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Effects of Omegas 3 and 6 on Alcohol Dependence

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Naltrexone
PUFAs
Placebo
Naltrexone + Placebo
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring PUFAs, Alcoholism, Treatment, Effectiveness

Eligibility Criteria

30 Years - 50 Years (Adult)MaleDoes not accept 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

Sites / Locations

  • Universidade Federal de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Other

Arm Label

PUFAs

Naltrexone

Placebo

Naltrexone + PUFAs

Arm 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

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.

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

Outcomes

Primary Outcome Measures

"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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 5, 2008
Last Updated
September 2, 2010
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Associacao Fundo de Incentivo a Psicofarmcologia
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1. Study Identification

Unique Protocol Identification Number
NCT01211769
Brief Title
Effects of Omegas 3 and 6 on Alcohol Dependence
Official Title
Alcohol Dependence: Study of the Possible Reduction of Compulsion by Association of Naltrexone With Poly-unsaturated Fatty Acids (PUFAs)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Associacao Fundo de Incentivo a Psicofarmcologia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
PUFAs, Alcoholism, Treatment, Effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PUFAs
Arm Type
Experimental
Arm 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;
Arm Title
Naltrexone
Arm Type
Active Comparator
Arm Description
Naltrexone chlorhydrate 50 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Naltrexone + PUFAs
Arm Type
Other
Arm 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
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil.
Intervention Type
Drug
Intervention Name(s)
PUFAs
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Name(s)
Naltrexone + Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
"Drinking Days" in the Previous Month
Description
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 Outcome Measure Information:
Title
Short Alcohol Dependence Data Questionnaire (SADD)
Description
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
Title
Obsessive Compulsive Drinking Scale (OCDS)
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Carlos F Galduróz, Ph.D
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21787433
Citation
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.
Results Reference
derived

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Effects of Omegas 3 and 6 on Alcohol Dependence

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