Trial · NCT00498628

Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency

NCT00498628, Phase 2, Completed, National Institute on Alcohol Abuse and Alcoholism (NIAAA); results first posted 2012-05-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency. Trials, record NCT00498628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00498628

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Trial

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

Title: Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency
NCT number: NCT00498628
Status: Completed
Phases: Phase 2
Enrollment: 224 participants, actual
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions: Alcoholism, Alcohol Abuse
Interventions: Quetiapine fumarate, Placebo
First posted: 2007-07-10
Last updated: 2019-03-19
Results first posted: 2012-05-30

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Percent Heavy Drinking Days	Weeks 3 - 11	A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.
Secondary	Percent Days Abstinent	Weeks 3-11	Timeline Follow-back drinking data is used to calculate the % of days abstinent per week during Weeks 3-11
Secondary	Drinks Per Drinking Day	Study Weeks 3-11	Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per drinking day
Secondary	Drinks Per Day	Study Weeks 3-11	Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per day
Secondary	Percent Very Heavy Drinking Day	Study Weeks 3-11	Timeline Follow Back data used to calculate the % of very heavy drinking days per week. Heavy drinking is 10+ drinks per day for females and 12+ drinks per day for males
Secondary	Percent Subjects Abstinent	Study Weeks 3-11	Timeline Follow Back data used to calculate the % of subjects that maintained abstinence weeks 3-11.
Secondary	Percent Subjects With no Heavy Drinking Day	Study Weeks 3-11	Timeline Follow Back data used to calculate the % of subjects that didn't have a heavy drinking day during study weeks 3-11.
Secondary	Drinking Consequences Score	Weeks 6 & 12	Drinkers Inventory of Consequences (DrInC) - Alcohol-related problems are determined using the DrInC (Miller et al., 1995). The DrInC is a self-administered 50-item questionnaire designed to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Each scale provides a lifetime and past 3-month measure of adverse consequences, and scales can be combined to assess total adverse consequences. We used a modified version of the DrInC that just included the 45-items that summed the Interpersonal, Physical, Social, and Impulsivity items. This total score (min=0, max=135) was analyzed in this study with high scores indicative of more alcohol-related consequences (a poor outcome for a given study participant). The DrInC was assessed at study weeks 6 and 12. Analyses averaged across these weeks.
Secondary	Penn Alcohol Craving Score (PACS_	Weeks 4, 6, 8, 10, and 12	The Penn Alcohol Craving Scale (PACS) is a five-item, self-report measure that includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week (Flannery et al., 1999). The summed total score of the 5 items was used in the analysis (min=0, max=30) with higher scores indicative of higher craving for alcohol (a poor outcome). Based on clinical study results, the PACS has been shown to be a reliable and valid measure of alcohol craving and can predict subjects at risk for subsequent relapse. The PACS was assessed at study weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks.
Secondary	Montgomery-Asberg Depression Rating Scale (MADRS)	Weeks 3-11	The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression (Montgomery and Asberg, 1979). The scale was constructed to be sensitive to changes in treatment effects. Its capacity to differentiate between responders and non-responders to antidepressant treatment has been shown to be comparable to the Hamilton Rating Scale for Depression, another established measure of depressive symptomatology, but the MADRS has greater sensitivity to change during the course of a depressive phase. It has exhibited high inter-rater reliability and appears to be oriented more towards psychic as opposed to somatic aspects of depression. The MADRS is the sum of the 10-item in a checklist where items are rated on a scale of 0 to 6 with anchors at 2-point intervals. Scores range from 0 to 60. Higher scores are indicative of greater depressive symptoms (a poor outcome). The MADRS was assessed at weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Heavy Drinking Days	Weeks 3 - 11	Intention to Treat	percentage of heavy drinking days	LEAST_SQUARES_MEAN
SECONDARY	Percent Days Abstinent	Weeks 3-11		percentage of days abstinent	LEAST_SQUARES_MEAN
SECONDARY	Drinks Per Drinking Day	Study Weeks 3-11		drinks per drinking day	LEAST_SQUARES_MEAN
SECONDARY	Drinks Per Day	Study Weeks 3-11		drinks per day	LEAST_SQUARES_MEAN
SECONDARY	Percent Very Heavy Drinking Day	Study Weeks 3-11		percentage heavy drinking days	LEAST_SQUARES_MEAN
SECONDARY	Percent Subjects Abstinent	Study Weeks 3-11		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percent Subjects With no Heavy Drinking Day	Study Weeks 3-11		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Drinking Consequences Score	Weeks 6 & 12		score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Penn Alcohol Craving Score (PACS_	Weeks 4, 6, 8, 10, and 12		score on a scale	MEAN
SECONDARY	Montgomery-Asberg Depression Rating Scale (MADRS)	Weeks 3-11		score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group28

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

Outcome	Group	Value	Spread	Units
Percent Heavy Drinking Days	Quetiapine Fumerate Plus Medical Management	37.1	Standard Error 3.5	percentage of heavy drinking days
Percent Heavy Drinking Days	Sugar Pill Plus Medical Management	37.9	Standard Error 3.34	percentage of heavy drinking days
Percent Days Abstinent	Quetiapine Fumerate Plus Medical Management	49.5	Standard Error 3.71	percentage of days abstinent
Percent Days Abstinent	Sugar Pill Plus Medical Management	47.1	Standard Error 3.54	percentage of days abstinent
Drinks Per Drinking Day	Quetiapine Fumerate Plus Medical Management	6.2	Standard Error .47	drinks per drinking day
Drinks Per Drinking Day	Sugar Pill Plus Medical Management	6.3	Standard Error .45	drinks per drinking day
Drinks Per Day	Quetiapine Fumerate Plus Medical Management	4.3	Standard Error 0.43	drinks per day
Drinks Per Day	Sugar Pill Plus Medical Management	4.4	Standard Error 0.41	drinks per day
Percent Very Heavy Drinking Day	Quetiapine Fumerate Plus Medical Management	16.5	Standard Error 2.56	percentage heavy drinking days
Percent Very Heavy Drinking Day	Sugar Pill Plus Medical Management	18.8	Standard Error 2.44	percentage heavy drinking days

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Quetiapine Fumerate Plus Medical Management	105
Overall Study	STARTED	Sugar Pill Plus Medical Management	113
Overall Study	COMPLETED	Quetiapine Fumerate Plus Medical Management	90
Overall Study	COMPLETED	Sugar Pill Plus Medical Management	92
Overall Study	NOT COMPLETED	Quetiapine Fumerate Plus Medical Management	15
Overall Study	NOT COMPLETED	Sugar Pill Plus Medical Management	21

Source ClinicalTrials.gov

Adverse events74

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	Quetiapine Fumerate Plus Medical Management	15	105	20
other	Dizziness	Nervous system disorders	Sugar Pill Plus Medical Management	5	113	6
other	Dry Mouth	Gastrointestinal disorders	Quetiapine Fumerate Plus Medical Management	34	105	36
other	Dry Mouth	Gastrointestinal disorders	Sugar Pill Plus Medical Management	10	113	11
other	Dyspepsia	Gastrointestinal disorders	Quetiapine Fumerate Plus Medical Management	14	105	22
other	Dyspepsia	Gastrointestinal disorders	Sugar Pill Plus Medical Management	2	113	2
other	Increased Appetite	Metabolism and nutrition disorders	Quetiapine Fumerate Plus Medical Management	12	105	12
other	Increased Appetite	Metabolism and nutrition disorders	Sugar Pill Plus Medical Management	1	113	1
other	Sedation	Nervous system disorders	Quetiapine Fumerate Plus Medical Management	16	105	18
other	Sedation	Nervous system disorders	Sugar Pill Plus Medical Management	3	113	3

1 to 10 of 74Source ClinicalTrials.gov

See all 74 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Quetiapine Fumerate Plus Medical Management
Total, all-cause mortality	Sugar Pill Plus Medical Management
Total, other adverse events	Quetiapine Fumerate Plus Medical Management	105	105
Total, other adverse events	Sugar Pill Plus Medical Management	110	113
Total, serious adverse events	Quetiapine Fumerate Plus Medical Management	6	105
Total, serious adverse events	Sugar Pill Plus Medical Management	5	113

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21950727	RESULT	PubMed
32963470	DERIVED	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 comparisons3

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

Comparison	Source
Quetiapine Fumerate Plus Medical Management vs Sugar Pill Plus Medical Management: Percent Subjects With no Heavy Drinking Day	Trial comparisons
Quetiapine Fumerate Plus Medical Management vs Sugar Pill Plus Medical Management: Percent Subjects Abstinent	Trial comparisons
Quetiapine Fumerate Plus Medical Management vs Sugar Pill Plus Medical Management: 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.

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