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Tobacco Retraining of Automatic Approach to Treat Individuals With Tobacco Dependence and Severe Concurrent Disorders.

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ClinicalTrials.gov Identifier: NCT01902199
Recruitment Status : Unknown
Verified September 2014 by University of British Columbia.
Recruitment status was:  Not yet recruiting
First Posted : July 18, 2013
Last Update Posted : October 1, 2014
Sponsor:
Collaborator:
Provincial Health Services Authority
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:

A randomized control trial evaluating a novel smoking cessation intervention in individuals at a an inpatient clinic for clients with addiction and concurrent disorders. The intervention is based on cognitive bias modification, where participants are explicitly or implicitly trained to make avoidance movements by pushing a joystick in response to pictures of smoking, and as a result altering their cognitive biases towards smoking and tobacco dependence.

Hypothesis: Participation in the experimental (tobacco-avoidance) condition will induce reduction of smoking, assessed as lower levels of carbon monoxide measured at baseline and 12 week follow-up.


Condition or disease Intervention/treatment Phase
Tobacco Retraining of Automatic Approach Placebo Task Behavioral: TRAA intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Studying a Novel Intervention, the Tobacco Retraining of Automatic Approach (TRAA), to Treat Individuals With Tobacco Dependence and Severe Concurrent Disorders
Study Start Date : October 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: TRAA
participants will be given the active TRAA intervention where landscape images are linked with a push motion, and portrait images linked with a pull motion. Pictures will exclusively be related to smoking.
Behavioral: TRAA intervention
The Tobacco Retraining of Automatic Approach The tobacco-RAA will be the intervention in changing approach tendencies towards tobacco. The task uses pictures of tobacco related objects (e.g, a cigarette) and pictures of non-tobacco related objects (e.g, a spoon). Patients will be presented with a joystick while pictures are presented on a computer screen. Patients will be presented with pictures, pulling pictures in a portrait format, while they push pictures in a landscape format. In the experimental condition pictures pushed will almost exclusively be smoking related pictures. In the control condition smoking pictures will be equally divided into push and pull conditions.

Placebo Comparator: Control
participants will be given a mix of landscape and portrait pictures, equally divided into push or pull. the images will be a mix of smoking related pictures and non smoking pictures.



Primary Outcome Measures :
  1. Carbon monoxide levels in breath [ Time Frame: baseline, 12 weeks ]
    The breath carbon monoxide monitoring device will be used both before the intervention for a baseline measure and at the 12-week follow-up for comparison. These two measurements will be used to detect changes in smoking patterns that may have occurred during this interval. The method allows to objectify abstinence from smoking.


Secondary Outcome Measures :
  1. Fagerström test for Nicotine dependence (FTND) [ Time Frame: Baseline ]
    The FTND is a 6-item questionnaire scored to test level of nicotine dependence, and will be presented to patients prior to the intervention. Patients meeting a cut-off score of 5 or higher will be eligible to participate in the intervention portion of this study.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Proficiency to read and write english
  • A minimum score of 5 or higher on the fagerström test for nicotine dependence, indicating a medium dependence
  • Current smoking will be validated by Carbon monoxide breath monitor

Exclusion Criteria:

  • Patients not yet stabilized enough to allow for regular participation in the intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902199


Contacts
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Contact: Christian Schutz, MD 604-826-4362 christian.schutz@ubc.ca

Locations
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Canada, British Columbia
Burnaby Centre for Mental Health and Addiction Not yet recruiting
Burnaby, British Columbia, Canada
Contact: Christian Schutz, MD,PhD    604-875-4111 ext 69904    christian.schuetz@vch.ca   
Sponsors and Collaborators
University of British Columbia
Provincial Health Services Authority
Investigators
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Principal Investigator: Christian Schutz, MD UBC/ VCH

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01902199     History of Changes
Other Study ID Numbers: H13-01422
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders