Trial · NCT01141049

Gabapentin for Abstinence Initiation in Alcohol Dependence

NCT01141049, Phase 2, Phase 3, Completed, New York State Psychiatric Institute; results first posted 2018-07-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Gabapentin for Abstinence Initiation in Alcohol Dependence. Trials, record NCT01141049. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01141049

On this page

Trial

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

Title: Gabapentin for Abstinence Initiation in Alcohol Dependence
NCT number: NCT01141049
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 40 participants, actual
Lead sponsor: New York State Psychiatric Institute
Conditions: Alcohol Dependence
Interventions: Gabapentin, Placebo
First posted: 2010-06-10
Last updated: 2019-04-24
Results first posted: 2018-07-18

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Percent of Heavy Drinking Days Per Week	assesed over 8 weeks, presented for week 8 of trial	percent of heavy drinking days as defined as 5 drinks per day for males and 4 drinks per day for females over the course of a study week.
Secondary	Percent Days of Abstinence From Alcohol	assessed for up to 8 weeks, presented at week 8 of trial	During the course of 8 weeks the medication aims to determine whether it is effective in reducing alcohol consumption, and promoting abstinence in alcohol-dependent patients.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent of Heavy Drinking Days Per Week	assesed over 8 weeks, presented for week 8 of trial		percent of heavy drinking days	MEAN
SECONDARY	Percent Days of Abstinence From Alcohol	assessed for up to 8 weeks, presented at week 8 of trial		percent of days abstinent	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Percent of Heavy Drinking Days Per Week	Gabapentin	22.5	Standard Deviation 34.0	percent of heavy drinking days
Percent of Heavy Drinking Days Per Week	Placebo	53.9	Standard Deviation 44.0	percent of heavy drinking days
Percent Days of Abstinence From Alcohol	Gabapentin	50	Standard Deviation 37	percent of days abstinent
Percent Days of Abstinence From Alcohol	Placebo	27.5	Standard Deviation 38	percent of days abstinent

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Gabapentin	19
Overall Study	STARTED	Placebo	21
Overall Study	COMPLETED	Gabapentin	14
Overall Study	COMPLETED	Placebo	13
Overall Study	NOT COMPLETED	Gabapentin	5
Overall Study	NOT COMPLETED	Placebo	8

Source ClinicalTrials.gov

Adverse events34

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	Gabapentin	1	19	1
other	abdominal pain	Gastrointestinal disorders	Placebo	1	21	1
other	anxiety	General disorders	Gabapentin	0	19	0
other	anxiety	General disorders	Placebo	1	21	1
other	appetite change	Gastrointestinal disorders	Gabapentin	1	19	1
other	appetite change	Gastrointestinal disorders	Placebo	0	21	0
other	cough	Respiratory, thoracic and mediastinal disorders	Gabapentin	0	19	0
other	cough	Respiratory, thoracic and mediastinal disorders	Placebo	1	21	1
other	diarrhea	Gastrointestinal disorders	Gabapentin	1	19	1
other	diarrhea	Gastrointestinal disorders	Placebo	0	21	0

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gabapentin	0	19
Total, all-cause mortality	Placebo	0	21
Total, other adverse events	Gabapentin	15	19
Total, other adverse events	Placebo	11	21
Total, serious adverse events	Gabapentin	0	19
Total, serious adverse events	Placebo	0	21

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34120336	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 comparisons2

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

Comparison	Source
Gabapentin vs Placebo: deaths from any cause	Trial comparisons
Gabapentin vs Placebo: serious adverse events	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/NCT01141049

GET https://conductscience.org/api/trials/v1/NCT01141049/events?page=2

API reference For AI assistants