Trial · NCT01980706

Efficacy and Safety of High Dose Baclofen for Alcohol Dependence

NCT01980706, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2019-01-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of High Dose Baclofen for Alcohol Dependence. Trials, record NCT01980706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01980706

On this page

Trial

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

Title: Efficacy and Safety of High Dose Baclofen for Alcohol Dependence
NCT number: NCT01980706
Status: Completed
Phases: Phase 2
Enrollment: 120 participants, actual
Lead sponsor: University of North Carolina, Chapel Hill
Conditions: Alcoholism
Interventions: Baclofen, Placebo
First posted: 2013-11-11
Last updated: 2019-06-12
Results first posted: 2019-01-08

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Mean Percentage of Heavy Drinking Days	Every 1-2 weeks up to 16 weeks of active trial	The frequency of heavy drinking days (5 or more drinks for a man and 4 or more drinks for a woman) as percentage during the treatment phase.
Primary	Mean Percentage of Abstinent Drinking Days	Every 1-2 weeks up to 16 weeks of active trial	Percent of abstinent days over the course of the trial.
Secondary	Mean Spielberger State-Trait Anxiety Inventory Score [State]	Every 1-2 weeks up to 16 weeks of active trial	The Spielberger State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults.The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The State scale consists of 20 questions, each question rated 1-4, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety). The scores are averaged over the trial.
Secondary	Mean Penn Alcohol Craving Scale Score	Every 1-2 weeks up to 16 weeks of active trial	Penn Alcohol Craving Scale (PACS) is a five-item self administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking as well as the ability to resist drinking. Scores range from a minimum of zero to a maximum of 30. Lower scores are associated with lower level of craving for alcohol. Scores are averaged over the trial.
Secondary	Carbohydrate-deficient Transferrin	End of trial, generally 16 weeks	Lab test assessing history of heavy drinking with greater specificity than GGT. Higher levels are indicative of greater levels of drinking.
Other	Self-reported Sedation on at Least One Occasion by a Participant	Every 1-2 weeks up to 16 weeks of active trial	Any reporting of feeling sedated/sleepy/drowsy

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Percentage of Heavy Drinking Days	Every 1-2 weeks up to 16 weeks of active trial	Post-randomization data were unavailable for 2 participants.	percentage of heavy drinking days	LEAST_SQUARES_MEAN
PRIMARY	Mean Percentage of Abstinent Drinking Days	Every 1-2 weeks up to 16 weeks of active trial	Post-randomization data were unavailable for 2 participants.	percentage of days	LEAST_SQUARES_MEAN
SECONDARY	Mean Spielberger State-Trait Anxiety Inventory Score [State]	Every 1-2 weeks up to 16 weeks of active trial		units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Penn Alcohol Craving Scale Score	Every 1-2 weeks up to 16 weeks of active trial		units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Carbohydrate-deficient Transferrin	End of trial, generally 16 weeks	Post-randomization CDT was not collected for all participants.	% CDT	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Self-reported Sedation on at Least One Occasion by a Participant	Every 1-2 weeks up to 16 weeks of active trial	Post-randomization data were unavailable for 2 participants.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Value	Spread	Units
Mean Percentage of Heavy Drinking Days	Placebo	39	Standard Error 4	percentage of heavy drinking days
Mean Percentage of Heavy Drinking Days	30 Mg Baclofen	42	Standard Error 4	percentage of heavy drinking days
Mean Percentage of Heavy Drinking Days	90 mg Baclofen	28	Standard Error 4	percentage of heavy drinking days
Mean Percentage of Abstinent Drinking Days	Placebo	47	Standard Error 4	percentage of days
Mean Percentage of Abstinent Drinking Days	30 Mg Baclofen	48	Standard Error 4	percentage of days
Mean Percentage of Abstinent Drinking Days	90 mg Baclofen	59	Standard Error 4	percentage of days
Mean Spielberger State-Trait Anxiety Inventory Score [State]	Placebo	35.2	Standard Error 1.16	units on a scale
Mean Spielberger State-Trait Anxiety Inventory Score [State]	30 Mg Baclofen	33.8	Standard Error 1.12	units on a scale
Mean Spielberger State-Trait Anxiety Inventory Score [State]	90 mg Baclofen	33.6	Standard Error 1.18	units on a scale
Mean Penn Alcohol Craving Scale Score	Placebo	10.1	Standard Error 0.91	units on a scale

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	40
Overall Study	STARTED	30 Mg Baclofen	43
Overall Study	STARTED	90 mg Baclofen	37
Overall Study	COMPLETED	Placebo	23
Overall Study	COMPLETED	30 Mg Baclofen	26
Overall Study	COMPLETED	90 mg Baclofen	24
Overall Study	NOT COMPLETED	Placebo	17
Overall Study	NOT COMPLETED	30 Mg Baclofen	17
Overall Study	NOT COMPLETED	90 mg Baclofen	13

Source ClinicalTrials.gov

Adverse events24

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	Sedation	Nervous system disorders	Placebo	14	40
other	Sedation	Nervous system disorders	30 Mg Baclofen	25	43
other	Sedation	Nervous system disorders	90 mg Baclofen	20	37
other	Dizziness	Nervous system disorders	Placebo	5	40
other	Dizziness	Nervous system disorders	30 Mg Baclofen	12	43
other	Dizziness	Nervous system disorders	90 mg Baclofen	8	37
other	Itchiness/rash	Skin and subcutaneous tissue disorders	Placebo	4	40
other	Itchiness/rash	Skin and subcutaneous tissue disorders	30 Mg Baclofen	8	43
other	Itchiness/rash	Skin and subcutaneous tissue disorders	90 mg Baclofen	0	37
other	Fatigue/low energy	General disorders	Placebo	2	40

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	40
Total, all-cause mortality	30 Mg Baclofen	0	43
Total, all-cause mortality	90 mg Baclofen	0	37
Total, other adverse events	Placebo	16	40
Total, other adverse events	30 Mg Baclofen	28	43
Total, other adverse events	90 mg Baclofen	21	37
Total, serious adverse events	Placebo	0	40
Total, serious adverse events	30 Mg Baclofen	0	43
Total, serious adverse events	90 mg Baclofen	1	37

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01AA020824	Efficacy and Safety of High-Dose Baclofen for Alcohol Dependence	GARBUTT, JAMES C.	UNIV OF NORTH CAROLINA CHAPEL HILL	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2013 to 2016

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT01980706

GET https://conductscience.org/api/trials/v1/NCT01980706/events?page=2

API reference For AI assistants