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

Primary Purpose

Tobacco Retraining of Automatic Approach, Placebo Task

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TRAA intervention
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Retraining of Automatic Approach

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Burnaby Centre for Mental Health and Addiction

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TRAA

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Carbon monoxide levels in breath
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

Fagerström test for Nicotine dependence (FTND)
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.

Full Information

First Posted
July 15, 2013
Last Updated
June 18, 2021
Sponsor
University of British Columbia
Collaborators
Provincial Health Services Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01902199
Brief Title
Tobacco Retraining of Automatic Approach to Treat Individuals With Tobacco Dependence and Severe Concurrent Disorders.
Official Title
Studying a Novel Intervention, the Tobacco Retraining of Automatic Approach (TRAA), to Treat Individuals With Tobacco Dependence and Severe Concurrent Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Provincial Health Services Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Retraining of Automatic Approach, Placebo Task

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRAA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TRAA intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Carbon monoxide levels in breath
Description
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.
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Fagerström test for Nicotine dependence (FTND)
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Schutz, MD
Organizational Affiliation
UBC/ VCH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burnaby Centre for Mental Health and Addiction
City
Burnaby
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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