Effects of Omegas 3 and 6 on Alcohol Dependence

Federal University of São Paulo80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alcohol Dependence

Interventions

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

PUFAsDRUG

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.

PlaceboDRUG

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 + PlaceboDRUG

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.

Eligibility

Sex: MALEMin age: 30 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

"Drinking Days" in the Previous Month

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.

Time frame: 3 months

Secondary Outcomes

Short Alcohol Dependence Data Questionnaire (SADD)

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.

Time frame: 3 months

Obsessive Compulsive Drinking Scale (OCDS)

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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