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

Placebo Task Clinical Trial

Official title:

Studying a Novel Intervention, the Tobacco Retraining of Automatic Approach (TRAA), to Treat Individuals With Tobacco Dependence and Severe Concurrent Disorders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01902199
• Other study ID #: H13-01422
• Status: Withdrawn
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Placebo Task
• Tobacco Retraining of Automatic Approach
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
Canada	Burnaby Centre for Mental Health and Addiction	Burnaby	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Provincial Health Services Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 12 weeks
Secondary	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.	Baseline