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New treatment option for Alcohol Use Disorder
Official title Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
ClinicalTrials.gov ID: NCT07029529
What this study is testing
What is Apremilast 60mg?
Apremilast 60mg is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for alcohol use disorder.
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
- For this protocol, the investigators plan to collect data to evaluate apremilast (60mg/day) vs placebo in adults with Alcohol Use Disorders (AUD).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Age 21-65.
- Able to read and write English.
- Meets DSM-5 criteria for current (past 6 months) AUD.
- 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...
- Laboratory sessions will be scheduled such that people will not have major responsibilities on the following day which might limit drinking during...
You likely can't join if
- people with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium or...
- Current DSM-5 substance use disorder (other than AUD or tobacco use disorder).
- A positive test result at intake appointment on urine drug screens conducted for illicit drugs.
- 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...
- 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...
- Suicidal, homicidal, or evidence of current (past 6 months) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety...
See the full eligibility criteria
- Age 21-65.
- Able to read and write English.
- Meets DSM-5 criteria for current (past 6 months) AUD.
- 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...
- Laboratory sessions will be scheduled such that people will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam).
- Able to take oral medications and willing to adhere to medication regimen.
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- people with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions, including HIV.
- Current DSM-5 substance use disorder (other than AUD or tobacco use disorder).
- A positive test result at intake appointment on urine drug screens conducted for illicit drugs.
- 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.
- 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...
- Suicidal, homicidal, or evidence of current (past 6 months) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders.
- Only one member per household can participate in the study.
- Specific exclusions for administration of apremilast not already specified include: known hypersensitivity to apremilast; cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin).
- Drugs that may influence study outcomes (e.g., disulfiram, naltrexone, acamprosate, anticonvulsants).
- people likely to exhibit clinically significant alcohol withdrawal during the study. We will exclude people who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b)...
- people who have taken any investigational drug within 4 weeks immediately preceding admission to the study period.
- Participation within the past 8 weeks in other studies that involve additive blood sampling and/or treatment measures that would be considered excessive in combination with the current application.
- 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.
- Individuals with a history of serious withdrawal, and individuals who have repeatedly undergone alcohol detoxification.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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 to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.