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A Study in the Treatment of Alcohol Dependence.

Primary Purpose

Alcohol Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LY686017

Placebo

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcoholic

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have Alcohol Dependence.
Are men or women who are ambulatory outpatients between 21 to 65 years of age (inclusive) showing evidence of living in a non-custodial stable residence and with no plans to move during the next 5 months.
Females of childbearing potential (not surgically sterilized and between menopause) must test negative for pregnancy at the time of enrollment based on a pregnancy test. They must agree to use a reliable method of birth control during the study and for 2 months following the last dose of study drug.
Drink on average more than 14 drinks (women) or 21 drinks (men) per week with at least 2 heavy drinking days per week.
Endorse abstinence or reduction in drinking as an interim goal toward abstinence.

Exclusion Criteria:

Are investigator site personnel directly affiliated with this study and/or their immediate families.
Are Lilly employees.
Are currently enrolled in or discontinued within the last 30 days from a clinical trial.
Have experienced an acute alcohol withdrawal syndrome within the past 6 months or are currently or during this study at significant risk of suffering an acute alcohol withdrawal syndrome.
Have a history of serious head injury, neoplasm or hemorrhage, prior seizure (other than a history of childhood febrile seizure), or other condition that would place the subject at increased risk for seizures.
Are taking or have taken anticonvulsant medications for seizures.
Are diagnosed with substance dependence or substance abuse other than alcohol, cannabis, nicotine, or caffeine within 12 months prior to first visit.
Are receiving medications or intensive behavioral or psychological therapy delivered by a licensed or certified alcohol treatment specialist for alcohol dependence.
Have signs and symptoms or an active illness within the past 2 weeks of first visit that meet criteria diagnosis of Major Depressive Disorder. In addition, meet criteria as diagnosis for any comorbid Axis I disorders (such as anxiety disorders, obsessive compulsive disorder (OCD), Posttraumatic stress disorder (PTSD), panic disorder, or dysthymia).
Have a positive urine drug screen for any non-prescribed substances of abuse.
Have a serious medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, or neurological disease, or any clinically significant laboratory abnormality.
Ever had electroconvulsive therapy (ECT).
Have abnormal thyroid stimulating hormone (TSH) concentrations or are taking thyroid supplements.
Have a history of cirrhosis or laboratory evidence of hepatocellular injury.
An abnormality in serum Prothrombin time.
Are unable to make themselves available for the duration of the study or abide by study procedures and restrictions.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

LY686017

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Heavy Drinking Days

The Alcohol Timeline Followback (TLFB) is used in calculating the percent reduction in heavy drinking days. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day during last 4 weeks. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.

Secondary Outcome Measures

Percent Days Abstinent Per Month

The Alcohol Timeline Followback (TLFB) is used in calculating the percentage of days abstinent (days where no alcoholic drinks were consumed). The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Percentage days per month= (number of days where no alcoholic beverages were consumed/number of days in a month)*100.

Number of Drinks Per Drinking Day During a Month

The Alcohol Timeline Followback (TLFB) is used in calculating the number of drinks per drinking day. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv).

Time to First Heavy Drinking Day

The Alcohol Timeline Followback (TLFB) is used to assess the time to first heavy drinking day. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men. Those who did not drink are considered to be "censored."

Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale

DrInC is a self-administered, 50-item questionnaire designed to measure adverse consequences of alcohol abuse in 5 areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. All items for the DrInC are scored from 0-3 with higher scores indicating worse adverse consequences. Interpersonal subscale (10 items: scores range from 0-30) measures the impact of drinking on the participants' relationships. Physical subscale (8 items: scores range from 0-24) measures adverse physical states resulting from excessive drinking. Social subscale (7 items: scores range from 0-21) measures role fulfillment. Impulsive subscale (12 items: scores range from 0-36) measures sequelae of over drinking. Intrapersonal subscale (8 items: scores range from 0-24) measures subjective perceptions that may not be readily observable by others. Total scores range from 0-150, with higher scores indicating greater severity of symptoms.

Change From Baseline in Alcohol Urge Questionnaire (AUQ)

AUQ measures participant's feeling and thoughts about drinking, and uses a 7 point (1-7) Likert scale for each of 8 items (questions). Scores range from 8 (less urge to drink) to 56 (more urge to drink).

Change From Baseline in Penn Alcohol Craving Scale (PACS)

PACS is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, ability to resist drinking and craving. Each item ranges from 0-6 with 6 indicating worse symptoms.

Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score

BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. There is a 4-point scale for each item ranging from 0 (no depression) to 3 (very depressed). Total scores range from 0-63. Higher scores indicate greater severity of depression.

Change From Baseline Beck Anxiety Index (BAI) Total Score

BAI is a 21-item participant-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0= not present; 3= present in the extreme). Total scores range from 0 to 63. Higher total scores indicate greater severity of anxiety symptoms.

Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)

Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)

Carbohydrate Deficient Transferrin is a laboratory test that measures alcohol consumption. Greater levels suggest recent alcohol consumption.

12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)

Short Form 12 (SF-12) is a 12-item assessment used to measure participant's physical wellbeing [physical component score (PCS)] and mental wellbeing [mental component score (MCS)]. The PCS score ranges from 0 (lowest wellbeing) to 100 (highest wellbeing) and is designed to have a mean of 50 and standard deviation (SD) of 10 in the general population.

12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)

Short Form 12 (SF-12) is a 12-item assessment used to measure participant's physical wellbeing [physical component score (PCS)] and mental wellbeing [mental component score (MCS)]. The MCS score ranges from 0 (lowest wellbeing) to 100 (highest wellbeing) and is designed to have a mean of 50 and standard deviation (SD) of 10 in the general population.

Full Information

NCT ID

NCT00805441

First Posted

December 5, 2008

Last Updated

September 9, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00805441

Brief Title

A Study in the Treatment of Alcohol Dependence.

Official Title

A Phase 2 Study of LY686017 Compared With Placebo for the Treatment of Alcohol Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

H8R-MC-HJAQ is a Phase 2, parallel, double-blind, randomized study comparing LY686017 with placebo in a 12-week trial that includes Medical Management. This study is an outpatient study in which approximately 180 alcohol dependent subjects will be enrolled. Subjects will be randomized in a 1:1 fashion to LY686017 or placebo, and will receive once daily dosing for twelve weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence

Keywords

Alcoholic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

190 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

LY686017

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

LY686017

Intervention Description

50 milligrams (mg) daily by oral route for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Daily by oral route for 12 weeks

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Heavy Drinking Days

Description

Time Frame

Baseline, Weeks 4 and 8 and 12 and 16

Secondary Outcome Measure Information:

Title

Percent Days Abstinent Per Month

Description

Time Frame

Baseline and Weeks 4 and 8 and 12 and 16.

Title

Number of Drinks Per Drinking Day During a Month

Description

Time Frame

Baseline and Weeks 4 and 8 and12 and 16

Title

Time to First Heavy Drinking Day

Description

Time Frame

Baseline up to Week 12

Title

Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Alcohol Urge Questionnaire (AUQ)

Description

Time Frame

Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12

Title

Change From Baseline in Penn Alcohol Craving Scale (PACS)

Description

Time Frame

Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12

Title

Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score

Description

Time Frame

Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12

Title

Change From Baseline Beck Anxiety Index (BAI) Total Score

Description

Time Frame

Baseline, Weeks 6 and 12

Title

Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)

Time Frame

Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12

Title

Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)

Description

Carbohydrate Deficient Transferrin is a laboratory test that measures alcohol consumption. Greater levels suggest recent alcohol consumption.

Time Frame

Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12

Title

12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)

Description

Time Frame

Baseline and Week 12

Title

12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)

Description

Short Form 12 (SF-12) is a 12-item assessment used to measure participant's physical wellbeing [physical component score (PCS)] and mental wellbeing [mental component score (MCS)]. The MCS score ranges from 0 (lowest wellbeing) to 100 (highest wellbeing) and is designed to have a mean of 50 and standard deviation (SD) of 10 in the general population.

Time Frame

Baseline and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have Alcohol Dependence. Are men or women who are ambulatory outpatients between 21 to 65 years of age (inclusive) showing evidence of living in a non-custodial stable residence and with no plans to move during the next 5 months. Females of childbearing potential (not surgically sterilized and between menopause) must test negative for pregnancy at the time of enrollment based on a pregnancy test. They must agree to use a reliable method of birth control during the study and for 2 months following the last dose of study drug. Drink on average more than 14 drinks (women) or 21 drinks (men) per week with at least 2 heavy drinking days per week. Endorse abstinence or reduction in drinking as an interim goal toward abstinence. Exclusion Criteria: Are investigator site personnel directly affiliated with this study and/or their immediate families. Are Lilly employees. Are currently enrolled in or discontinued within the last 30 days from a clinical trial. Have experienced an acute alcohol withdrawal syndrome within the past 6 months or are currently or during this study at significant risk of suffering an acute alcohol withdrawal syndrome. Have a history of serious head injury, neoplasm or hemorrhage, prior seizure (other than a history of childhood febrile seizure), or other condition that would place the subject at increased risk for seizures. Are taking or have taken anticonvulsant medications for seizures. Are diagnosed with substance dependence or substance abuse other than alcohol, cannabis, nicotine, or caffeine within 12 months prior to first visit. Are receiving medications or intensive behavioral or psychological therapy delivered by a licensed or certified alcohol treatment specialist for alcohol dependence. Have signs and symptoms or an active illness within the past 2 weeks of first visit that meet criteria diagnosis of Major Depressive Disorder. In addition, meet criteria as diagnosis for any comorbid Axis I disorders (such as anxiety disorders, obsessive compulsive disorder (OCD), Posttraumatic stress disorder (PTSD), panic disorder, or dysthymia). Have a positive urine drug screen for any non-prescribed substances of abuse. Have a serious medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, or neurological disease, or any clinically significant laboratory abnormality. Ever had electroconvulsive therapy (ECT). Have abnormal thyroid stimulating hormone (TSH) concentrations or are taking thyroid supplements. Have a history of cirrhosis or laboratory evidence of hepatocellular injury. An abnormality in serum Prothrombin time. Are unable to make themselves available for the duration of the study or abide by study procedures and restrictions.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

City

Deerfield Beach

State/Province

Florida

ZIP/Postal Code

33441

Country

United States

Facility Name

City

North Miami

State/Province

Florida

ZIP/Postal Code

33161

Country

United States

Facility Name

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60563

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

76260

Country

United States

Facility Name

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47905

Country

United States

Facility Name

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97209

Country

United States

Facility Name

City

Havertown

State/Province

Pennsylvania

ZIP/Postal Code

19083

Country

United States

Facility Name

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

City

DeSoto

State/Province

Texas

ZIP/Postal Code

75115

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98033

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Learn more about this trial

A Study in the Treatment of Alcohol Dependence.

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