Trial Outcomes & Findings for Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence (NCT NCT01735279)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

58 participants

Primary outcome timeframe

Baseline (prior to the beginning) and after 90 days of the treatment

Results posted on

2020-10-14

Participant Flow

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.

No participants were excluded.

Participant milestones

Participant milestones
Measure	Placebo placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses.	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
Overall Study STARTED	29	29
Overall Study COMPLETED	18	21
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses.	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
Overall Study Lost to Follow-up	11	8

Baseline Characteristics

Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=29 Participants 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.	Omega3 n=29 Participants 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 n=58 Participants Total of all reporting groups
Age, Continuous	47.8 years STANDARD_DEVIATION 11.5 • n=93 Participants	46.2 years STANDARD_DEVIATION 11.1 • n=4 Participants	47 years STANDARD_DEVIATION 11.3 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	13 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	16 Participants n=4 Participants	30 Participants n=27 Participants
Body Mass Index (BMI)	24.3 kg/m^2 STANDARD_DEVIATION 4.7 • n=93 Participants	24.7 kg/m^2 STANDARD_DEVIATION 3.9 • n=4 Participants	24.5 kg/m^2 STANDARD_DEVIATION 4.3 • n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants 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.	Omega3 n=29 Participants 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
Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment pre	6.53 units on a scale Standard Deviation 2.01	6.56 units on a scale Standard Deviation 1.52
Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment post	5.96 units on a scale Standard Deviation 1.85	5.22 units on a scale Standard Deviation 2.15

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants 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.	Omega3 n=29 Participants 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
Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment Pre	747.71 ng/ml Standard Deviation 794.00	645.38 ng/ml Standard Deviation 757.49
Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment Post	663.93 ng/ml Standard Deviation 767.41	1,004.94 ng/ml Standard Deviation 1,484.63

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants 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.	Omega3 n=29 Participants 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
Concentration of Eicosapentaenoic Acid (EPA) Pre	77.00 ng/ml Standard Deviation 67.72	86.76 ng/ml Standard Deviation 111.79
Concentration of Eicosapentaenoic Acid (EPA) Post	77.39 ng/ml Standard Deviation 73.22	174.87 ng/ml Standard Deviation 285.37

POST_HOC outcome

Timeframe: At baseline (prior to the beginning of the treatment) 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

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants 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.	Omega3 n=29 Participants 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
Concentration of Serum Cotinine at Baseline and After 90 Days of Treatment Pre	101.20 ng/ml Standard Deviation 65.10	129.38 ng/ml Standard Deviation 85.15
Concentration of Serum Cotinine at Baseline and After 90 Days of Treatment Post	97.79 ng/ml Standard Deviation 63.26	98.54 ng/ml Standard Deviation 61.94

Adverse Events

Placebo Group n= 29

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omega3 Group n= 29

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Md PhD José Carlos F. Galduróz

Department of Psychobiology, Universidade Federal de São Paulo (UNIFESP), Rua Napoleão de Barros, São Paulo , Brazil

Phone: +55 11 2149 0000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place