Alcohol Use DisorderPhase 2NCT03175549
Medication Development in Alcoholism: Apremilast Versus Placebo
A Phase 2 study testing Apremilast in people with Alcohol Use Disorder, run by The Scripps Research Institute at 1 site in United States.
Trial summary
The primary hypotheses under test are that alcohol dependent subjects treated with apremilast will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- 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
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 1 Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female volunteers, 18-65 years of age
- Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity (AUD-MS)
- In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (≥ 5 males, ≥ 4 females) per week.
- Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues
- Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session
- Negative BAC and a CIWA score of < 9 at time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures.
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- In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, EKG, routine urine and blood chemistry.
- Females with childbearing potential must have a negative pregnancy test on the screening, randomization, and lab session visits and agree to use effective birth control for the duration required by a given study.
- Able to provide informed consent and understand questionnaires and study procedure
- Willing to comply with the provisions of the protocol and take daily oral medication.
Who cannot join
- Active suicidal ideation, as systematically assessed with the Columbia Suicide Severity Rating Scale.
- Meets DSM-5 criteria for a major psychiatric disorder, including mood or anxiety disorders or substance use disorders other than alcohol or nicotine
- Has a urine drug screen (UDS) positive for substances of abuse other than alcohol.
- Significant medical disorders that will increase potential risk or interfere with study participation as determined by the study physician
- Known hypersensitivity to apremilast
- Treatment within the month prior to screening with (1) an investigational drug, (2) medications which may negatively interact with study medications, or (3) drugs that may influence study outcomes (e.g., disulfiram [Antabuse], naltrexone [ReVia], acamprosate [Campral], anticonvulsants, or antidepressants).
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- Ongoing treatment with medications that may increase risk, including prescribed, over-the-counter, and herbal preparations, as determined by the study physician.
- Sexually active female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective methods of birth control for the duration required by a specific protocol.
- No fixed domicile and/or no availability by home or mobile telephone
- History of hypersensitivity to the study drug or the ingredients.
- Failure to take double-blind medication as prescribed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
La Jolla, California, 92037
About this study
Official title: Medication Development for Protracted Abstinence in Alcoholism: Apremilast Versus Placebo
The primary hypotheses under test are that alcohol dependent subjects treated with apremilast will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.
- Conditions
- Alcohol Use Disorder
- Being tested
- Apremilast, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called Otezla
Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days.
PlaceboDrug
Also called Sugar Pill
Identical placebo pills taken orally for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Apremilast (Otezla) | Active comparator | Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days. Receives: Drug: Apremilast |
| Placebo | Placebo comparator | Identical placebo pills taken orally for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving to Drink
Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.
Measured: 1 hour on the last day of dosing (Day 14)
Secondary outcomes (1)
Drinking
Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.
Treatment effects on drinking were accessed during the 11 days of ad libidum and did not include the final three days of mandatory abstinence prior to cue reactivity testing on day 14 of dosing.
Measured: 11 days (Treatment effects on drinking were accessed during the 11 days of ad libidum and did not include the final three days of mandatory abstinence prior to cue reactivity testing on day 14 of dosing.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Nov 2017
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment, Double Blind, Randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Scripps Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Barbara J. Mason, Ph.D., Principal investigator, The Scripps Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175549
- Sponsor's protocol ID
- U01AA025476
- Status last verified
- Aug 2022
- First submitted
- 1 Jun 2017
- Last updated
- 16 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Development for Protracted Abstinence in Alcoholism: Apremilast Versus Placebo
- ClinicalTrials.gov ID
- NCT03175549
- Acronym / sponsor ID
- U01AA025476
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The Scripps Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Posted 16 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypotheses under test are that alcohol dependent subjects treated with apremilast will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment, Double Blind, Randomized
| Arm | Type | Receives |
|---|---|---|
| Apremilast (Otezla) | Active comparator | Drug: ApremilastFixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboIdentical placebo pills taken orally for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female volunteers, 18-65 years of age
- Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity (AUD-MS)
- In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (≥ 5 males, ≥ 4 females) per week.
- Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues
- Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session
Key exclusion criteria (11 listed)
- Active suicidal ideation, as systematically assessed with the Columbia Suicide Severity Rating Scale.
- Meets DSM-5 criteria for a major psychiatric disorder, including mood or anxiety disorders or substance use disorders other than alcohol or nicotine
- Has a urine drug screen (UDS) positive for substances of abuse other than alcohol.
- Significant medical disorders that will increase potential risk or interfere with study participation as determined by the study physician
- Known hypersensitivity to apremilast
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 |
|---|---|---|
| ApremilastAlso: OtezlaFixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days. | Drug | Apremilast (Otezla) |
| PlaceboAlso: Sugar PillIdentical placebo pills taken orally for 14 days | Drug | Placebo |
Primary outcome
Craving to Drink
Time frame: 1 hour on the last day of dosing (Day 14)
Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.
1 secondary outcome
Drinking
Time frame: 11 days (Treatment effects on drinking were accessed during the 11 days of ad libidum and did not include the final three days of mandatory abstinence prior to cue reactivity testing on day 14 of dosing.)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Barbara J. Mason, Ph.D. principal investigator
The Scripps Research Institute
1 site 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, run by The Scripps Research Institute at 1 site 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 10 inclusion and 11 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: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 16 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving to Drink (time frame: 1 hour on the last day of dosing (Day 14)). 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 16 Sep 2022.