Placebo
Matched Placebo Capsule
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Primary: The primary objective of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among subjects with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing. Secondary: Secondary objectives include evaluation of two different maintenance doses of apremilast compared with matched placebo on other measures of self-reported alcohol consumption, alcohol craving, alcohol-related negative consequences, AUD symptoms, pain, sleep disturbances, depression, anxiety, quality of life, cigarette smoking, other nicotine use, cannabis use, retention in the study, and safety.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-05-01
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This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Matched Placebo Capsule
30 mg capsule
OtezlaEligibility
primary outcomes
Time frame: Week 4
The primary outcome measure of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among participants with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing.
secondary outcomes
Time frame: Weeks 2-5
Percentage of participants with no heavy drinking days over the last 4 weeks of the treatment period. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
Time frame: Weeks 2-5
Percentage of participants abstinent from alcohol over the last 4 weeks of the treatment period of treatment.
Time frame: Weeks 2-5
Percentage of days abstinent from alcohol per week.
Time frame: Weeks 2-5
Percentage of participants with at least a WHO 2-level decrease in alcohol consumption
Time frame: Weeks 2-5
Percentage of heavy drinking days per week
Time frame: Weeks 4-5
Percentage of participants abstinent from cigarette smoking (among smokers at baseline)
Time frame: Weeks 2-5
Mean number of drinks per consumed week
Time frame: Weeks 2-5
Weekly mean number of drinks consumed per drinking day.
Time frame: Week 6
Number of Alcohol User Disorder (AUD) symptoms as measured by MINI AUD
Time frame: Weeks 4-6
Mean number of days of cannabis use per week (among cannabis users at baseline)
Time frame: Weeks 4,6
The PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health Scale is QOL assessment to evaluate the clinical benefit of apremilast treatment. It is a 10-question self-report measure that rates items on a 5-item ordinal scale (5 = Excellent, 1 = Poor) over the past 7 days. It assesses five core health domains: physical function, pain, fatigue, emotional distress, and social health. Scores will be converted to T-scores (normalized for comparison across populations). Lower scores correspond to more severe problems. Global health score measured by the PROMIS-Global Health scale
Time frame: Weeks 4,6
For negative consequences for alcohol use, the short form of the PROMIS Patient-Reported Outcomes Measurement Information System) Alcohol Negative Consequences questionnaire will be used to assess outcomes of alcohol use over the past 7 days. This 7-item questionnaire assesses physical and social consequences of drinking. Scores will be converted to T-scores (normalized for comparison across populations).
Time frame: Weeks 4,6
The PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbances Scale - short form is an 8-item scale asking questions about sleep disturbances in the past 7-days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. Scores will be converted to T-scores (normalized for comparison across populations).
Time frame: Weeks 4,6
The PROMIS (Patient-Reported Outcomes Measurement Information System) Adult Short Form version 1.0 Pain Intensity will be used to assess pain intensity using a 7-day recall period (2 items) and pain intensity right now (1 item). Each item has a 5-point scale with anchors at "had no pain" and "very severe". The responses to each item will be summed to calculate a total pain intensity score. Scores will be converted to T-scores (normalized for comparison across populations).
Time frame: Weeks 4-6
The PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety Scale - short form is a 8-item scale asking questions about anxiety in the past 7 days with anchors at 1 (never) and 5 (always). Interpretation of scoring is as follows: Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety. Scores will be converted to T-scores (normalized for comparison across populations).
Time frame: Weeks 2,4,6
A 17-item clinician administered Hamilton Depression scale (HAM-D17) will be used to monitor the development of depressive symptom throughout the study. A structed interview guide must be followed by the administrator performing this assessment. HAM-D17 scores of below 7 (no depression), 7 to 17 (mild depression), 18 to 24 (moderate depression) and 25 and above (severe depression) (Carrozzino-2020). This questionnaire will be completed by the interviewer and will be both the source and eCRF.
Time frame: Weeks 2-5
Urge to Drink craving score during the minimum period. Minimum score of = 0 and maximum = 35
Time frame: Weeks 3, 6
Clinical chemistry and hematology laboratory tests will be performed at the clinical site's local clinical laboratory.
Publications
No exact PMID-linked public article is currently readable locally.