SmokersNCT01734330
Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation
A study testing Cognitive behavioral therapy in group and Nicotine replacement in people with Smokers, run by Hospital do Coracao at 2 sites in Brazil.
Trial summary
Background: Pharmacological strategies to improve smoking cessation have been largely studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in tobacco cessation has not yet been demonstrated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smokers
- What is being tested?
- Cognitive behavioral therapy in group and Nicotine replacement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smokers (≥ 5 cigarettes/day during the previous year) who had not had a period of abstinence greater than 3 months before randomization
- Age ≥ 18 years < 75 years;
- Capable of reading and understanding Portuguese;
- Willing to quit smoking.
Who cannot join
- Dementia;
- Alcoholism;
- Regular use of illicit drugs;
- Panic disorders;
- Psychosis;
- Current pregnancy;
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- History of bipolar disturbance;
- Contraindication to nicotine patches;
- Prior use of bupropion and/or varenicline in the previous 12 months before randomization;
- Patients who refused to provide informed consent;
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Recife, Pernanbuco, 50070-550
Hospital do Coração
São Paulo, São Paulo, 04005000
About this study
Official title: Efficacy of Cognitive Behaviour Therapy Associated to Nicotine Replacement in Tobacco Cessation: a Randomised Open Label Clinical Trial
Background: Pharmacological strategies to improve smoking cessation have been largely studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in tobacco cessation has not yet been demonstrated.
Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52 weeks.
Read more
Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334 patients. Analysis will follow intention-to-treat principle.
Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year before randomization will be included.
All of them will receive nicotine replacement therapy with patches and gum. They will be randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first six weeks of the treatment. Every two weeks all of the patients will be evaluated by a physician in order to access any adverse effects from the nicotine replacement.
All patients will have carbon monoxide levels accessed at baseline and after 6 weeks. Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco cessation, relapses episodes and abstinence maintenance.
- Conditions
- Smokers
- Being tested
- Cognitive behavioral therapy in group, Nicotine replacement
- Keywords
- behavior cognitive therapy, Smokers, randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy in groupBehavioural
Nicotine replacementDrug
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavior therapy | Experimental | Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks Receives: Behavioral: Cognitive behavioral therapy in group; Drug: Nicotine replacement |
| Nicotine replacement | Other | Nicotine replacement for 12 weeks Receives: Drug: Nicotine replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Measured: 52 weeks
Secondary outcomes (3)
Levels of anxiety
Evaluated by the State-Trait Anxiety Inventory
Measured: 6 weeks
Levels of depression
Evaluated by Beck Depression Inventory
Measured: 6 weeks
Smoking Relapse rates
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor
- Investigators
- Silvia Ismael, Study chair, Hospital do Coração
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734330
- Sponsor's protocol ID
- 119/2010
- Status last verified
- Nov 2012
- First submitted
- 22 Nov 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cognitive Behaviour Therapy Associated to Nicotine Replacement in Tobacco Cessation: a Randomised Open Label Clinical Trial
- ClinicalTrials.gov ID
- NCT01734330
- Acronym / sponsor ID
- 119/2010
- Conditions
- Smokers
- Keywords
- behavior cognitive therapy, Smokers, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Pharmacological strategies to improve smoking cessation have been largely studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in tobacco cessation has not yet been demonstrated.
Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52 weeks.
Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334 patients. Analysis will follow intention-to-treat principle.
Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year before randomization will be included.
All of them will receive nicotine replacement therapy with patches and gum. They will be randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first six weeks of the treatment. Every two weeks all of the patients will be evaluated by a physician in order to access any adverse effects from the nicotine replacement.
All patients will have carbon monoxide levels accessed at baseline and after 6 weeks. Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco cessation, relapses episodes and abstinence maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavior therapy | Experimental | Behavioral: Cognitive behavioral therapy in group, Drug: Nicotine replacementCognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks |
| Nicotine replacement | Other | Drug: Nicotine replacementNicotine replacement for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Smokers (≥ 5 cigarettes/day during the previous year) who had not had a period of abstinence greater than 3 months before randomization
- Age ≥ 18 years < 75 years;
- Capable of reading and understanding Portuguese;
- Willing to quit smoking.
Key exclusion criteria (10 listed)
- Dementia;
- Alcoholism;
- Regular use of illicit drugs;
- Panic disorders;
- Psychosis;
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 |
|---|---|---|
| Cognitive behavioral therapy in group | Behavioural | Cognitive behavior therapy |
| Nicotine replacement | Drug | Cognitive behavior therapy, Nicotine replacement |
Primary outcome
Smoking cessation
Time frame: 52 weeks
3 secondary outcomes
Levels of anxiety
Time frame: 6 weeks
Levels of depression
Time frame: 6 weeks
Smoking Relapse rates
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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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.
Silvia Ismael study chair
Hospital do Coração
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in group and Nicotine replacement in people with Smokers, run by Hospital do Coracao at 2 sites 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 4 inclusion and 10 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 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Smoking cessation (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2012.