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Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01734330
First received: November 22, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Smokers
Behavioral: Cognitive behavioral therapy in group
Drug: Nicotine replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Cognitive Behaviour Therapy Associated to Nicotine Replacement in Tobacco Cessation: a Randomised Open Label Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • Smoking cessation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Levels of anxiety [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Evaluated by the State-Trait Anxiety Inventory

  • Levels of depression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Evaluated by Beck Depression Inventory

  • Smoking Relapse rates [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: July 2010
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive behavior therapy
Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks
Behavioral: Cognitive behavioral therapy in group Drug: Nicotine replacement
Nicotine replacement
Nicotine replacement for 12 weeks
Drug: Nicotine replacement

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734330

Locations
Brazil
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Recife, Pernanbuco, Brazil, 50070-550
Hospital do Coração
São Paulo, SP, Brazil, 04005000
Sponsors and Collaborators
Hospital do Coracao
Ministry of Health, Brazil
Investigators
Study Chair: Silvia Ismael Hospital do Coração
  More Information

No publications provided

Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01734330     History of Changes
Other Study ID Numbers: 119/2010
Study First Received: November 22, 2012
Last Updated: November 26, 2012
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health

Keywords provided by Hospital do Coracao:
behavior cognitive therapy
Smokers
randomized clinical trial

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014