

Answered by AI

Can you enumerate other research undertakings surrounding Ibudilast?

"Presently, four clinical trials are in progress to assess the efficacy of Ibudilast. Two of these investigations have reached Phase 3 and more than 30 medical sites across the United States are conducting research on this medication; the majority being located within Portland, Oregon."

Answered by AI

How many participants are there in this research project?

"Affirmative. The information featured on clinicaltrials.gov asserts that recruitment for this trial is ongoing and has been since May 1st 2019, with the latest update occurring on January 6th 2022. 65 individuals must be enrolled from a single medical institution."

Answered by AI

Who else is applying?

What state do they live in?
California
Arizona
Colorado
How old are they?
18 - 65
What site did they apply to?
VA Portland Health Care System, Portland, OR
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0

Why did patients apply to this trial?

Please help me get off this drug. Usmc Purple Heart Disabled Veteran desperately searching for help.
PatientReceived 2+ prior treatments
A desire to stop using with limited access to resources and treatment. Been addicted since I was 18. I'm high functioning. Would give anything to not battle this addiction.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. VA Portland Health Care System, Portland, OR: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users
2019. "Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03341078.
~4 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top