Trial · NCT01008280

Baclofen to Reduce Alcohol Use in Veterans With HCV

NCT01008280, Phase 4, Completed, VA Office of Research and Development; results first posted 2015-06-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Baclofen to Reduce Alcohol Use in Veterans With HCV. Trials, record NCT01008280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01008280

On this page

Trial

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

Title: Baclofen to Reduce Alcohol Use in Veterans With HCV
NCT number: NCT01008280
Status: Completed
Phases: Phase 4
Enrollment: 180 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Hepatitis C, Alcohol Use Disorders
Interventions: baclofen, placebo
First posted: 2009-11-05
Last updated: 2016-02-08
Results first posted: 2015-06-09

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Number of Drinking Days in the Past Two Weeks	12 Weeks
Primary	Number of Drinks Consumed Per Two Week Segments	12 weeks
Primary	Number of Heavy Drinking Days Per Two Week Segment	12 weeks	A heavy drinking day was defined as ≥4 drinks/ day if female or ≥5 drinks/day if male

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Drinking Days in the Past Two Weeks	12 Weeks	Number of Drinking Days/2 weeks	MEAN
PRIMARY	Number of Drinks Consumed Per Two Week Segments	12 weeks	Number of Drinks/2 Weeks	MEAN
PRIMARY	Number of Heavy Drinking Days Per Two Week Segment	12 weeks	Number of heavy drinking days/2 weeks	MEAN

Source ClinicalTrials.gov

Results by group42

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

Outcome	Group	Category	Value	Spread	Units
Number of Drinking Days in the Past Two Weeks	Baclofen	Baseline	8.6	Standard Error .50	Number of Drinking Days/2 weeks
Number of Drinking Days in the Past Two Weeks	Placebo	Baseline	8.9	Standard Error .45	Number of Drinking Days/2 weeks
Number of Drinking Days in the Past Two Weeks	Baclofen	Weeks 0-1	6.8	Standard Error .55	Number of Drinking Days/2 weeks
Number of Drinking Days in the Past Two Weeks	Placebo	Weeks 0-1	7.1	Standard Error .54	Number of Drinking Days/2 weeks
Number of Drinking Days in the Past Two Weeks	Baclofen	Weeks 2-3	6.2	Standard Error .55	Number of Drinking Days/2 weeks
Number of Drinking Days in the Past Two Weeks	Placebo	Weeks 2-3	6.3	Standard Error .55	Number of Drinking Days/2 weeks
Number of Drinking Days in the Past Two Weeks	Baclofen	Weeks 4-5	5.7	Standard Error .57	Number of Drinking Days/2 weeks
Number of Drinking Days in the Past Two Weeks	Placebo	Weeks 4-5	5.8	Standard Error .58	Number of Drinking Days/2 weeks
Number of Drinking Days in the Past Two Weeks	Baclofen	Weeks 6-7	5.4	Standard Error .57	Number of Drinking Days/2 weeks
Number of Drinking Days in the Past Two Weeks	Placebo	Weeks 6-7	5.4	Standard Error .59	Number of Drinking Days/2 weeks

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Baclofen	88
Overall Study	STARTED	Placebo	92
Overall Study	COMPLETED	Baclofen	67
Overall Study	COMPLETED	Placebo	73
Overall Study	NOT COMPLETED	Baclofen	21
Overall Study	NOT COMPLETED	Placebo	19

Source ClinicalTrials.gov

Adverse events106

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
other	Abdominal Pain	General disorders	Baclofen	12	88
other	Abdominal Pain	General disorders	Placebo	15	92
other	Bedwetting	Renal and urinary disorders	Baclofen	5	88
other	Bedwetting	Renal and urinary disorders	Placebo	1	92
other	Blurred Vision	Eye disorders	Baclofen	9	88
other	Blurred Vision	Eye disorders	Placebo	9	92
other	Confusion	General disorders	Baclofen	20	88
other	Confusion	General disorders	Placebo	14	92
other	Constipation	General disorders	Baclofen	14	88
other	Constipation	General disorders	Placebo	14	92

1 to 10 of 106Source ClinicalTrials.gov

See all 106 adverse events

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	70	88
Total, other adverse events	Placebo	68	92
Total, serious adverse events	Baclofen	6	88
Total, serious adverse events	Placebo	3	92

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01008280

GET https://conductscience.org/api/trials/v1/NCT01008280/results?page=2

API reference For AI assistants