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Effects of Omegas 3 and 6 on Alcohol Dependence

NCT ID: NCT01211769

Last Updated: 2010-09-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-06-30

Brief Summary

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Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some studies have shown that alcohol alters the environment of the membranes, mainly by modifying their permeability through the lipid fraction. These lipids are known as essential fatty acids (EFA) because they are obtained only through the diet, as the human body is unable to synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3, are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery.

Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol dependent patients.

Detailed Description

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Conditions

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Alcohol Dependence

Keywords

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PUFAs Alcoholism Treatment Effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PUFAs

Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;

Group Type EXPERIMENTAL

PUFAs

Intervention Type DRUG

Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs; associated to a pill with 50mg of talcum powder, identical to the pill of naltrexone.

Naltrexone

Naltrexone chlorhydrate 50 mg

Group Type ACTIVE_COMPARATOR

Naltrexone

Intervention Type DRUG

A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil.

Placebo

Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;

Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A pill with 50mg of talcum powder, identical to the pill of naltrexone; associated to PUFAs Placebo pills (yellow liquid paraffin identical to the pills of borage seed and fish oil).

Naltrexone + PUFAs

Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;

Naltrexone chlorhydrate 50 mg

Group Type OTHER

Naltrexone + Placebo

Intervention Type DRUG

A pill of naltrexone chlorhydrate 50mg, associated to Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs.

Interventions

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Naltrexone

A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil.

Intervention Type DRUG

PUFAs

Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs; associated to a pill with 50mg of talcum powder, identical to the pill of naltrexone.

Intervention Type DRUG

Placebo

A pill with 50mg of talcum powder, identical to the pill of naltrexone; associated to PUFAs Placebo pills (yellow liquid paraffin identical to the pills of borage seed and fish oil).

Intervention Type DRUG

Naltrexone + Placebo

A pill of naltrexone chlorhydrate 50mg, associated to Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* severe alcohol dependence
* no history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies, as well as no history of psychiatric disorders, dependences other than alcohol and/or tobacco, and blood test results outside the reference range

Exclusion Criteria

* history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies
* dependences other than alcohol and/or tobacco
* psychiatric disorders
* test laboratories results outside the reference range
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Associacao Fundo de Incentivo a Psicofarmcologia

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Adjuncto Professor of UNIFESP

Principal Investigators

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José Carlos F Galduróz, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Fogaca MN, Santos-Galduroz RF, Eserian JK, Galduroz JC. The effects of polyunsaturated fatty acids in alcohol dependence treatment--a double-blind, placebo-controlled pilot study. BMC Clin Pharmacol. 2011 Jul 26;11:10. doi: 10.1186/1472-6904-11-10.

Reference Type DERIVED
PMID: 21787433 (View on PubMed)

Other Identifiers

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2006/01641-6

Identifier Type: -

Identifier Source: org_study_id