NCT01734330

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

November 22, 2012

Last Update Submit

November 26, 2012

Conditions

Smokers

Keywords

behavior cognitive therapySmokersrandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation

    52 weeks

Secondary Outcomes (3)

  • Levels of anxiety

    6 weeks

  • Levels of depression

    6 weeks

  • Smoking Relapse rates

    52 weeks

Study Arms (2)

Cognitive behavior therapy

EXPERIMENTAL

Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks

Behavioral: Cognitive behavioral therapy in groupDrug: Nicotine replacement

Nicotine replacement

OTHER

Nicotine replacement for 12 weeks

Drug: Nicotine replacement

Interventions

Cognitive behavioral therapy in groupBEHAVIORAL
Cognitive behavior therapy
Nicotine replacementDRUG
Cognitive behavior therapyNicotine replacement

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Dementia;
  • Alcoholism;
  • Regular use of illicit drugs;
  • Panic disorders;
  • Psychosis;
  • Current pregnancy;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto de Medicina Integral Professor Fernando Figueira - IMIP

Recife, Pernanbuco, 50070-550, Brazil

Location

Hospital do Coração

São Paulo, São Paulo, 04005000, Brazil

Location

MeSH Terms

Interventions

Cognitive Behavioral TherapyPopulation GroupsNicotine Replacement Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesDemographyPopulation CharacteristicsDrug TherapyTherapeutics

Study Officials

  • Silvia Ismael

    Hospital do Coração

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2012

First Posted

November 27, 2012

Study Start

July 1, 2010

Primary Completion

September 1, 2012

Study Completion

November 1, 2012

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

BR(2)