- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01458834
Attentional Training for Smoking Cessation Via Handheld Device or Personal Computer
October 22, 2011 updated by: Samantha Moshier, M.A., Boston University
Several studies indicate that cigarette smokers show an attentional bias for cigarette-related cues, meaning that they more quickly detect and attend to and have more difficulty disengaging in cigarette-related information than neutral information.
This bias is associated with craving and relapse following attempts to quit.
This experiment will examine whether a computerized attentional training procedure will successfully reduce attentional bias towards smoking cues and reduce craving in regular cigarette smokers.
The attentional training will be administered in a novel format in which participants complete 5-minute long training sessions 3 times per day and can complete the trainings via home computer or handheld device such as the iPhone, Android phone, or iPod touch.
A baseline assessment in the laboratory will measure attentional bias to smoking cues and craving following smoking cue exposure.
Participants will then be randomly assigned to either the active training condition or a control condition.
In both conditions, participants will be asked to complete brief training sessions 3 times daily for one week using their personal computer or handheld device.
Following one week of training, participants will return to the lab for endpoint assessment of attentional bias and craving.
The investigators hypothesize that compared to the control condition, the active training condition will significantly reduce attentional bias toward smoking related cues and cue-induced cigarette craving.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Boston University
-
Contact:
- Samantha Moshier, MA
- Phone Number: 617-353-9610
- Email: smoshier@bu.edu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-65.
- Familiarity with a computer keyboard and mouse.
- Must own a iPhone, iPod Touch, or Google Android-based phone (such as the Droid or Nexus One) or have regular access to the Internet via personal computer.
- Current regular smoker, as defined by self-reported use of at least 1 year and a current average of at least 10 cigarettes smoked per day.
Exclusion Criteria:
1. Individuals with current suicidality (determined by a score of 2 or 3 on item 9 of the Beck Depression Inventory given following consent) will be excluded from further participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active attention training condition
|
Participants will complete a computerized probe-discrimination task from their home computer or handheld electronic device 3 times per day for one week.
Each training session will consist of 160 trials.
In each trial, two pictures (smoking-related or neutral) will appear on the screen simultaneously and then disappear.
An arrow will appear in the location of one of the pictures (< or >).
Participants are asked to quickly identify the direction of the arrow by pressing a button.
In the active training task, the arrow will replace the neutral pictures 80% of the time.
|
|
Placebo Comparator: Control condition
|
Participants will complete a computerized probe-discrimination task from their home computer or handheld electronic device 3 times per day for one week.
Each training session will consist of 160 trials.
In each trial, two pictures (smoking-related or neutral) will appear on the screen simultaneously and then disappear.
An arrow will appear in the location of one of the pictures (< or >).
Participants are asked to quickly identify the direction of the arrow by pressing a button.
In the control training task, the arrow will replace the neutral and smoking-related pictures with equal frequency.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Brief Questionnaire of Smoking Urges (QSU-Brief)
Time Frame: Assessed at baseline and endpoint visits (one week apart)
|
Assessed at baseline and endpoint visits (one week apart)
|
|
Attentional Bias Scores
Time Frame: Assessed at baseline and endpoint visits (one week apart)
|
Assessed at baseline and endpoint visits (one week apart)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Samantha Moshier, MA, Boston University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Anticipated)
July 1, 2012
Study Registration Dates
First Submitted
October 22, 2011
First Submitted That Met QC Criteria
October 22, 2011
First Posted (Estimate)
October 25, 2011
Study Record Updates
Last Update Posted (Estimate)
October 25, 2011
Last Update Submitted That Met QC Criteria
October 22, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BU-2453
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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