Trial · NCT01211769

Effects of Omegas 3 and 6 on Alcohol Dependence

NCT01211769, Phase 3, Completed, Federal University of São Paulo; results first posted 2010-09-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Omegas 3 and 6 on Alcohol Dependence. Trials, record NCT01211769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01211769

On this page

Trial

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

Title: Effects of Omegas 3 and 6 on Alcohol Dependence
NCT number: NCT01211769
Status: Completed
Phases: Phase 3
Enrollment: 80 participants, actual
Lead sponsor: Federal University of São Paulo
Conditions: Alcohol Dependence
Interventions: Naltrexone, PUFAs, Placebo, Naltrexone + Placebo
First posted: 2010-09-29
Last updated: 2010-09-29
Results first posted: 2010-09-29

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	"Drinking Days" in the Previous Month	3 months	The Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
Secondary	Short Alcohol Dependence Data Questionnaire (SADD)	3 months	The Short Alcohol Dependence Data is a self-completion questionnaire designed to evaluate the presence and the degree of severity of alcohol dependence and consists of 15 questions. The minimum and maximum scores possible are 0 and 45 points respectively. The range of 1-9 is considered as low dependence, 10-19 medium dependence and 20 or more high dependence.
Secondary	Obsessive Compulsive Drinking Scale (OCDS)	3 months	The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 - 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Drinking Days in the Previous Month	3 months	Days	MEAN
SECONDARY	Short Alcohol Dependence Data Questionnaire (SADD)	3 months	Units on a Scale	MEAN
SECONDARY	Obsessive Compulsive Drinking Scale (OCDS)	3 months	Units on a Scale	MEAN

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Category	Value	Spread	Units
Drinking Days in the Previous Month	Placebo	Number of Drinking Days Baseline	19.54	Standard Deviation 9.85	Days
Drinking Days in the Previous Month	Naltrexone	Number of Drinking Days Baseline	15.18	Standard Deviation 10.32	Days
Drinking Days in the Previous Month	PUFAs	Number of Drinking Days Baseline	17.75	Standard Deviation 9.80	Days
Drinking Days in the Previous Month	Naltrexone + PUFAs	Number of Drinking Days Baseline	22.11	Standard Deviation 11.63	Days
Drinking Days in the Previous Month	Placebo	Number of Drinking Days Final	4.72	Standard Deviation 8.74	Days
Drinking Days in the Previous Month	Naltrexone	Number of Drinking Days Final	5.66	Standard Deviation 7.48	Days
Drinking Days in the Previous Month	PUFAs	Number of Drinking Days Final	11.08	Standard Deviation 12.87	Days
Drinking Days in the Previous Month	Naltrexone + PUFAs	Number of Drinking Days Final	11.12	Standard Deviation 13.74	Days
Short Alcohol Dependence Data Questionnaire (SADD)	Placebo	SADD Baseline	34.90	Standard Deviation 8.93	Units on a Scale
Short Alcohol Dependence Data Questionnaire (SADD)	Naltrexone	SADD Baseline	33.81	Standard Deviation 9.92	Units on a Scale

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow16

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	20
Overall Study	STARTED	Naltrexone	20
Overall Study	STARTED	PUFAs	20
Overall Study	STARTED	Naltrexone + PUFAs	20
Overall Study	Participants/Group	Placebo	20
Overall Study	Participants/Group	Naltrexone	20
Overall Study	Participants/Group	PUFAs	20
Overall Study	Participants/Group	Naltrexone + PUFAs	20
Overall Study	COMPLETED	Placebo	11
Overall Study	COMPLETED	Naltrexone	10

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events4

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	Flatulence	Gastrointestinal disorders	Placebo	0	20	0
other	Flatulence	Gastrointestinal disorders	Naltrexone	1	20	3
other	Flatulence	Gastrointestinal disorders	PUFAs	1	20	4
other	Flatulence	Gastrointestinal disorders	Naltrexone + PUFAs	1	20	1

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Naltrexone
Total, all-cause mortality	PUFAs
Total, all-cause mortality	Naltrexone + PUFAs
Total, other adverse events	Placebo	0	20
Total, other adverse events	Naltrexone	1	20
Total, other adverse events	PUFAs	1	20
Total, other adverse events	Naltrexone + PUFAs	1	20
Total, serious adverse events	Placebo	0	20
Total, serious adverse events	Naltrexone	0	20

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21787433	DERIVED

Source 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/NCT01211769

GET https://conductscience.org/api/trials/v1/NCT01211769/results?page=2

API reference For AI assistants