Alcohol Use Disorder study: Apremilast
Official title Human Laboratory Study of Apremilast for Alcohol Use Disorder
ClinicalTrials.gov ID: NCT07325266
What this study is testing
What is Apremilast?
Apremilast is an investigational oral tablet being studied as a potential treatment for alcohol use disorder. Apremilast is designed to inhibit phosphodiesterase‑4 (PDE4), which raises cellular cAMP levels and modulates inflammatory signaling.
Also referred to as Otezla.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether two different amounts of apremilast tablets reduce alcohol cravings in people with moderate to severe alcohol use disorder.
- Who it's for
- You may be able to join if you have moderate to severe alcohol use disorder.
- What's involved
- You will take a tablet each day for two weeks. You will also answer questions about your drinking, cravings, mood, sleep, and other health topics.
- Time commitment
- The study lasts about two weeks with daily dosing and a few check‑in visits.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Be at least 21 years of age.
- 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...
- 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).
- Be seeking treatment for problems with alcohol and express a goal of abstinence or a reduction in drinking.
- Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study...
You likely can't join if
- Contact study site for exclusion criteria
See the full eligibility criteria
- Be at least 21 years of age.
- 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).
- 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).
- Be seeking treatment for problems with alcohol and express a goal of abstinence or a reduction in drinking.
- 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...
- 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.
- Be willing to adhere to the investigational product dosing schedule.
- Complete all assessments required at screening and baseline.
- 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.
- Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 6.
- Not have any plans to move within Study Week 6 to a location which would make continued participation in the study impractical.
- 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.
- Be someone who in the opinion of the investigator would be expected to complete the study protocol.
- 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...
- SSRIs
- Dual uptake inhibitors
- SNRIs
- Tricyclic antidepressants
- MAOIs
- Bupropion
- Not currently taking apremilast and agree not to take non-study supplied apremilast for the duration of the study.
- Have normal renal function defined as creatinine clearance ≥ 60 mL per minute by the Cockcroft-Gault equation.
- Contact study site for exclusion criteria
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Aurora, Colorado, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.