A Study of LY2940094 in Participants With Alcohol Dependency
- Registration Number
- NCT01798303
- Lead Sponsor
- BlackThorn Therapeutics, Inc.
- Brief Summary
The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce alcohol drinking in these participants. The study will last for 8 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
- Present with alcohol dependence (AD) defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR 303.9)
- Must have 3 to 6 heavy drinking days per week as assessed by the Timeline Follow Back (TLFB) scale at screening and baseline (heavy drinking is defined as greater than 4 drinks per day for females and greater than 5 drinks per day for males)
- Have a body mass index (BMI) between 18 and 35 kilograms per square meter (kg/m^2)
Exclusion Criteria
- Have had prior seizures or other condition that would place the participant at increased risk of seizures, and participants taking anticonvulsants for seizure control
- Have any other clinically significant medical condition or circumstance prior to randomization that, in the opinion of the investigator, could affect participant safety
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM-IV) Axis I criteria for a lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar I disorder, or other psychoses
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY2940094 LY2940094 40 mg LY2940094 oral tablet, QD for 8 weeks Placebo Placebo Identically matched placebo oral tablet, QD for 8 weeks
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 8 in the Average Number of Drinks per Day (NDD) Measured Over 28 Days Baseline, Week 8
- Secondary Outcome Measures
Name Time Method Change from Baseline to Week 8 in Gammaglutamyl Transferase (GGT) Baseline, Week 8 Percentage of Heavy Drinking Days per Month Baseline and Week 8 Percentage of Days Abstinent per Month Baseline and Week 8 Percentage of Participants with No (0) Heavy Drinking Days per Month Baseline and Week 8
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇺🇸Charleston, South Carolina, United States