Could an asthma drug curb alcohol cravings? new trial investigates.
NCT ID NCT05414240
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether ibudilast, an anti-inflammatory drug used in Japan, can help people with alcohol use disorder drink less. Fifty adults will take either ibudilast or a placebo for 6 weeks, plus counseling. The main goal is to see if it reduces the number of heavy drinking days.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Physically healthy, based on medical history and physical examination and approval of the study physician 2. Meets current DSM-5 criteria for AUD 3. Average weekly ethanol consumption of \>24 standard drinks for men and \>18 standard drinks for women, with a weekly average of \> 2 HDDs during the month before screening 4. Stated goal to reduce drinking to safe levels or to stop drinking 5. Able to read English at an 6th grade or higher level and no gross cognitive impairment 6. Willingness to nominate an individual who will know the subject's whereabouts to facilitate follow up during the study 7. Women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or less than two years postmenopausal) must be non-lactating and practicing a reliable method of birth control and have a negative urine pregnancy test prior to the initiation of treatment. Examples of medically acceptable methods for this protocol include: the birth control pill, intrauterine device, injection of Depo-Provera, Norplant, contraceptive patch, contraceptive ring, double-barrier methods (such as condoms and diaphragm/spermicide), male partner sterilization, abstinence (and agreement to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence), and tubal ligation. 8. Willingness to provide signed, informed consent and commit to completing the procedures in the study Exclusion Criteria: 1. A current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of \>110% or a transaminase elevation \>300% of normal 2. Current, serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, panic disorder, borderline or antisocial personality disorder, organic mood or mental disorders, eating disorder, or imminent suicide or violence risk) 3. Current DSM-5 diagnosis of dependence on a drug other than alcohol, marijuana or nicotine 4. Current regular treatment with a psychotropic medication (e.g., benzodiazepines, anticonvulsants), which affect neurotransmitter systems, or a medication to treat alcohol dependence. Stable antidepressant treatment for at least 1 month is acceptable. 5. Urine drug screen positive for recent use of opioids, cocaine, or amphetamines (may be repeated once and if the result is negative on repeat it is not exclusionary) 6. Judged by the principal investigator or his designee to be an unsuitable candidate for receipt of an investigational drug
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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