Trial · NCT00262639

Prometa Protocol for Alcohol Dependence

NCT00262639, Phase 2, Phase 3, Completed, Medical University of South Carolina; results first posted 2009-08-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Prometa Protocol for Alcohol Dependence. Trials, record NCT00262639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00262639

On this page

Trial

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

Title: Prometa Protocol for Alcohol Dependence
NCT number: NCT00262639
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 60 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Alcohol Dependence
Interventions: Flumazenil and Gabapentin, Placebo
First posted: 2005-12-07
Last updated: 2019-02-15
Results first posted: 2009-08-14

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Percent Subjects Completely Abstinent	6 week trial	percent of subjects completely abstinent during the six week medication study study
Primary	Percent Days Abstinent	Weeks 1 to 6	percent days abstinent during treatment

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 Subjects Completely Abstinent	6 week trial		percent of participants	NUMBER
PRIMARY	Percent Days Abstinent	Weeks 1 to 6		percent days	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Percent Subjects Completely Abstinent	Low CIWA Flumazenil/Gabapentin	44		percent of participants
Percent Subjects Completely Abstinent	Low CIWAar Placebo	19		percent of participants
Percent Subjects Completely Abstinent	High CIWAar Placebo	33		percent of participants
Percent Subjects Completely Abstinent	High CIWAar Flumazenil/Gabapentin	71		percent of participants
Percent Days Abstinent	Low CIWA Flumazenil/Gabapentin	70.8	Standard Deviation 24.2	percent days
Percent Days Abstinent	Low CIWAar Placebo	86.1	Standard Deviation 20.7	percent days
Percent Days Abstinent	High CIWAar Placebo	75.9	Standard Deviation 27	percent days
Percent Days Abstinent	High CIWAar Flumazenil/Gabapentin	95.9	Standard Deviation 9.7	percent days

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Low CIWA Flumazenil/Gabapentin	18
Overall Study	STARTED	Low CIWAar Placebo	26
Overall Study	STARTED	High CIWAar Placebo	9
Overall Study	STARTED	High CIWAar Flumazenil/Gabapentin	7
Overall Study	COMPLETED	Low CIWA Flumazenil/Gabapentin	18
Overall Study	COMPLETED	Low CIWAar Placebo	26
Overall Study	COMPLETED	High CIWAar Placebo	9
Overall Study	COMPLETED	High CIWAar Flumazenil/Gabapentin	7
Overall Study	NOT COMPLETED	Low CIWA Flumazenil/Gabapentin	0
Overall Study	NOT COMPLETED	Low CIWAar Placebo	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Low CIWA Flumazenil/Gabapentin
Total, all-cause mortality	Low CIWAar Placebo
Total, all-cause mortality	High CIWAar Placebo
Total, all-cause mortality	High CIWAar Flumazenil/Gabapentin
Total, other adverse events	Low CIWA Flumazenil/Gabapentin	0	18
Total, other adverse events	Low CIWAar Placebo	0	26
Total, other adverse events	High CIWAar Placebo	0	9
Total, other adverse events	High CIWAar Flumazenil/Gabapentin	0	7
Total, serious adverse events	Low CIWA Flumazenil/Gabapentin	0	18
Total, serious adverse events	Low CIWAar Placebo	0	26

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19593171	RESULT	PubMed
21631542	RESULT	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 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/NCT00262639

GET https://conductscience.org/api/trials/v1/NCT00262639/registered

API reference For AI assistants