Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo The placebo group will receive 3g per day of mineral oil during 90 days treatment |
Drug: Placebo
mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule
Other Names:
|
| Experimental: Omega3 The omega 3 group will receive 3g per day of fish oil during 90 days treatment |
Drug: Omega 3
Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment [Baseline (prior to the beginning) 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.
Secondary Outcome Measures
- Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment [At baseline (prior to the beginning of the treatment) 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.
- Concentration of Eicosapentaenoic Acid (EPA) [At baseline (prior to the beginning of the treatment) and after 90 days of treatment]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- healthy smokers; age between 20 and 60 years; score in Fagerström Test for Nicotine Dependence (FTND) up to 5 points (FTND > 5); high motivation to stop smoking (accessed by Richmond Test)
Exclusion Criteria:
- psychiatric disorders; taking psychoactive medications; history of alcohol and/or other drugs abuse or dependence;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Unidade de Dependência de Drogas (UDED) | São Paulo | Brazil | 55 |
Sponsors and Collaborators
- Federal University of São Paulo
Investigators
- Principal Investigator: José Carlos F. Galduróz, Md PhD, Universidade Federal de São Paulo (UNIFESP)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Tobacco&Omega
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | No participants were excluded. |
| Arm/Group Title | Placebo | Omega3 |
|---|---|---|
| Arm/Group Description | placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses. | 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 |
| Period Title: Overall Study | ||
| STARTED | 29 | 29 |
| COMPLETED | 18 | 21 |
| NOT COMPLETED | 11 | 8 |
Baseline Characteristics
| Arm/Group Title | Placebo | Omega3 | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 | Total of all reporting groups |
| Overall Participants | 29 | 29 | 58 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
47.8
(11.5)
|
46.2
(11.1)
|
47
(11.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
15
51.7%
|
13
44.8%
|
28
48.3%
|
| Male |
14
48.3%
|
16
55.2%
|
30
51.7%
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
24.3
(4.7)
|
24.7
(3.9)
|
24.5
(4.3)
|
Outcome Measures
| Title | Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment |
|---|---|
| Description | 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. |
| Time Frame | Baseline (prior to the beginning) and after 90 days of the treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Omega3 |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 29 | 29 |
| pre |
6.53
(2.01)
|
6.56
(1.52)
|
| post |
5.96
(1.85)
|
5.22
(2.15)
|
| Title | Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment |
|---|---|
| Description | 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. |
| Time Frame | At baseline (prior to the beginning of the treatment) and after 90 days of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Omega3 |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 29 | 29 |
| Pre |
747.71
(794.00)
|
645.38
(757.49)
|
| Post |
663.93
(767.41)
|
1,004.94
(1,484.63)
|
| Title | Concentration of Eicosapentaenoic Acid (EPA) |
|---|---|
| Description | 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. |
| Time Frame | At baseline (prior to the beginning of the treatment) and after 90 days of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Omega3 |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 29 | 29 |
| Pre |
77.00
(67.72)
|
86.76
(111.79)
|
| Post |
77.39
(73.22)
|
174.87
(285.37)
|
| Title | Concentration of Serum Cotinine at Baseline and After 90 Days of Treatment |
|---|---|
| Description | 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 |
| Time Frame | At baseline (prior to the beginning of the treatment) and after 90 days of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Omega3 |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 29 | 29 |
| Pre |
101.20
(65.10)
|
129.38
(85.15)
|
| Post |
97.79
(63.26)
|
98.54
(61.94)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Omega3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Test t Student | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Omega3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 30.84 | |
| Confidence Interval |
(1-Sided) 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Omega3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.002 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.4 | |
| Confidence Interval |
(1-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | The adverse event were collected monthly (after 30, 60 and 90 days of the treatment) during the 90 days (treatment time) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | No adverse event were reported by the participants | |||
| Arm/Group Title | Placebo Group n= 29 | Omega3 Group n= 29 | ||
| Arm/Group Description | 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. | 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 | ||
All Cause Mortality |
||||
| Placebo Group n= 29 | Omega3 Group n= 29 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 00/29 (0%) | 00/29 (0%) | ||
Serious Adverse Events |
||||
| Placebo Group n= 29 | Omega3 Group n= 29 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/29 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo Group n= 29 | Omega3 Group n= 29 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 00/29 (0%) | 00/29 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Md PhD José Carlos F. Galduróz |
|---|---|
| Organization | Department of Psychobiology, Universidade Federal de São Paulo (UNIFESP), Rua Napoleão de Barros, São Paulo , Brazil |
| Phone | +55 11 2149 0000 |
| galduroz@unifesp.br |
- Tobacco&Omega