Apremilast vs. placebo for adults with alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, double-blind, placebo-controlled trial compares apremilast 60 mg per day to placebo in adults with DSM-5 alcohol use disorder who are not seeking treatment. After a 6-day titration to reach steady-state levels, participants undergo three laboratory sessions with personalized imagery followed by a 2-hour alcohol self-administration period. They then take the study medication for 28 days with naturalistic drinking monitored, and have a 1-month post-treatment follow-up after discontinuation. Safety and adverse events are monitored at each visit. Participants are randomized 1:1 to apremilast or placebo and will be assessed for eligibility through intake screening and a physical exam.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 21-65.
2. Able to read and write English.
3. Meets DSM-5 criteria for current (past 6 months) AUD.
4. Drinking criteria: males - drinks \> 14 drinks per week and exceeds 4 drinks per day at least twice per week; females - drinks \> 7 drinks per week and exceeds 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period prior to baseline.
5. Laboratory sessions will be scheduled such that subjects will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam).
6. Able to take oral medications and willing to adhere to medication regimen.
7. Provision of signed and dated informed consent form
8. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

1. Subjects with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions, including HIV.
2. Current DSM-5 substance use disorder (other than AUD or tobacco use disorder).
3. A positive test result at intake appointment on urine drug screens conducted for illicit drugs.
4. Past 30-day use of psychoactive drugs may be included at the discretion of the study MD as long as the concurrent treatment does not compromise the study integrity by virtue of its type, duration, or intensity.
5. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or her partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD).
6. Suicidal, homicidal, or evidence of current (past 6 months) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders.
7. Only one member per household can participate in the study.
8. Specific exclusions for administration of apremilast not already specified include: known hypersensitivity to apremilast; cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin).
9. Drugs that may influence study outcomes (e.g., disulfiram, naltrexone, acamprosate, anticonvulsants).
10. Subjects likely to exhibit clinically significant alcohol withdrawal during the study. We will exclude subjects who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b) have a score of \> 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments.
11. Subjects who have taken any investigational drug within 4 weeks immediately preceding admission to the study period.
12. Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current application.
13. Individuals who are currently in treatment for drinking or who have attempted to quit drinking within the past 3 months in order to exclude participants seeking treatment.
14. Individuals with a history of serious withdrawal, and individuals who have repeatedly undergone alcohol detoxification.

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Sherry McKee, PhD — Yale University
• Study coordinator: Meaghan Lavery
• Email: meaghan.lavery@yale.edu
• Phone: 203-737-2783

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.