Phase 3
N=80
Effects of Omegas 3 and 6 on Alcohol Dependence
Alcohol Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01211769 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: "Drinking Days" in the Previous Month — 19.54; 15.18; 17.75; 22.11 Days — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Naltrexone (Drug); PUFAs (Drug); Placebo (Drug); Naltrexone + Placebo (Drug)
- Age
- Adult · 30+ yrs
- Sex
- Male
- Sponsor
- Federal University of São Paulo
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY "Drinking Days" in the Previous Month |
19.54; 15.18; 17.75; 22.11; 4.72; 5.66 | <0.001 sig |
| SECONDARY Short Alcohol Dependence Data Questionnaire (SADD) |
34.90; 33.81; 31.91; 29.33; 7.81; 11.36 | <0.001 sig |
| SECONDARY Obsessive Compulsive Drinking Scale (OCDS) |
45.36; 42.45; 36.5; 37.55; 13.18; 11.81 | <0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01211769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.