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Trial · NCT01187511

CRF1 Antagonist GSK561679 in Alcoholism

NCT01187511, Phase 2, Completed, National Institute on Alcohol Abuse and Alcoholism (NIAAA); results first posted 2016-11-07

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. CRF1 Antagonist GSK561679 in Alcoholism. Trials, record NCT01187511. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01187511

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
CRF1 Antagonist GSK561679 in Alcoholism
NCT number
NCT01187511
Status
Completed
Phases
Phase 2
Enrollment
44 participants, actual
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
Alcohol Dependence
Interventions
GSK561679, Placebo
First posted
2010-08-24
Last updated
2016-11-07
Results first posted
2016-11-07

Source ClinicalTrials.gov

Registered outcomes51

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAlcohol Craving in Response to the Alcohol Cue Script15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
PrimaryAlcohol Craving in Response to the Alcohol Cue Script15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
PrimaryAlcohol Craving in Response to the Alcohol Cue Script30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
PrimaryAlcohol Craving in Response to the Alcohol Cue Script45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
PrimaryAlcohol Craving in Response to the Alcohol Cue Script5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
PrimaryAlcohol Craving in Response to the Alcohol Cue Script60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
PrimaryAlcohol Craving in Response to the Alcohol Cue Script75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
PrimaryAlcohol Craving in Response to the Alcohol Cue Script90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
PrimaryAlcohol Craving in Response to the Stress Script15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
PrimaryAlcohol Craving in Response to the Stress Script15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcomes51

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYAlcohol Craving in Response to the Alcohol Cue Script15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment periodThe analyses included only those subjects who completed all three script types (neutral, alcohol, stress)Units on a scaleLEAST_SQUARES_MEAN
PRIMARYAlcohol Craving in Response to the Alcohol Cue Script15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment periodThe analyses included only those subjects who completed all three script types (neutral, alcohol, stress)Units on a scaleLEAST_SQUARES_MEAN
PRIMARYAlcohol Craving in Response to the Alcohol Cue Script30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment periodThe analyses included only those subjects who completed all three script types (neutral, alcohol, stress)Units on a scaleLEAST_SQUARES_MEAN
PRIMARYAlcohol Craving in Response to the Alcohol Cue Script45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment periodThe analyses included only those subjects who completed all three script types (neutral, alcohol, stress)Units on a scaleLEAST_SQUARES_MEAN
PRIMARYAlcohol Craving in Response to the Alcohol Cue Script5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment periodThe analyses included only those subjects who completed all three script types (neutral, alcohol, stress)Units on a scaleLEAST_SQUARES_MEAN
PRIMARYAlcohol Craving in Response to the Alcohol Cue Script60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment periodThe analyses included only those subjects who completed all three script types (neutral, alcohol, stress)Units on a scaleLEAST_SQUARES_MEAN
PRIMARYAlcohol Craving in Response to the Alcohol Cue Script75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment periodThe analyses included only those subjects who completed all three script types (neutral, alcohol, stress)Units on a scaleLEAST_SQUARES_MEAN
PRIMARYAlcohol Craving in Response to the Alcohol Cue Script90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment periodThe analyses included only those subjects who completed all three script types (neutral, alcohol, stress)Units on a scaleLEAST_SQUARES_MEAN
PRIMARYAlcohol Craving in Response to the Stress Script15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment periodThe analyses included only those subjects who completed all three script types (neutral, alcohol, stress)Units on a scaleLEAST_SQUARES_MEAN
PRIMARYAlcohol Craving in Response to the Stress Script15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment periodThe analyses included only those subjects who completed all three script types (neutral, alcohol, stress)Units on a scaleLEAST_SQUARES_MEAN

Results by group102

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Alcohol Craving in Response to the Alcohol Cue ScriptGSK56167911.6932Standard Error 1.6713Units on a scale
Alcohol Craving in Response to the Alcohol Cue ScriptPlacebo14.6126Standard Error 1.2775Units on a scale
Alcohol Craving in Response to the Alcohol Cue ScriptGSK5616798.7646Standard Error 1.6713Units on a scale
Alcohol Craving in Response to the Alcohol Cue ScriptPlacebo10.413Standard Error 1.295Units on a scale
Alcohol Craving in Response to the Alcohol Cue ScriptGSK56167911.4075Standard Error 1.6713Units on a scale
Alcohol Craving in Response to the Alcohol Cue ScriptPlacebo13.0412Standard Error 1.2775Units on a scale
Alcohol Craving in Response to the Alcohol Cue ScriptGSK5616799.6218Standard Error 1.6713Units on a scale
Alcohol Craving in Response to the Alcohol Cue ScriptPlacebo12.1841Standard Error 1.2775Units on a scale
Alcohol Craving in Response to the Alcohol Cue ScriptGSK56167913.9789Standard Error 1.6713Units on a scale
Alcohol Craving in Response to the Alcohol Cue ScriptPlacebo15.946Standard Error 1.2775Units on a scale

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDGSK56167922
Overall StudySTARTEDPlacebo22
Overall StudyCOMPLETEDGSK56167914
Overall StudyCOMPLETEDPlacebo21
Overall StudyNOT COMPLETEDGSK5616798
Overall StudyNOT COMPLETEDPlacebo1

Adverse events38

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherConstipationGastrointestinal disordersGSK561679022
otherConstipationGastrointestinal disordersPlacebo222
otherDiarrheaGastrointestinal disordersGSK561679722
otherDiarrheaGastrointestinal disordersPlacebo722
otherHeartburnGastrointestinal disordersGSK561679122
otherHeartburnGastrointestinal disordersPlacebo122
otherNauseaGastrointestinal disordersGSK561679922
otherNauseaGastrointestinal disordersPlacebo722
otherStomach painGastrointestinal disordersGSK561679722
otherStomach painGastrointestinal disordersPlacebo1022

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityGSK561679
Total, all-cause mortalityPlacebo
Total, other adverse eventsGSK5616792222
Total, other adverse eventsPlacebo2222
Total, serious adverse eventsGSK561679022
Total, serious adverse eventsPlacebo022

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
16545872BACKGROUNDPubMed
17019567BACKGROUNDPubMed
17629579BACKGROUNDPubMed

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
GSK561679 vs Placebo: serious adverse events

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed as
Food Cue Reactivity TaskSecondary outcome

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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/NCT01187511

GET https://conductscience.org/api/trials/v1/NCT01187511/registered?page=2