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Phosphodiesterase inhibitor

Ibudilast for Alcoholism

Phase 2
Waitlist Available
Led By Lara A. Ray, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-week treatment period
Awards & highlights

Study Summary

This trialtests a new drug to treat Alcohol Use Disorder over 16 weeks with 5 visits. Participants will take the drug twice a day to see if it helps.

Eligible Conditions
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-week treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-week treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent heavy drinking days
Secondary outcome measures
Drinks per day
Drinks per drinking day
Percent days abstinent
+2 more
Other outcome measures
Depressive Symptomatology
Neuroinflammation

Side effects data

From 2017 Phase 2 trial • 125 Patients • NCT01860807
50%
Headache
17%
Nausea
16%
Insomnia
13%
Diarrhea
2%
Suicide Attempt
2%
Convulsion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibudilast
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IbudilastExperimental Treatment1 Intervention
10mg delayed-release capsules, target dose 50mg BID (5 x 10mg capsules twice daily) for 12 weeks
Group II: Placebo Oral CapsulePlacebo Group1 Intervention
matched to experimental drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibudilast
Not yet FDA approved

Find a Location

Who is running the clinical trial?

MediciNovaIndustry Sponsor
19 Previous Clinical Trials
1,418 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,278,100 Total Patients Enrolled
16 Trials studying Alcoholism
3,684 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,365,295 Total Patients Enrolled
423 Trials studying Alcoholism
985,606 Patients Enrolled for Alcoholism

Frequently Asked Questions

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

Has the FDA sanctioned Ibudilast for therapeutic use?

"With limited evidence of efficacy, the safety score for Ibudilast was assessed at 2 based on the Phase 2 trial data."

Answered by AI

Is this research program currently enrolling participants?

"Correct. According to clinicaltrials.gov, this investigation is still in need of participants and was initially posted on October 1st 2018. The latest update occurred on the 10th of October 2022, which calls for 132 people across a single location."

Answered by AI

Am I eligible to take part in this clinical experiment?

"Those wishing to be part of this research study must experience mild-to-severe alcohol use disorder, and should fall between 18 years old and 65. This trial is looking for roughly 132 participants in total."

Answered by AI

Does this trial accept participants older than thirty years?

"This medical study has a predetermined age range of 18-65, while there are 33 trials for minors and 252 studies that specifically recruit patients over 65."

Answered by AI

Is this investigation the inaugural endeavor of its type?

"Ibudilast was first investigated in 2018, and shortly after the 132 person clinical trial concluded it received its Phase 2 approval. As of today, there are 4 different trials occurring across 24 cities spread over 3 countries."

Answered by AI

How many participants are engaged in the study?

"Correct. According to the information on clinicaltrials.gov, this trial is actively enrolling patients - it was initially published in October 2018 and most recently updated in October 2022. A total of 132 participants are needed across 1 medical centre."

Answered by AI

Could you detail the previous research projects involving Ibudilast?

"Presently, 4 studies involving ibudilast are in progress. 2 of these trials have progressed to Phase 3 and there are 30 different locations conducting research for this therapy; primarily based in Portland, Oregon."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ibudilast for the Treatment of Alcohol Use Disorder
Lara Ray, PhD 2018. "Ibudilast for the Treatment of Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03594435.
~16 spots leftby Apr 2025
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