Human Laboratory Study of Apremilast for Alcohol Use Disorder
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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. 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
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria (not exhaustive list): 1. Be at least 21 years of age. 2. 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). 3. 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). 4. Be seeking treatment for problems with alcohol and express a goal of abstinence or a reduction in drinking. 5. Be able to verbalize an understanding of the consent form, able to provide written i…
Interventions
- DrugPlacebo
Matched Placebo Capsule
- DrugApremilast
30 mg capsule
Locations (3)
- University of CaliforniaLos Angeles, California
- University of ColoradoAurora, Colorado
- University of VirginiaCharlottesville, Virginia