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Nicotine dependence may prolong the exposure to toxic substances that cause various diseases. The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning of the mesolimbic and mesocortical pathway, related to the reward system, involved on the context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows improvements in several diseases, including mood disorders such as anxiety and depression. The investigators hypothesis is that supplementation with these fatty acids can restore the levels of omega-3 and could decrease nicotine dependence. The investigators objective is to investigate a possible association between increased serum levels of omega-3 and the reduction in nicotine dependence.
Introduction: A cigarette has more than 6,000 toxic substances that can cause various diseases. Nicotine dependence may prolong the exposure to these toxic substances. The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning of the mesolimbic and mesocortical pathway, related to the reward system, involved on the context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows improvements in several diseases, including mood disorders such as anxiety and depression. The investigators hypothesis is that supplementation with these fatty acids can restore the levels of omega-3 and could decrease nicotine dependence. Objective: Investigate a possible association between increased serum levels of omega-3 and the reduction in nicotine dependence. Material and Methods: In the clinical study, placebo controlled, double-blind, parallel, randomized, will be administered to 60 volunteers: placebo or fish oil for 90 days. Psychometric assessments will be carried out, measurements of serum levels of PUFAS, levels of carbon monoxide (CO) and cotinine in plasma will be done for monitoring the clinical course. Data Analysis: Repeated measures (ANOVA) for the dependent variables (dependency, anxiety, depression, motivation, compulsion, dosage of PUFAS, exhaled CO and cotinine) and independent (groups and time) to check for significant differences. If so, a second ANOVA with covariates will be conducted. Significance is p <0.05 in all analyzes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo group will receive 3g per day of mineral oil during 90 days treatment |
|
| Omega3 | Experimental | The omega 3 group will receive 3g per day of fish oil during 90 days treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 | Drug | Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment | The Fageström Test for Nicotine Dependence is a widely used test to measure the nicotine dependence. This test was chosen to evaluate the possible changes on the nicotine dependence during the clinical trial. The range for the scale is: very low (dependence) 0-2 low (dependence) 3-4 moderate (dependence) 5 high (dependence) 6-7 very high (dependence) 8-10 So, lower levels (low scores on the scale) of the FTND measure indicates lower nicotine dependence, and higher levels (high scores on the scales) of the FTND measure indicates higher nicotine dependence. | Baseline (prior to the beginning) and after 90 days of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment | The polyunsaturated fatty acid Docosahexaenoic acid (DHA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS. | At baseline (prior to the beginning of the treatment) and after 90 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Carlos F. Galduróz, Md PhD | Universidade Federal de São Paulo (UNIFESP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade de Dependência de Drogas (UDED) | São Paulo | 55 | Brazil |
We do not plan to make individual participant data available. The data obtained was analysed and published
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No participants were excluded.
Data were collected in São Paulo/Brazil between January 2013 and August 2013. All participants signed an informed consent prior to the beginning of the study. The participants did not receive any kind of compensation for participation in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses. |
| FG001 | Omega3 | omega 3 capsules 1,000 mg fish oil taken as 3 daily doses. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days. |
| BG001 | Omega3 | omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment | The Fageström Test for Nicotine Dependence is a widely used test to measure the nicotine dependence. This test was chosen to evaluate the possible changes on the nicotine dependence during the clinical trial. The range for the scale is: very low (dependence) 0-2 low (dependence) 3-4 moderate (dependence) 5 high (dependence) 6-7 very high (dependence) 8-10 So, lower levels (low scores on the scale) of the FTND measure indicates lower nicotine dependence, and higher levels (high scores on the scales) of the FTND measure indicates higher nicotine dependence. | Posted | Mean | Standard Deviation | units on a scale | Baseline (prior to the beginning) and after 90 days of the treatment |
|
The adverse event were collected monthly (after 30, 60 and 90 days of the treatment) during the 90 days (treatment time)
No adverse event were reported by the participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Group n= 29 | placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Md PhD José Carlos F. Galduróz | Department of Psychobiology, Universidade Federal de São Paulo (UNIFESP), Rua Napoleão de Barros, São Paulo , Brazil | +55 11 2149 0000 | galduroz@unifesp.br |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D005395 | Fish Oils |
| D015525 | Fatty Acids, Omega-3 |
| D008899 | Mineral Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Drug | mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule |
|
|
| Concentration of Eicosapentaenoic Acid (EPA) | The polyunsaturated fatty acid Eicosapentaenoic acid (EPA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS. | At baseline (prior to the beginning of the treatment) and after 90 days of treatment |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Omega3 | omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA |
|
|
| Secondary | Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment | The polyunsaturated fatty acid Docosahexaenoic acid (DHA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS. | Posted | Mean | Standard Deviation | ng/ml | At baseline (prior to the beginning of the treatment) and after 90 days of treatment |
|
|
|
| Secondary | Concentration of Eicosapentaenoic Acid (EPA) | The polyunsaturated fatty acid Eicosapentaenoic acid (EPA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS. | Posted | Mean | Standard Deviation | ng/ml | At baseline (prior to the beginning of the treatment) and after 90 days of treatment |
|
|
|
| Post-Hoc | Concentration of Serum Cotinine at Baseline and After 90 Days of Treatment | Cotinine is the major metabolite of nicotine, making it its primary metabolite. Cotinine dosage is considered one of the best parameters to distinguish smokers from non-smokers as well as for the nicotine graduation consumption. The traditional cut off value used to distinguish between smokers and non-smokers is 15 ng/mL for dosages from plasma sample | Posted | Mean | Standard Deviation | ng/ml | At baseline (prior to the beginning of the treatment) and after 90 days of treatment |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Omega3 Group n= 29 | omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA | 0 | 29 | 0 | 29 | 0 | 29 |
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |
| D010577 | Petrolatum |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| Mean Difference (Final Values) |
| 30.84 |
| 1-Sided |
| 95 |
| Superiority |
| t-test, 1 sided | <0.01 | Mean Difference (Final Values) | 0.002 | 2-Sided | Superiority |
| t-test, 1 sided | <0.01 | Mean Difference (Final Values) | 4.4 | 1-Sided | Superiority |