Could an arthritis drug curb alcohol cravings?
NCT ID NCT07325266
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether apremilast (Otezla), a drug currently used for psoriasis and arthritis, can reduce alcohol cravings in people with moderate to severe alcohol use disorder. Researchers will compare two different doses of the drug against a placebo in 100 adults who want to cut back or quit drinking. The main goal is to see if the drug lowers cravings after two weeks of daily use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- apremilast (Otezla)
- What this could lead to
- If it works, this could point toward a new medication to help people with alcohol use disorder reduce their drinking and cravings.
- What could go wrong
- This is a phase 2 trial with only 100 people, so results are still early. The drug may not work better than a placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
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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21 years and older
- 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 (not exhaustive list): 1. Be at least 21 years of age. 2. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity). 3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent). 4. Be seeking treatment for problems with alcohol and express a goal of abstinence or a reduction in drinking. 5. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol. 6. Agree (if the participant is female and of childbearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal: * oral contraceptives, * contraceptive sponge, * patch, * double barrier (diaphragm/spermicidal or condom/spermicidal), * intrauterine contraceptive system, * etonogestrel implant, * medroxyprogesterone acetate contraceptive injection, * complete abstinence from sexual intercourse, and/or * hormonal vaginal contraceptive ring. 7. Be willing to adhere to the investigational product dosing schedule. 8. Complete all assessments required at screening and baseline. 9. Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing by Study Week 6. 10. Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 6. 11. Not have any plans to move within Study Week 6 to a location which would make continued participation in the study impractical. 12. Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the participant in case of a missed clinic appointment. 13. Be someone who in the opinion of the investigator would be expected to complete the study protocol. 14. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation. 15. If taking a medication for depression, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following: * SSRIs * Dual uptake inhibitors * SNRIs * Tricyclic antidepressants * MAOIs * Bupropion 16. Not currently taking apremilast and agree not to take non-study supplied apremilast for the duration of the study. 17. Have normal renal function defined as creatinine clearance ≥ 60 mL per minute by the Cockcroft-Gault equation. Exclusion Criteria: Contact study site for exclusion criteria
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California
RECRUITINGLos Angeles, California, 90095, United States
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University of Colorado
RECRUITINGAurora, Colorado, 80045, United States
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University of Virginia
RECRUITINGCharlottesville, Virginia, 22911, United States
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