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A Study of LY2940094 in Participants With Alcohol Dependency

B

BlackThorn Therapeutics

Status and phase

Completed
Phase 2

Conditions

Alcoholism

Treatments

Drug: Placebo
Drug: LY2940094

Study type

Interventional

Funder types

Industry

Identifiers

NCT01798303
I5J-MC-NOAD (Other Identifier)
14792

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

88 participants in 2 patient groups, including a placebo group

LY2940094
Experimental group
Description:
40 mg LY2940094 oral tablet, QD for 8 weeks
Treatment:
Drug: LY2940094
Placebo
Placebo Comparator group
Description:
Identically matched placebo oral tablet, QD for 8 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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