Trial · NCT00597701
Treating Alcohol Withdrawal With Oral Baclofen
NCT00597701, Not applicable, Completed, Essentia Health; results first posted 2011-07-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treating Alcohol Withdrawal With Oral Baclofen. Trials, record NCT00597701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00597701
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treating Alcohol Withdrawal With Oral Baclofen
- NCT number
- NCT00597701
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 79 participants, actual
- Lead sponsor
- Essentia Health
- Conditions
- Alcohol Withdrawal Delirium
- Interventions
- Baclofen, Placebo, Lorazepam
- First posted
- 2008-01-18
- Last updated
- 2011-07-27
- Results first posted
- 2011-07-26
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups | From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed. | In acutely-withdrawing alcoholic patients treated with either baclofen or placebo, symptom-driven benzodiazepine doses were assessed for the 72 hours following the first Clinical Institute Withdrawal Assessment (CIWA) score of 11 or greater. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups | From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed. | mg of benzodiazepine per 8 hours | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups | Baclofen | 14.1 | Standard Deviation 8.9 | mg of benzodiazepine per 8 hours | |
| Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups | Placebo | 124.4 | Standard Deviation 290.3 | mg of benzodiazepine per 8 hours |
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 | Baclofen | 25 | |
| Overall Study | STARTED | Placebo | 21 | |
| Overall Study | COMPLETED | Baclofen | 18 | |
| Overall Study | COMPLETED | Placebo | 13 | |
| Overall Study | NOT COMPLETED | Baclofen | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Rapid progression of complications of alcoholism | General disorders | Baclofen | 2 | 25 | 2 |
| serious | Rapid progression of complications of alcoholism | General disorders | Placebo | 1 | 19 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baclofen | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Baclofen | 0 | 25 |
| Total, other adverse events | Placebo | 0 | 19 |
| Total, serious adverse events | Baclofen | 2 | 25 |
| Total, serious adverse events | Placebo | 1 | 19 |
Source ClinicalTrials.gov
Papers2
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 |
|---|
| Baclofen 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.
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/NCT00597701
GET https://conductscience.org/api/trials/v1/NCT00597701/registered