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A Study of LY2940094 in Participants With Alcohol Dependency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798303
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: LY2940094 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial in Patients With Alcohol Dependence
Study Start Date : July 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY2940094
40 mg LY2940094 oral tablet, QD for 8 weeks
Drug: LY2940094
Administered orally

Placebo Comparator: Placebo
Identically matched placebo oral tablet, QD for 8 weeks
Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. Change from Baseline to Week 8 in the Average Number of Drinks per Day (NDD) Measured Over 28 Days [ Time Frame: Baseline, Week 8 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 8 in Gammaglutamyl Transferase (GGT) [ Time Frame: Baseline, Week 8 ]
  2. Percentage of Heavy Drinking Days per Month [ Time Frame: Baseline and Week 8 ]
  3. Percentage of Days Abstinent per Month [ Time Frame: Baseline and Week 8 ]
  4. Percentage of Participants with No (0) Heavy Drinking Days per Month [ Time Frame: Baseline and Week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798303


Locations
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United States, Connecticut
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.
New Haven, Connecticut, United States, 06519
United States, Florida
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.
North Miami, Florida, United States, 33161
United States, Indiana
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.
Indianapolis, Indiana, United States, 46260
United States, Oregon
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.
Portland, Oregon, United States, 97210
United States, South Carolina
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, 29425
Sponsors and Collaborators
BlackThorn Therapeutics, Inc.
Investigators
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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
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Responsible Party: BlackThorn Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01798303    
Other Study ID Numbers: 14792
I5J-MC-NOAD ( Other Identifier: Eli Lilly and Company )
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders