Trial · NCT00391716

Gabapentin Treatment of Alcohol Dependence

NCT00391716, Phase 2, Completed, The Scripps Research Institute; results first posted 2014-11-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Gabapentin Treatment of Alcohol Dependence. Trials, record NCT00391716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00391716

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Trial

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

Title: Gabapentin Treatment of Alcohol Dependence
NCT number: NCT00391716
Status: Completed
Phases: Phase 2
Enrollment: 150 participants, actual
Lead sponsor: The Scripps Research Institute
Conditions: Alcoholism, Alcohol Dependence
Interventions: Gabapentin 900mg, behavioral counseling, placebo, gabapentin 1800mg
First posted: 2006-10-24
Last updated: 2014-11-10
Results first posted: 2014-11-10

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Drinking	12-week	Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).
Secondary	Mood	12-week	Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups.
Secondary	Sleep	12-week	The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups.
Secondary	Craving	12-week	Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Drinking	12-week	All randomized subjects included in denominator for rate determination.	participants	NUMBER
SECONDARY	Mood	12-week		units on a scale	MEAN
SECONDARY	Sleep	12-week		units on a scale	MEAN
SECONDARY	Craving	12-week		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Drinking	Gabapentin 900mg Daily	6		participants
Drinking	Gabapentin 1800mg Daily	8		participants
Drinking	Placebo Daily	2		participants
Mood	Gabapentin 900mg Daily	5.08	Standard Error .53	units on a scale
Mood	Gabapentin 1800mg Daily	3.62	Standard Error .44	units on a scale
Mood	Placebo Daily	5.40	Standard Error .39	units on a scale
Sleep	Gabapentin 900mg Daily	4.04	Standard Error .2	units on a scale
Sleep	Gabapentin 1800mg Daily	3.24	Standard Error .17	units on a scale
Sleep	Placebo Daily	4.50	Standard Error .22	units on a scale
Craving	Gabapentin 900mg Daily	33.66	Standard Error .78	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Gabapentin 900mg Daily	54
Overall Study	STARTED	Gabapentin 1800mg Daily	47
Overall Study	STARTED	Placebo Daily	49
Overall Study	COMPLETED	Gabapentin 900mg Daily	27
Overall Study	COMPLETED	Gabapentin 1800mg Daily	28
Overall Study	COMPLETED	Placebo Daily	30
Overall Study	NOT COMPLETED	Gabapentin 900mg Daily	27
Overall Study	NOT COMPLETED	Gabapentin 1800mg Daily	19
Overall Study	NOT COMPLETED	Placebo Daily	19

Source ClinicalTrials.gov

Adverse events42

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	Fatigue	Nervous system disorders	Gabapentin 900mg Daily	13	54
other	Fatigue	Nervous system disorders	Gabapentin 1800mg Daily	9	47
other	Fatigue	Nervous system disorders	Placebo Daily	12	49
other	Headache	Nervous system disorders	Gabapentin 900mg Daily	7	54
other	Headache	Nervous system disorders	Gabapentin 1800mg Daily	6	47
other	Headache	Nervous system disorders	Placebo Daily	8	49
other	Insomnia	Nervous system disorders	Gabapentin 900mg Daily	10	54
other	Insomnia	Nervous system disorders	Gabapentin 1800mg Daily	6	47
other	Insomnia	Nervous system disorders	Placebo Daily	11	49
other	Anxiety	Psychiatric disorders	Gabapentin 900mg Daily	2	54

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gabapentin 900mg Daily
Total, all-cause mortality	Gabapentin 1800mg Daily
Total, all-cause mortality	Placebo Daily
Total, other adverse events	Gabapentin 900mg Daily	13	54
Total, other adverse events	Gabapentin 1800mg Daily	9	47
Total, other adverse events	Placebo Daily	12	49
Total, serious adverse events	Gabapentin 900mg Daily	2	54
Total, serious adverse events	Gabapentin 1800mg Daily	0	47
Total, serious adverse events	Placebo Daily	0	49

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24190578	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
R37AA014028	Duloxetine versus Pregabalin for Treatment of Alcohol Dependence	MASON, BARBARA J	SCRIPPS RESEARCH INSTITUTE, THE	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2003 to 2012

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/NCT00391716

GET https://conductscience.org/api/trials/v1/NCT00391716/events?page=2

API reference For AI assistants