Trial · NCT00804570
A Study for the Treatment of Alcohol Dependence
NCT00804570, Phase 2, Completed, Eli Lilly and Company; results first posted 2017-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study for the Treatment of Alcohol Dependence. Trials, record NCT00804570. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00804570
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for the Treatment of Alcohol Dependence
- NCT number
- NCT00804570
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 375 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Alcohol Dependence
- Interventions
- LY2196044, placebo
- First posted
- 2008-12-09
- Last updated
- 2019-09-24
- Results first posted
- 2017-02-03
- Limitations and caveats
Based on exposure data from an Alcohol Interaction study, H9T-MC-NABL (unregistered Phase 1 trial), the maximum dose in this study was reduced from 250 mg to 125 mg of LY2196044 after about 2/3 into the conduct of the trial.
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Heavy Drinking Days at Week 16 Endpoint | Week 16 | The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment\*visit, gender\*family history, baseline, and baseline\*visit. An unstructured covariance structure was used. |
| Secondary | Change From Baseline in Drinks Per Day at Week 16 Endpoint | Baseline, Week 16 | The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed per day. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment\*visit, gender\*family history, baseline, and baseline\*visit. An unstructured covariance structure was used. |
| Secondary | Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint | Baseline, Week 16 | The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the percentage of days abstinent. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment\*visit, gender\*family history, baseline, and baseline\*visit. An unstructured covariance structure was used. |
| Secondary | Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint | Baseline, Week 16 | The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on the days the participant drank. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment\*visit, gender\*family history, baseline, and baseline\*visit. An unstructured covariance structure was used. |
| Secondary | Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint | Baseline, Week 16 | The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment\*visit, gender\*family history, baseline, and baseline\*visit. An unstructured covariance structure was used. |
| Secondary | Change From Baseline in Obsessive Compulsive Drinking Scale (OCDS) Total Score at Week 16 Endpoint | Baseline, Week 16 | Cravings will be assessed using the OCDS. The OCDS is a 14-item self-rating instrument. Total scores range from 0-40. Higher scores indicate more obsessive and craving. Least Squares (LS) Mean value was controlled for treatment, site, visit, gender, history, baseline, gender\*history, treatment\*visit, baseline\*visit, gender\*treatment, gender\*treatment\*visit. Subject was treated as a random effect. An unstructured covariance structure was used. |
| Secondary | Change From Baseline in Drinker Inventory of Consequences (DrInC) - Recent Consequences (DrInC-2R) Total Score at Week 16 Endpoint | Baseline, Week 16 | 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. DrInC-2R provides a measurement since the last interview. Total scores range from 0-150, and higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender\*family history, treatment\*visit, baseline\*visit. Subject was treated as a random effect. An unstructured covariance structure was used. |
| Secondary | Ratio of Geometric Means Over Baseline in Gamma-Glutamyltransferase (GGT) Level at Week 16 Endpoint | Week 16 | GGT and carbohydrate-deficient transferrin (%CDT) will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender\*family history, treatment\*visit, baseline\*visit. An unstructured covariance structure was used. |
| Secondary | Ratio of Geometric Means Over Baseline in Percent Carbohydrate-Deficient Transferrin (%CDT) Level at Week 16 Endpoint | Week 16 | Gamma-Glutamyltransferase (GGT) and %CDT will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender\*family history, treatment\*visit, baseline\*visit. An unstructured covariance structure was used. |
| Secondary | Ratio of Geometric Means Over Baseline in Aspartate Transaminase (AST) Level at Week 16 Endpoint | Week 16 | AST is a potential biomarker for LY2196044 efficacy as decreases reflect decreased alcohol consumption. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender\*family history, treatment\*visit, baseline\*visit. An unstructured covariance structure was used. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Heavy Drinking Days at Week 16 Endpoint | Week 16 | Participants with a baseline and post-baseline value. | percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Drinks Per Day at Week 16 Endpoint | Baseline, Week 16 | Participants with a baseline and post-baseline value. | number of drinks/day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint | Baseline, Week 16 | Participants with a baseline and post-baseline value. | percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint | Baseline, Week 16 | Participants with a baseline and post-baseline value. | number of drinks/drinking day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint | Baseline, Week 16 | Participants with a baseline and post-baseline value. | number of drinks/heavy drinking day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Obsessive Compulsive Drinking Scale (OCDS) Total Score at Week 16 Endpoint | Baseline, Week 16 | Participants with a baseline and post-baseline value. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Drinker Inventory of Consequences (DrInC) - Recent Consequences (DrInC-2R) Total Score at Week 16 Endpoint | Baseline, Week 16 | Participants with a baseline and post-baseline value. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Ratio of Geometric Means Over Baseline in Gamma-Glutamyltransferase (GGT) Level at Week 16 Endpoint | Week 16 | Participants with a baseline and post-baseline value. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Ratio of Geometric Means Over Baseline in Percent Carbohydrate-Deficient Transferrin (%CDT) Level at Week 16 Endpoint | Week 16 | Participants with a baseline and post-baseline value. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Ratio of Geometric Means Over Baseline in Aspartate Transaminase (AST) Level at Week 16 Endpoint | Week 16 | Participants with a baseline and post-baseline value. | ratio | GEOMETRIC_MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Heavy Drinking Days at Week 16 Endpoint | LY2196044 | -43.02 | Standard Error 2.09 | percentage of days | |
| Percentage of Heavy Drinking Days at Week 16 Endpoint | Placebo | -38.72 | Standard Error 2.12 | percentage of days | |
| Change From Baseline in Drinks Per Day at Week 16 Endpoint | LY2196044 | -5.37 | Standard Error 0.22 | number of drinks/day | |
| Change From Baseline in Drinks Per Day at Week 16 Endpoint | Placebo | -4.66 | Standard Error 0.22 | number of drinks/day | |
| Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint | LY2196044 | 33.49 | Standard Error 2.05 | percentage of days | |
| Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint | Placebo | 28.12 | Standard Error 2.09 | percentage of days | |
| Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint | LY2196044 | -3.77 | Standard Error 0.26 | number of drinks/drinking day | |
| Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint | Placebo | -3.38 | Standard Error 0.26 | number of drinks/drinking day | |
| Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint | LY2196044 | -2.61 | Standard Error 0.26 | number of drinks/heavy drinking day | |
| Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint | Placebo | -2.17 | Standard Error 0.26 | number of drinks/heavy drinking day |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LY2196044 | 187 | |
| Overall Study | STARTED | Placebo | 188 | |
| Overall Study | COMPLETED | LY2196044 | 115 | |
| Overall Study | COMPLETED | Placebo | 94 | |
| Overall Study | NOT COMPLETED | LY2196044 | 72 | |
| Overall Study | NOT COMPLETED | Placebo | 94 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | LY2196044 | 12 | 187 | 12 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 2 | 188 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | LY2196044 | 19 | 187 | 22 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 6 | 188 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | LY2196044 | 11 | 187 | 13 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 3 | 188 | 4 |
| other | Constipation | Gastrointestinal disorders | LY2196044 | 12 | 187 | 13 |
| other | Constipation | Gastrointestinal disorders | Placebo | 3 | 188 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | LY2196044 | 36 | 187 | 39 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 16 | 188 | 17 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2196044 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | LY2196044 | 143 | 187 |
| Total, other adverse events | Placebo | 116 | 188 |
| Total, serious adverse events | LY2196044 | 4 | 187 |
| Total, serious adverse events | Placebo | 5 | 188 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LY2196044 vs Placebo: Number of Participants With Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)≥10 at Any Time From Baseline Through Week 16 Endpoint | Trial comparisons |
| LY2196044 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00804570
GET https://conductscience.org/api/trials/v1/NCT00804570/registered?page=2