Alcohol Use DisorderPhase 2NCT07325266
Human Laboratory Study of Apremilast for Alcohol Use Disorder
A Phase 2 study testing Apremilast in people with Alcohol Use Disorder and Alcohol Misuse, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Misuse
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Apr 2026to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 able to complete the questionnaires required by the protocol.
- 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:
Show all 32Show fewer
- 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 substantially interfere with study participation.
- 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
- 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.
Who cannot join
- Contact study site for exclusion criteria
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Kristen Raymond, kristen.raymond@cuanschutz.edu
Joseph Schacht, PhD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22911
Eva Jenkins-Mendoza, BS, 434-243-0562, emj9c@hscmail.mcc.virginia.edu
Tracie Kostelac, 434.243.0563
- Recruiting
University of California
Los Angeles, California, 90095
Jessica Jenkins, MS, 310-206-6756, jenkinsj@ucla.edu
Lara Ray, PhD
About this study
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.
- Conditions
- Alcohol Use Disorder, Alcohol Misuse
- Being tested
- Placebo, Apremilast
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matched Placebo Capsule
ApremilastDrug
Also called Otezla
30 mg capsule
| Study group | Role | What they receive |
|---|---|---|
| Oral Apremilast 60 mg/day | Active comparator | Apremilast, 30mg per capsule, administered twice daily (AM/PM), Placebo, administered once daily (AM) Receives: Drug: Apremilast |
| Oral Apremilast 90 mg/day | Active comparator | Apremilast, 30mg per capsule, 2 capsules (AM) and 1 capsule (PM) Receives: Drug: Apremilast |
| Oral Matched Placebo | Placebo comparator | Placebo, capsule, 2 capsules (AM) and 1 capsule (PM) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Craving
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.
Measured: Week 4
Secondary outcomes (18)
Participants with no heavy drinking days
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.
Measured: Weeks 2-5
Participants abstinent from alcohol
Percentage of participants abstinent from alcohol over the last 4 weeks of the treatment period of treatment.
Measured: Weeks 2-5
Days abstinent from alcohol per week.
Percentage of days abstinent from alcohol per week.
Measured: Weeks 2-5
Participants with at least a WHO 2-level decrease in alcohol consumption
Percentage of participants with at least a WHO 2-level decrease in alcohol consumption
Measured: Weeks 2-5
Heavy drinking days per week
Percentage of heavy drinking days per week
Measured: Weeks 2-5
Participants abstinent from cigarette smoking
Percentage of participants abstinent from cigarette smoking (among smokers at baseline)
Measured: Weeks 4-5
Number of drinks per week
Mean number of drinks per consumed week
Measured: Weeks 2-5
Number of drinks per drinking day
Weekly mean number of drinks consumed per drinking day.
Measured: Weeks 2-5
Alcohol Use Disorder Symptoms
Number of Alcohol User Disorder (AUD) symptoms as measured by MINI AUD
Measured: Week 6
Number of days of cannabis use per week
Mean number of days of cannabis use per week (among cannabis users at baseline)
Measured: Weeks 4-6
Global Health Score
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
Measured: Weeks 4,6
Alcohol Negative Consequences Score
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).
Measured: Weeks 4,6
Sleep Disturbance
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).
Measured: Weeks 4,6
PROMIS pain intensity score
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).
Measured: Weeks 4,6
PROMIS-Anxiety Scale score
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).
Measured: Weeks 4-6
HAM-D17 score
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.
Measured: Weeks 2,4,6
Urge to Drink scale scores
Urge to Drink craving score during the minimum period. Minimum score of = 0 and maximum = 35
Measured: Weeks 2-5
Inflammatory Markers
Clinical chemistry and hematology laboratory tests will be performed at the clinical site's local clinical laboratory.
Measured: Weeks 3, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start3 Apr 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel Falk, PhD, Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325266
- Sponsor's protocol ID
- HLAB-004
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Laboratory Study of Apremilast for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT07325266
- Acronym / sponsor ID
- HLAB-004
- Conditions
- Alcohol Use Disorder, Alcohol Misuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Apremilast 60 mg/day | Active comparator | Drug: ApremilastApremilast, 30mg per capsule, administered twice daily (AM/PM), Placebo, administered once daily (AM) |
| Oral Apremilast 90 mg/day | Active comparator | Drug: ApremilastApremilast, 30mg per capsule, 2 capsules (AM) and 1 capsule (PM) |
| Oral Matched Placebo | Placebo comparator | Drug: PlaceboPlacebo, capsule, 2 capsules (AM) and 1 capsule (PM) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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 able to complete the questionnaires required by the protocol.
Key exclusion criteria (1 listed)
- Contact study site for exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMatched Placebo Capsule | Drug | Oral Matched Placebo |
| ApremilastAlso: Otezla30 mg capsule | Drug | Oral Apremilast 60 mg/day, Oral Apremilast 90 mg/day |
Primary outcome
Alcohol Craving
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.
18 secondary outcomes
Participants with no heavy drinking days
Time frame: Weeks 2-5
Participants abstinent from alcohol
Time frame: Weeks 2-5
Days abstinent from alcohol per week.
Time frame: Weeks 2-5
Participants with at least a WHO 2-level decrease in alcohol consumption
Time frame: Weeks 2-5
Heavy drinking days per week
Time frame: Weeks 2-5
Participants abstinent from cigarette smoking
Time frame: Weeks 4-5
Number of drinks per week
Time frame: Weeks 2-5
Number of drinks per drinking day
Time frame: Weeks 2-5
Alcohol Use Disorder Symptoms
Time frame: Week 6
Number of days of cannabis use per week
Time frame: Weeks 4-6
Global Health Score
Time frame: Weeks 4,6
Alcohol Negative Consequences Score
Time frame: Weeks 4,6
Sleep Disturbance
Time frame: Weeks 4,6
PROMIS pain intensity score
Time frame: Weeks 4,6
PROMIS-Anxiety Scale score
Time frame: Weeks 4-6
HAM-D17 score
Time frame: Weeks 2,4,6
Urge to Drink scale scores
Time frame: Weeks 2-5
Inflammatory Markers
Time frame: Weeks 3, 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Falk, PhD principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apremilast in people with Alcohol Use Disorder and Alcohol Misuse, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Ryan, MBA (3014434225, mryan1@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Craving (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.