Attentional Training for Smoking Cessation Via Handheld Device or Personal Computer

Smoking Clinical Trial

Official title:

Attentional Training for Smoking Cessation Via Handheld Device or Personal Computer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01458834
• Other study ID #: BU-2453
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2011
• Last updated: October 22, 2011
• Start date: September 2011

Study information

• Verified date: October 2011
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18-65.

2. Familiarity with a computer keyboard and mouse.

3. 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.

4. 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Attention bias modification task
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.
• 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.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Questionnaire of Smoking Urges (QSU-Brief)		Assessed at baseline and endpoint visits (one week apart)	No
Primary	Attentional Bias Scores		Assessed at baseline and endpoint visits (one week apart)	No