Effects of Omegas 3 and 6 on Alcohol Dependence

Federal University of São Paulo

Status and phase: Completed; Phase 3

Conditions: Alcohol Dependence

Treatments: Drug: PUFAs; Drug: Naltrexone + Placebo; Drug: Naltrexone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01211769

2006/01641-6

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Male

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

PUFAs

Experimental group

Description:

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;

Treatment:

Drug: PUFAs

Naltrexone

Active Comparator group

Description:

Naltrexone chlorhydrate 50 mg

Treatment:

Drug: Naltrexone

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Naltrexone + PUFAs

Other group

Description:

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

Treatment:

Drug: Naltrexone + Placebo