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Alcohol addiction: treatment with omega-3 to prevent alcohol use

Alcohol dependence: longitudinal study about relapse prevention using polyunsaturated fatty acids (PUFAs)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-48mkgz7
Enrollment
Unknown
Registered
2021-10-05
Start date
2018-06-09
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge drinking

Interventions

Intervention Group: 59 participants in this group should ingest, orally, 1 capsule of omega-3 every 8 hours, that is, 3 capsules a day, for 3 months. The omega-3 capsules contained 1 g of fish oil, wi
0.5g protein
1.5g of total fat
0.5g of saturated fats
0.33g of monounsaturated fats
0.65g of polyunsaturated fats
376mg of eicosapentaenoic acid (EPA) and 250mg of docosahexaenoic acid (DHA). Placebo Group: 52 participants in this group should take, orally, 1 placebo capsule every 8 hours, that is, 3 capsules a d
zero carbohydrates and proteins
12g of total fat
2.5g of saturated fats
5.2mg of vitamin E
zero trans fat
dietary fiber and sodium. All participants underwent a medical screening interview to confirm that the participant met all the inclusion criteria and signed the Informed Consent Form. After this scree
Obsessive-Compulsive Drinking Scale
Penn Alcohol Craving scale
Short Alcohol Dependence Data. This entire assessment procedure took about 1 hour and a half. Participants were evaluated 1, 2 and 3 months after the start of the intervention. An attempt was also mad
D10.212.302.380.410.385

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Associação Fundo de Incentivo à Pesquisa
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Male; age between 18 and 70 years; severe alcohol use disorder according to DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders 5th. edition)

Exclusion criteria

Exclusion criteria: Volunteers with a history of allergic processes to fish; severe pathological history of hepatic, cardiovascular, renal, pulmonary, endocrine, neurological and psychiatric disorders with psychotic symptoms such as schizophrenia

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: To verify the possible reduction in the number and intensity of relapses in alcohol-dependent patients who received omega during 3 months of hospitalization, using the Timeline Followback questionnaire, pre-intervention and post-intervention.;Outcome found 1: the group that received omega consumed alcohol in fewer days, compared to the control group, in the evaluation of two months after the start of treatment and three months after the start of treatment, using the Timeline Followback questionnaire, comparing the baseline measurement (pre-intervention) with the measurement after 1, 2 and 3 months of treatment.

Secondary

MeasureTime frame
Anxiety symptoms were evaluated based on the score obtained by completing the Beck Anxiety Inventory questionnaire, comparing the pre-intervention and post-intervention scores. No statistically significant differences were found.;Symptoms of depression were evaluated based on the score obtained by completing the Beck Depression Inventory questionnaire, comparing the pre-intervention and post-intervention scores. No statistically significant differences were found.

Countries

Brazil

Contacts

Public ContactJosé Galduroz
galduroz@unifesp.br+55 11 21490155

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 12, 2026