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OpenTrials
Completed

NCT Number: NCT01798303

A Study of LY2940094 in Participants With Alcohol Dependency

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2940094

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

BlackThorn Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 25, 2013
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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