Alcohol Use DisorderPhase 2NCT03594435
Ibudilast for the Treatment of Alcohol Use Disorder
A Phase 2 study testing Ibudilast in people with Alcohol Use Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study is a double-blind, placebo-controlled randomized clinical trial of Ibudilast (IBUD) (50mg twice a day) for the treatment of Alcohol Use Disorder (AUD). Eligible participants will undergo a 12-week medication treatment period and 5 in-person visits over 16 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Ibudilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 19 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between the ages of 18 and 65
- Meet current (i.e., past 12 months) Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for alcohol use disorder moderate or severe
- Be treatment-seeking for alcohol use disorder (AUD)
- Report drinking at least 28 drinks per week if male (21 drinks per week if female) in the 28 days prior to consent
Who cannot join
- Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
- Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
- Have a positive urine screen for narcotics, amphetamines, or sedative hypnotics;
- Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
- Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:
- Oral contraceptives
Show all 20Show fewer
- Contraceptive sponge
- Patch
- Double barrier
- Intrauterine contraceptive device
- Etonogestrel implant
- Medroxyprogesterone acetate contraceptive injection
- Complete abstinence from sexual intercourse
- Hormonal vaginal contraceptive ring
- Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
- Have aspartate aminotransferase (AST), alanine transaminase (ALT), or gamma-glutamyl transferase (GGT) ≥ 3 times upper normal limit
- Have attempted suicide in the past 3 years and/or have had serious suicidal intention or plan in the past year
- Currently be on prescription medication that contraindicates use of ibudilast (IBUD), including alpha or beta agonists, theophylline, or other sympathomimetic
- Currently be on any medications for AUD or any psychotropic medications (e.g., psychostimulants and benzodiazepines) with the exception of stable antidepressants (stable dose for ≥4 weeks)
- Have any other circumstances that, in the opinion of the investigators, compromises participant safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Addictions Laboratory
Los Angeles, California, 90095
About this study
Official title: A Randomized Controlled Clinical Trial of the Neuroimmune Modulator Ibudilast for the Treatment of Alcohol Use Disorder
This study is a double-blind, placebo-controlled randomized clinical trial of Ibudilast (IBUD) (50mg twice a day) for the treatment of Alcohol Use Disorder (AUD). Eligible participants will undergo a 12-week medication treatment period and 5 in-person visits over 16 weeks.
Read the detailed description
The study design consists of a 12-week, double-blind, placebo-controlled randomized clinical trial of IBUD (50mg twice a day) for the treatment of AUD. The investigators will randomize 132 treatment-seekers with current AUD over the course of 4 years. Participants will complete telephone screening, followed by in-person eligibility assessment, a physical exam for medical eligibility, randomization to study medication or matched placebo, and in-person follow-up visits at 4, 8, and 12 weeks of treatment. Timeline Followback (TLFB) assessment of drinking outcomes will also occur by telephone on weeks 2, 6, and 10. A final safety check visit will occur on week 16, consisting of repeated clinical labs and electrocardiography (ECG).
- Conditions
- Alcohol Use Disorder
- Being tested
- Ibudilast, Placebo oral capsule
- Keywords
- ibudilast, treatment, medication development
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbudilastDrug
Also called Pinatos, MN-166
targets neurotrophin signaling and neuroimmune function
Placebo oral capsuleDrug
Also called Sugar Pill
matched to active drug, ibudilast
| Study group | Role | What they receive |
|---|---|---|
| Ibudilast | Experimental | 10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks Receives: Drug: Ibudilast |
| Placebo Oral Capsule | Placebo comparator | matched to experimental drug Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Heavy Drinking Days
Heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measures are proportions of heavy drinking days.
Measured: 12 week-treatment period
Secondary outcomes (3)
Drinks Per Day
Secondary alcohol consumption endpoint. Outcome measure reported is the proportion of drinks per day. Drinks per day across the trial. Randomization is the first day of study intervention after study eligibility was determined.
Measured: 12-week treatment period
Drinks Per Drinking Day
Secondary alcohol consumption endpoint. Drinks per drinking day is defined as how many drinks an individual consumed on a day they reported drinking alcohol.
Measured: 12-week treatment period
Percent Days Abstinent
Secondary alcohol consumption endpoint. Outcome measure reported is the proportion of percent days abstinent.
Measured: 12-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Oct 2018
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-Arm, Randomized, Double-Blind, Placebo-Controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), MediciNova
- Responsible party
- Principal investigator, Lara Ray, PhD, University of California, Los Angeles
- Investigators
- Lara A. Ray, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594435
- Sponsor's protocol ID
- 18-000963
- Other IDs
- R01AA026190
- Status last verified
- Nov 2024
- First submitted
- 11 Jul 2018
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McManus KR, Enders C, Kirsch DE, Belnap M, Grodin EN, Ray LA. Peripheral inflammation mediates the relationship between early life stress and alcohol use. Psychopharmacology (Berl). 2026 Jan 28:10.1007/s00213-026-07009-8. doi: 10.1007/s00213-026-07009-8. Online ahead of print.
PubMed 41603979Ray LA, Meredith LR, Grodin EN, Belnap MA, Nieto SJ, Baskerville WA, Donato S, Shoptaw SJ, Gillis AJ, Irwin MR, Miotto K, Enders CK. A Neuroimmune Modulator for Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e257523. doi: 10.1001/jamanetworkopen.2025.7523.
PubMed 40305022Burnette EM, Baskerville WA, Grodin EN, Ray LA. Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial. Trials. 2020 Sep 11;21(1):779. doi: 10.1186/s13063-020-04670-y.
PubMed 32912290
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of the Neuroimmune Modulator Ibudilast for the Treatment of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03594435
- Acronym / sponsor ID
- 18-000963
- Conditions
- Alcohol Use Disorder
- Keywords
- ibudilast, treatment, medication development
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), MediciNova
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a double-blind, placebo-controlled randomized clinical trial of Ibudilast (IBUD) (50mg twice a day) for the treatment of Alcohol Use Disorder (AUD). Eligible participants will undergo a 12-week medication treatment period and 5 in-person visits over 16 weeks.
Detailed description
The study design consists of a 12-week, double-blind, placebo-controlled randomized clinical trial of IBUD (50mg twice a day) for the treatment of AUD. The investigators will randomize 132 treatment-seekers with current AUD over the course of 4 years. Participants will complete telephone screening, followed by in-person eligibility assessment, a physical exam for medical eligibility, randomization to study medication or matched placebo, and in-person follow-up visits at 4, 8, and 12 weeks of treatment. Timeline Followback (TLFB) assessment of drinking outcomes will also occur by telephone on weeks 2, 6, and 10. A final safety check visit will occur on week 16, consisting of repeated clinical labs and electrocardiography (ECG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Two-Arm, Randomized, Double-Blind, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Ibudilast | Experimental | Drug: Ibudilast10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks |
| Placebo Oral Capsule | Placebo comparator | Drug: Placebo oral capsulematched to experimental drug |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be between the ages of 18 and 65
- Meet current (i.e., past 12 months) Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for alcohol use disorder moderate or severe
- Be treatment-seeking for alcohol use disorder (AUD)
- Report drinking at least 28 drinks per week if male (21 drinks per week if female) in the 28 days prior to consent
Key exclusion criteria (20 listed)
- Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
- Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
- Have a positive urine screen for narcotics, amphetamines, or sedative hypnotics;
- Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
- Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbudilastAlso: Pinatos, MN-166targets neurotrophin signaling and neuroimmune function | Drug | Ibudilast |
| Placebo oral capsuleAlso: Sugar Pillmatched to active drug, ibudilast | Drug | Placebo Oral Capsule |
Primary outcome
Percent Heavy Drinking Days
Time frame: 12 week-treatment period
Heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measures are proportions of heavy drinking days.
3 secondary outcomes
Drinks Per Day
Time frame: 12-week treatment period
Drinks Per Drinking Day
Time frame: 12-week treatment period
Percent Days Abstinent
Time frame: 12-week treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41603979McManus KR, Enders C, Kirsch DE, Belnap M, Grodin EN, Ray LA. Peripheral inflammation mediates the relationship between early life stress and alcohol use. Psychopharmacology (Berl). 2026 Jan 28:10.1007/s00213-026-07009-8. doi: 10.1007/s00213-026-07009-8. Online ahead of print.
- Derived from this study: PubMed 40305022Ray LA, Meredith LR, Grodin EN, Belnap MA, Nieto SJ, Baskerville WA, Donato S, Shoptaw SJ, Gillis AJ, Irwin MR, Miotto K, Enders CK. A Neuroimmune Modulator for Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e257523. doi: 10.1001/jamanetworkopen.2025.7523.
- Derived from this study: PubMed 32912290Burnette EM, Baskerville WA, Grodin EN, Ray LA. Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial. Trials. 2020 Sep 11;21(1):779. doi: 10.1186/s13063-020-04670-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara A. Ray, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibudilast in people with Alcohol Use Disorder, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Heavy Drinking Days (time frame: 12 week-treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03594435, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.