Alcohol DependencePhase 2NCT00805441

A Study in the Treatment of Alcohol Dependence.

A Phase 2 study testing LY686017 in people with Alcohol Dependence, run by Eli Lilly and Company at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Alcohol Dependence
What is being tested?: LY686017
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 190 participants
Where: 21 sitesUnited States
Study dates: Dec 2008to Jul 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

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.
Albuquerque, New Mexico, 87102
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.
Austin, Texas, 78756
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.
Boston, Massachusetts, 02118
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.
Canton, Ohio, 44718
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.
Charlottesville, Virginia, 22908
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.
Deerfield Beach, Florida, 33441
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.
DeSoto, Texas, 75115
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.
Havertown, Pennsylvania, 19083
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.
Houston, Texas, 77090
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, 76260
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.
Kirkland, Washington, 98033
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.
Lafayette, Indiana, 47905
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.
Naperville, Illinois, 60563
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.
Nashville, Tennessee, 37232
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, 33161
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.
Oceanside, California, 92056
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.
Oklahoma City, Oklahoma, 73103
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, 97209
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.
San Diego, California, 92103
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.
Seattle, Washington, 98104
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.
Shreveport, Louisiana, 71101

Other trials in United States

About this study

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

Conditions: Alcohol Dependence
Being tested: LY686017, Placebo
Keywords: Alcoholic
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY686017Drug
50 milligrams (mg) daily by oral route for 12 weeks
PlaceboDrug
Daily by oral route for 12 weeks

Study groups in NCT00805441
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
LY686017	Experimental	Not described Receives: Drug: LY686017

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Weeks 4 and 8 and 12 and 16

Secondary outcomes (12)

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.
Measured: Baseline and Weeks 4 and 8 and 12 and 16.
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).
Measured: Baseline and Weeks 4 and 8 and12 and 16
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."
Measured: Baseline up to Week 12
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.
Measured: Baseline, Week 12
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).
Measured: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
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.
Measured: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
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.
Measured: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
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.
Measured: Baseline, Weeks 6 and 12
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Measured: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
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.
Measured: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Jul 2009

First posted9 Dec 2008 (estimated)
Study startDec 2008
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alcohol DependenceStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00805441
Sponsor's protocol ID: 12422
Other IDs: H8R-MC-HJAQ
Status last verified: Sep 2019
First submitted: 5 Dec 2008
Last updated: 17 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder

All Alcohol Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study of LY686017 Compared With Placebo for the Treatment of Alcohol Dependence
ClinicalTrials.gov ID: NCT00805441
Acronym / sponsor ID: 12422
Conditions: Alcohol Dependence
Keywords: Alcoholic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 9 Dec 2008 (estimated)
Results: Posted 13 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
LY686017	Experimental	Drug: LY686017

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY68601750 milligrams (mg) daily by oral route for 12 weeks	Drug	LY686017
PlaceboDaily by oral route for 12 weeks	Drug	Placebo

Primary outcome

Percent Change From Baseline in Heavy Drinking Days
Time frame: Baseline, Weeks 4 and 8 and 12 and 16
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.

12 secondary outcomes

Percent Days Abstinent Per Month
Time frame: Baseline and Weeks 4 and 8 and 12 and 16.
Number of Drinks Per Drinking Day During a Month
Time frame: Baseline and Weeks 4 and 8 and12 and 16
Time to First Heavy Drinking Day
Time frame: Baseline up to Week 12
Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale
Time frame: Baseline, Week 12
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
Time frame: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Time frame: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
Time frame: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
Change From Baseline Beck Anxiety Index (BAI) Total Score
Time frame: Baseline, Weeks 6 and 12
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
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Time frame: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)
Time frame: Baseline and Week 12
12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 13 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY686017	94	60
Placebo	96	60

Primary outcome: Percent Change From Baseline in Heavy Drinking Days

Time frame: Baseline, Weeks 4 and 8 and 12 and 16. Mean (Standard Deviation). Unit: percent of heavy drinking days

Measure	LY686017 n = 91	Placebo n = 90
Week 4	-45.63 (36.58)	-39.72 (36.52)
Week 8	-60.98 (39.25)	-49.88 (48.43)
Week 12	-68.56 (40.01)	-57.44 (42.02)
Week 16	-69.46 (35.84)	-59.12 (40.42)

Population analysed: All randomized participants who received at least one dose of study drug and had daily drinking assessed at both baseline and post-baseline.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY686017	0 of 92 (0%)	73 of 92 (79.3%)	Not reported
Placebo	0 of 91 (0%)	68 of 91 (74.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Alcohol Dependence

Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
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Alcohol Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY686017 in people with Alcohol Dependence, run by Eli Lilly and Company at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Heavy Drinking Days (time frame: Baseline, Weeks 4 and 8 and 12 and 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00805441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.