A Study of LY2940094 in Participants With Alcohol Dependency

Alcoholism Clinical Trial

Official title:

Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial in Patients With Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798303
• Other study ID #: 14792
• Secondary ID: I5J-MC-NOAD
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2013
• Last updated: February 1, 2017
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: February 2017
• Source: BlackThorn Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• LY2940094
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
United States	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	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	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	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	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

Sponsors (1)

Lead Sponsor	Collaborator
BlackThorn Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Week 8 in the Average Number of Drinks per Day (NDD) Measured Over 28 Days		Baseline, Week 8
Secondary	Change from Baseline to Week 8 in Gammaglutamyl Transferase (GGT)		Baseline, Week 8
Secondary	Percentage of Heavy Drinking Days per Month		Baseline and Week 8
Secondary	Percentage of Days Abstinent per Month		Baseline and Week 8
Secondary	Percentage of Participants with No (0) Heavy Drinking Days per Month		Baseline and Week 8