Health TrialsbyHealthPanel

Human Laboratory Study of Apremilast for Alcohol Use Disorder

ConditionsAlcohol Use DisorderAlcohol Misuse
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    Matched Placebo Capsule

  • Apremilast

    Drug

    30 mg capsule

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Oral Apremilast 60 mg/dayActive comparator 1 intervention
Group B: Oral Apremilast 90 mg/dayActive comparator 1 intervention
Group C: Oral Matched PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 4

Secondary outcomes

1

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.

Time frame
Weeks 2-5
2

Participants abstinent from alcohol

Percentage of participants abstinent from alcohol over the last 4 weeks of the treatment period of treatment.

Time frame
Weeks 2-5
3

Days abstinent from alcohol per week.

Percentage of days abstinent from alcohol per week.

Time frame
Weeks 2-5
4

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

Time frame
Weeks 2-5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Lead sponsor

Source ClinicalTrials.gov
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