Trial · NCT00183196

Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone

NCT00183196, Phase 3, Completed, Medical University of South Carolina; results first posted 2013-05-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone. Trials, record NCT00183196. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00183196

On this page

Trial

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

Title: Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
NCT number: NCT00183196
Status: Completed
Phases: Phase 3
Enrollment: 150 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Alcohol Dependence
Interventions: Naltrexone, Naltrexone plus Gabapentin, Inactive Placebo
First posted: 2005-09-16
Last updated: 2018-06-07
Results first posted: 2013-05-30

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Time to Relapse to Drinking	16 weeks	Time to relapse drinking which is 5 standard drinks perday for males and 4 standard drinks per day for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol.

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	Time to Relapse to Drinking	16 weeks	Subjects who entered the analysis were all people with any drinking data post randomization. There was 2 people in naltrexone plus gabapentin, 1 person in naltrexone alone and 1 person in placebo group that had no post-randomization drinking data and were therefore not included in the intent to treat analysis presented.	days	MEAN

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Spread	Units
Time to Relapse to Drinking	Naltrexone Plus Gabapentin and CBI	69.9	Standard Error 6.5	days
Time to Relapse to Drinking	Naltrexone Plus Placebo and CBI	59.6	Standard Error 7.6	days
Time to Relapse to Drinking	Placebo Plus Placebo Plus CBI	57.3	Standard Error 6.7	days

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Naltrexone Plus Gabapentin and CBI	50
Overall Study	STARTED	Naltrexone Plus Placebo and CBI	50
Overall Study	STARTED	Placebo Plus Placebo Plus CBI	50
Overall Study	COMPLETED	Naltrexone Plus Gabapentin and CBI	30
Overall Study	COMPLETED	Naltrexone Plus Placebo and CBI	35
Overall Study	COMPLETED	Placebo Plus Placebo Plus CBI	32
Overall Study	NOT COMPLETED	Naltrexone Plus Gabapentin and CBI	20
Overall Study	NOT COMPLETED	Naltrexone Plus Placebo and CBI	15
Overall Study	NOT COMPLETED	Placebo Plus Placebo Plus CBI	18

Source ClinicalTrials.gov

Adverse events12

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	Dizziness	Nervous system disorders	Naltrexone Plus Gabapentin and CBI	20	50	33
other	Dizziness	Nervous system disorders	Naltrexone Plus Placebo and CBI	11	50	14
other	Dizziness	Nervous system disorders	Placebo Plus Placebo Plus CBI	11	50	21
other	somnolence	General disorders	Naltrexone Plus Gabapentin and CBI	39	50	106
other	somnolence	General disorders	Naltrexone Plus Placebo and CBI	29	50	81
other	somnolence	General disorders	Placebo Plus Placebo Plus CBI	31	50	90
other	Blurred vision	Eye disorders	Naltrexone Plus Gabapentin and CBI	16	50	41
other	Blurred vision	Eye disorders	Naltrexone Plus Placebo and CBI	13	50	18
other	Blurred vision	Eye disorders	Placebo Plus Placebo Plus CBI	7	50	25
other	Premature ejaculation	Renal and urinary disorders	Naltrexone Plus Gabapentin and CBI	11	39	16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Naltrexone Plus Gabapentin and CBI
Total, all-cause mortality	Naltrexone Plus Placebo and CBI
Total, all-cause mortality	Placebo Plus Placebo Plus CBI
Total, other adverse events	Naltrexone Plus Gabapentin and CBI	39	50
Total, other adverse events	Naltrexone Plus Placebo and CBI	29	50
Total, other adverse events	Placebo Plus Placebo Plus CBI	31	50
Total, serious adverse events	Naltrexone Plus Gabapentin and CBI	0	50
Total, serious adverse events	Naltrexone Plus Placebo and CBI	0	50
Total, serious adverse events	Placebo Plus Placebo Plus CBI	0	50

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21454917	RESULT

Source PubMed

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
R01AA009568	Gabapentin as an Adjunct to Naltrexone for Alcoholism	ANTON, RAYMOND F	MEDICAL UNIVERSITY OF SOUTH CAROLINA	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	1992 to 2006

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/NCT00183196

GET https://conductscience.org/api/trials/v1/NCT00183196/registered

API reference For AI assistants