Effects of Omegas 3 and 6 on Alcohol Dependence

NCT01211769 | Completed Phase 3 Results

• 1 other identifier: 2006/01641-6
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Dependence

Keywords

PUFAs; Alcoholism; Treatment; Effectiveness

Outcome Measures

Primary Outcomes (1)

• "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.

  3 months

Secondary Outcomes (2)

• Short Alcohol Dependence Data Questionnaire (SADD)

  3 months

• Obsessive Compulsive Drinking Scale (OCDS)

  3 months

Study Arms (4)

PUFAs

EXPERIMENTAL

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;

Drug: PUFAs

Naltrexone

ACTIVE COMPARATOR

Naltrexone chlorhydrate 50 mg

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Naltrexone + PUFAs

OTHER

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

Drug: Naltrexone + Placebo

Interventions

Naltrexone DRUG

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

Naltrexone

PUFAs 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.

PUFAs

Placebo 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).

Placebo

Naltrexone + Placebo 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.

Naltrexone + PUFAs

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Associacao Fundo de Incentivo a Psicofarmcologia: collaborator

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (1)

• 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.

  PMID: 21787433 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: José Carlos Fernandes Galduróz
• Organization: UNIFESP

galduroz@psicobio.epm.br

55 11 21490168

Study Officials

• José Carlos F Galduróz, Ph.D

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: September 29, 2010
• Study Start: February 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 29, 2010
• Results First Posted: September 29, 2010

Record last verified: 2010-09

Locations

BR (1)