- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01798303
A Study of LY2940094 in Participants With Alcohol Dependency
February 1, 2017 updated by: BlackThorn Therapeutics, Inc.
Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial in Patients With Alcohol Dependence
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06519
- 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.
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Florida
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North Miami, Florida, United States, 33161
- 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.
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Indiana
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Indianapolis, Indiana, United States, 46260
- 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.
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Oregon
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Portland, Oregon, United States, 97210
- 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.
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South Carolina
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Charleston, South Carolina, United States, 29425
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LY2940094
40 mg LY2940094 oral tablet, QD for 8 weeks
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Administered orally
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Placebo Comparator: Placebo
Identically matched placebo oral tablet, QD for 8 weeks
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Administered orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline to Week 8 in the Average Number of Drinks per Day (NDD) Measured Over 28 Days
Time Frame: Baseline, Week 8
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Baseline, Week 8
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline to Week 8 in Gammaglutamyl Transferase (GGT)
Time Frame: Baseline, Week 8
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Baseline, Week 8
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Percentage of Heavy Drinking Days per Month
Time Frame: Baseline and Week 8
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Baseline and Week 8
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Percentage of Days Abstinent per Month
Time Frame: Baseline and Week 8
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Baseline and Week 8
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Percentage of Participants with No (0) Heavy Drinking Days per Month
Time Frame: Baseline and Week 8
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Baseline and Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST, Eli Lilly and Company
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
February 21, 2013
First Submitted That Met QC Criteria
February 21, 2013
First Posted (Estimate)
February 25, 2013
Study Record Updates
Last Update Posted (Estimate)
February 3, 2017
Last Update Submitted That Met QC Criteria
February 1, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14792
- I5J-MC-NOAD (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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