Tobacco DependencePhase 3NCT01735279

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

A Phase 3 study testing Omega 3 in people with Tobacco Dependence and Nicotine Dependence, run by Federal University of São Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Tobacco Dependence, Nicotine Dependence
What is being tested?: Omega 3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 58 participants
Where: 1 siteBrazil
Study dates: Jan 2013to Mar 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

psychiatric disorders; taking psychoactive medications; history of alcohol and/or other drugs abuse or dependence;

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Unidade de Dependência de Drogas (UDED)
São Paulo, 55

Other trials in Brazil

About this study

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

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.

Read the 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.

Conditions: Tobacco Dependence, Nicotine Dependence
Being tested: Omega 3, Placebo
Keywords: tobacco dependence, tobacco treatment, omega 3 series, polyunsaturated fatty acids
Medical subject headings: Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omega 3Drug
Also called fish oil, omega 3 fatty acid
Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.
PlaceboDrug
Also called mineral oil
mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule

Study groups in NCT01735279
Study group	Role	What they receive
Placebo	Placebo comparator	The placebo group will receive 3g per day of mineral oil during 90 days treatment Receives: Drug: Placebo
Omega3	Experimental	The omega 3 group will receive 3g per day of fish oil during 90 days treatment Receives: Drug: Omega 3

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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.
Measured: At baseline (prior to the beginning of the treatment) and after 90 days of treatment
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.
Measured: At baseline (prior to the beginning of the treatment) and after 90 days of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Mar 2014

First posted28 Nov 2012 (estimated)
Study startJan 2013
Primary completionDec 2013
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tobacco DependenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01735279
Sponsor's protocol ID: Tobacco&Omega
Status last verified: Sep 2020
First submitted: 23 Nov 2012
Last updated: 14 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: We do not plan to make individual participant data available. The data obtained was analysed and published

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tobacco Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence"
ClinicalTrials.gov ID: NCT01735279
Acronym / sponsor ID: Tobacco&Omega
Conditions: Tobacco Dependence, Nicotine Dependence
Keywords: tobacco dependence, tobacco treatment, omega 3 series, polyunsaturated fatty acids
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Federal University of São PauloUniversity, hospital or other
Study start: Jan 2013 (actual)
Primary completion: Dec 2013 (actual)
Study completion: Mar 2014 (actual)
First posted: 28 Nov 2012 (estimated)
Results: Posted 14 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboThe placebo group will receive 3g per day of mineral oil during 90 days treatment
Omega3	Experimental	Drug: Omega 3The omega 3 group will receive 3g per day of fish oil during 90 days treatment

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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)

Key exclusion criteria (1 listed)

psychiatric disorders; taking psychoactive medications; history of alcohol and/or other drugs abuse or dependence;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omega 3Also: fish oil, omega 3 fatty acidEach fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.	Drug	Omega3
PlaceboAlso: mineral oilmineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule	Drug	Placebo

Primary outcome

Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment
Time frame: 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.

2 secondary outcomes

Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment
Time frame: At baseline (prior to the beginning of the treatment) and after 90 days of treatment
Concentration of Eicosapentaenoic Acid (EPA)
Time frame: At baseline (prior to the beginning of the treatment) and after 90 days of treatment

Results and safety

Results posted to the registry on 14 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	29	18
Omega3	29	21

Primary outcome: Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment

Time frame: Baseline (prior to the beginning) and after 90 days of the treatment. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 29	Omega3 n = 29
pre	6.53 (2.01)	6.56 (1.52)
post	5.96 (1.85)	5.22 (2.15)

2 secondary outcomes are reported in the full results.

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). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Group n= 29	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Omega3 Group n= 29	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. We do not plan to make individual participant data available. The data obtained was analysed and published

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

José Carlos F. Galduróz, Md PhD principal investigator

Universidade Federal de São Paulo (UNIFESP)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omega 3 in people with Tobacco Dependence and Nicotine Dependence, run by Federal University of São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment (time frame: Baseline (prior to the beginning) and after 90 days of the treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01735279.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.