Trial · NCT01573052
Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal
NCT01573052, Phase 4, Completed, VA Salt Lake City Health Care System; results first posted 2020-08-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal. Trials, record NCT01573052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01573052
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal
- NCT number
- NCT01573052
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 26 participants, actual
- Lead sponsor
- VA Salt Lake City Health Care System
- Conditions
- Alcohol Withdrawal
- Interventions
- Chlordiazepoxide, Gabapentin
- First posted
- 2012-04-06
- Last updated
- 2020-08-17
- Results first posted
- 2020-08-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Epworth Sleepiness Scale (ESS) | 1 week | ESS is an 8 item-scale and scores range between 0 and 24. The higher the score implies more daytime sleepiness. |
| Primary | PENN Alcohol Craving Scale | 1 week | PENN is a 5 item self-rated scale of alcohol craving. Scores range from 0 (little craving for alcohol) to 30 (irresistable urge to drink alcohol) |
| Secondary | Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar) | 1 week | CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Many previously publications suggest a total score of 8-10 is severe enough to warrant medication treatment. Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores \> 8 represent more withdrawal symptoms and greater severity |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Epworth Sleepiness Scale (ESS) | 1 week | Late withdrawal period days 5-7 | units on a scale | MEAN |
| PRIMARY | PENN Alcohol Craving Scale | 1 week | Late withdrawal period days 5-7 | units on a scale | MEAN |
| SECONDARY | Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar) | 1 week | Late withdrawal period days 5-7 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Epworth Sleepiness Scale (ESS) | Chlordiazepoxide | 6.35 | 95% Confidence Interval 3.13 to 9.57 | units on a scale | |
| Epworth Sleepiness Scale (ESS) | Gabapentin | 2.65 | 95% Confidence Interval 0.44 to 4.85 | units on a scale | |
| PENN Alcohol Craving Scale | Chlordiazepoxide | 16.78 | 95% Confidence Interval 10.92 to 22.64 | units on a scale | |
| PENN Alcohol Craving Scale | Gabapentin | 10.74 | 95% Confidence Interval 7.09 to 14.39 | units on a scale | |
| Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar) | Chlordiazepoxide | 3.29 | 95% Confidence Interval -0.28 to 6.88 | units on a scale | |
| Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar) | Gabapentin | 4.33 | 95% Confidence Interval 2.10 to 6.56 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chlordiazepoxide | 9 | |
| Overall Study | STARTED | Gabapentin | 17 | |
| Overall Study | COMPLETED | Chlordiazepoxide | 6 | |
| Overall Study | COMPLETED | Gabapentin | 11 | |
| Overall Study | NOT COMPLETED | Chlordiazepoxide | 3 | |
| Overall Study | NOT COMPLETED | Gabapentin | 6 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chlordiazepoxide | ||
| Total, all-cause mortality | Gabapentin | ||
| Total, other adverse events | Chlordiazepoxide | 0 | 9 |
| Total, other adverse events | Gabapentin | 0 | 17 |
| Total, serious adverse events | Chlordiazepoxide | 0 | 9 |
| Total, serious adverse events | Gabapentin | 0 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23780805 | DERIVED |
Source PubMed
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 |
|---|
| Chlordiazepoxide vs Gabapentin: 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.
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/NCT01573052
GET https://conductscience.org/api/trials/v1/NCT01573052/registered