Trial · NCT01227980
Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^
NCT01227980, Phase 2, Completed, National Institute on Alcohol Abuse and Alcoholism (NIAAA); results first posted 2015-12-10
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^. Trials, record NCT01227980. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01227980
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^
- NCT number
- NCT01227980
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Conditions
- Alcohol-Related Disorders, Alcohol Dependence, Alcoholism, Anxiety Disorder
- Interventions
- Pexacerfont, Placebo
- First posted
- 2010-10-25
- Last updated
- 2016-02-02
- Results first posted
- 2015-12-10
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Alcohol Craving in Response to the Alcohol Cue Script | 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 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). |
| Primary | Alcohol Craving in Response to the Alcohol Cue Script | 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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). |
| Primary | Alcohol Craving in Response to the Alcohol Cue Script | 15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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). |
| Primary | Alcohol Craving in Response to the Alcohol Cue Script | 30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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). |
| Primary | Alcohol Craving in Response to the Alcohol Cue Script | 45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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). |
| Primary | Alcohol Craving in Response to the Alcohol Cue Script | 60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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). |
| Primary | Alcohol Craving in Response to the Alcohol Cue Script | 75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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). |
| Primary | Alcohol Craving in Response to the Alcohol Cue Script | 90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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). |
| Primary | Alcohol Craving in Response to the Stress Script | 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 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). |
| Primary | Alcohol Craving in Response to the Stress Script | 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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). |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Alcohol Craving in Response to the Alcohol Cue Script | 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Units on a scale | MEAN |
| PRIMARY | Alcohol Craving in Response to the Alcohol Cue Script | 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | units on a scale | MEAN |
| PRIMARY | Alcohol Craving in Response to the Alcohol Cue Script | 15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | Units on a scale | MEAN |
| PRIMARY | Alcohol Craving in Response to the Alcohol Cue Script | 30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | units on a scale | MEAN |
| PRIMARY | Alcohol Craving in Response to the Alcohol Cue Script | 45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | units on a scale | MEAN |
| PRIMARY | Alcohol Craving in Response to the Alcohol Cue Script | 60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | units on a scale | MEAN |
| PRIMARY | Alcohol Craving in Response to the Alcohol Cue Script | 75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | units on a scale | MEAN |
| PRIMARY | Alcohol Craving in Response to the Alcohol Cue Script | 90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | units on a scale | MEAN |
| PRIMARY | Alcohol Craving in Response to the Stress Script | 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | units on a scale | MEAN |
| PRIMARY | Alcohol Craving in Response to the Stress Script | 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period | The analyses included only those subjects who completed all three script types (neutral, alcohol, stress) | units on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Alcohol Craving in Response to the Alcohol Cue Script | Pexacerfont | 12.7 | Standard Error 2.48 | Units on a scale | |
| Alcohol Craving in Response to the Alcohol Cue Script | Placebo | 10.7 | Standard Error 2.60 | Units on a scale | |
| Alcohol Craving in Response to the Alcohol Cue Script | Pexacerfont | 18.7 | Standard Error 2.48 | units on a scale | |
| Alcohol Craving in Response to the Alcohol Cue Script | Placebo | 14.5 | Standard Error 2.6 | units on a scale | |
| Alcohol Craving in Response to the Alcohol Cue Script | Pexacerfont | 16.6 | Standard Error 2.48 | Units on a scale | |
| Alcohol Craving in Response to the Alcohol Cue Script | Placebo | 12.9 | Standard Error 2.6 | Units on a scale | |
| Alcohol Craving in Response to the Alcohol Cue Script | Pexacerfont | 16.5 | Standard Error 2.48 | units on a scale | |
| Alcohol Craving in Response to the Alcohol Cue Script | Placebo | 11.8 | Standard Error 2.6 | units on a scale | |
| Alcohol Craving in Response to the Alcohol Cue Script | Pexacerfont | 15 | Standard Error 2.48 | units on a scale | |
| Alcohol Craving in Response to the Alcohol Cue Script | Placebo | 12.1 | Standard Error 2.6 | units on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pexacerfont | 40 | |
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | Scripts Challenge Sessions | Pexacerfont | 26 | |
| Overall Study | Scripts Challenge Sessions | Placebo | 25 | |
| Overall Study | Measure Drug Level Concentration | Pexacerfont | 10 | |
| Overall Study | Measure Drug Level Concentration | Placebo | 0 | |
| Overall Study | COMPLETED | Pexacerfont | 38 | |
| Overall Study | COMPLETED | Placebo | 25 | |
| Overall Study | NOT COMPLETED | Pexacerfont | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events32
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 pain | Gastrointestinal disorders | Pexacerfont | 2 | 40 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 30 | |
| other | Nausea | Gastrointestinal disorders | Pexacerfont | 9 | 40 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 11 | 30 | |
| other | Toothache | Gastrointestinal disorders | Pexacerfont | 0 | 40 | |
| other | Toothache | Gastrointestinal disorders | Placebo | 2 | 30 | |
| other | Vomiting | Gastrointestinal disorders | Pexacerfont | 3 | 40 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 2 | 30 | |
| other | Fatigue | General disorders | Pexacerfont | 29 | 40 | |
| other | Fatigue | General disorders | Placebo | 24 | 30 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pexacerfont | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pexacerfont | 34 | 40 |
| Total, other adverse events | Placebo | 28 | 30 |
| Total, serious adverse events | Pexacerfont | 0 | 40 |
| Total, serious adverse events | Placebo | 0 | 30 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Pexacerfont vs Placebo: serious adverse events |
Source 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.
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/NCT01227980
GET https://conductscience.org/api/trials/v1/NCT01227980/results?page=2