Human Laboratory Study of Apremilast for Alcohol Use Disorder
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
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
Treatments tested in this trial
- Placebo
- Apremilast
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov