Trial · NCT00929344

Duloxetine Versus Pregabalin for Alcohol Dependence

NCT00929344, Phase 2, Completed, The Scripps Research Institute; results first posted 2017-03-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Duloxetine Versus Pregabalin for Alcohol Dependence. Trials, record NCT00929344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00929344

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Trial

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

Title: Duloxetine Versus Pregabalin for Alcohol Dependence
NCT number: NCT00929344
Status: Completed
Phases: Phase 2
Enrollment: 150 participants, actual
Lead sponsor: The Scripps Research Institute
Conditions: Alcohol Dependence
Interventions: Pregabalin, Duloxetine, Standardized behavioral therapy, Standardized behavioral therapy, Placebo, Standardized behavioral therapy
First posted: 2009-06-29
Last updated: 2017-05-04
Results first posted: 2017-03-28

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Baseline and Week 12	Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
Primary	Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12	Baseline and Week 12	Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
Primary	Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12	Baseline and Week 12	Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Baseline and Week 12	drinks/week	MEAN
PRIMARY	Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12	Baseline and Week 12	drinking days/week	MEAN
PRIMARY	Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12	Baseline and Week 12	drinks/drinking day	MEAN

Source ClinicalTrials.gov

Results by group27

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Duloxetine	Drinks/week Baseline	42.07	Standard Deviation 17.94	drinks/week
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Pregabalin	Drinks/week Baseline	56.67	Standard Deviation 50.93	drinks/week
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Placebo	Drinks/week Baseline	41.20	Standard Deviation 27.39	drinks/week
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Duloxetine	Drinks/week Week 12	9.16	Standard Deviation 11.90	drinks/week
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Pregabalin	Drinks/week Week 12	7.59	Standard Deviation 15.73	drinks/week
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Placebo	Drinks/week Week 12	8.06	Standard Deviation 11.22	drinks/week
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Duloxetine	Drinks/week Change	-32.91	Standard Deviation 20.38	drinks/week
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Pregabalin	Drinks/week Change	-49.08	Standard Deviation 44.91	drinks/week
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12	Placebo	Drinks/week Change	-33.15	Standard Deviation 23.32	drinks/week
Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12	Duloxetine	Drinking Days/Week Baseline	5.11	Standard Deviation 1.29	drinking days/week

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Duloxetine	50
Overall Study	STARTED	Pregabalin	50
Overall Study	STARTED	Placebo	50
Overall Study	COMPLETED	Duloxetine	28
Overall Study	COMPLETED	Pregabalin	37
Overall Study	COMPLETED	Placebo	29
Overall Study	NOT COMPLETED	Duloxetine	22
Overall Study	NOT COMPLETED	Pregabalin	13
Overall Study	NOT COMPLETED	Placebo	21

Source ClinicalTrials.gov

Adverse events111

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	Vision blurred	Eye disorders	Duloxetine	0	50
other	Vision blurred	Eye disorders	Pregabalin	4	50
other	Vision blurred	Eye disorders	Placebo	1	50
other	Constipation	Gastrointestinal disorders	Duloxetine	6	50
other	Constipation	Gastrointestinal disorders	Pregabalin	7	50
other	Constipation	Gastrointestinal disorders	Placebo	3	50
other	Diarrhoea	Gastrointestinal disorders	Duloxetine	9	50
other	Diarrhoea	Gastrointestinal disorders	Pregabalin	0	50
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	50
other	Dry mouth	Gastrointestinal disorders	Duloxetine	7	50

1 to 10 of 111Source ClinicalTrials.gov

See all 111 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Duloxetine
Total, all-cause mortality	Pregabalin
Total, all-cause mortality	Placebo
Total, other adverse events	Duloxetine	43	50
Total, other adverse events	Pregabalin	35	50
Total, other adverse events	Placebo	33	50
Total, serious adverse events	Duloxetine	2	50
Total, serious adverse events	Pregabalin	0	50
Total, serious adverse events	Placebo	4	50

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
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

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